21 CFR Part 870 — Cardiovascular Devices

PART 870—CARDIOVASCULAR DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted. Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 870.1 Scope. (a) This part sets forth the classification of cardiovascular devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a cardiovascular device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.. [52 FR 17735, May 11, 1987, as amended at 68 FR 61344, Oct. 28, 2003; 78 FR 18233, Mar. 26, 2013] § 870.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. [52 FR 17735, May 11, 1987] § 870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2314, Jan. 14, 2000] Subpart B—Cardiovascular Diagnostic Devices § 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm). (a) Identification. (b) Classification. [68 FR 61344, Oct. 28, 2003] § 870.1100 Blood pressure alarm. (a) Identification. (b) Classification. § 870.1110 Blood pressure computer. (a) Identification. (b) Classification. § 870.1120 Blood pressure cuff. (a) Identification. (b) Classification. § 870.1130 Noninvasive blood pressure measurement system. (a) Identification. (b) Classification. § 870.1140 Venous blood pressure manometer. (a) Identification. (b) Classification. § 870.1200 Diagnostic intravascular catheter. (a) Identification. (b) Classification. § 870.1210 Continuous flush catheter. (a) Identification. (b) Classification. § 870.1220 Electrode recording catheter or electrode recording probe. (a) Identification. (b) Classification. § 870.1230 Fiberoptic oximeter catheter. (a) Identification. (b) Classification. § 870.1240 Flow-directed catheter. (a) Identification. (b) Classification. § 870.1250 Percutaneous catheter. (a) Identification. (b) Classification. § 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Simulated-use testing in a clinically relevant bench anatomic model to assess the following: (A) Delivery, deployment, and retrieval, including quantifying deployment and retrieval forces, and procedural time; and (B) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device. (ii) Tensile strengths of joints and components, tip flexibility, torque strength, torque response, and kink resistance. (iii) Flow characteristics. (A) The ability of the filter to not impede blood flow. (B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow. (iv) Characterization and verification of all dimensions. (2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed: (i) Delivery, deployment, and retrieval, including quantifying procedural time. (ii) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device. (iii) Flow characteristics. (A) The ability of the filter to not impede blood flow. (B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow. (iv) Gross pathology and histopathology assessing vascular injury and downstream embolization. (3) All patient contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Labeling for the device must include: (i) Instructions for use; (ii) Compatible transcatheter intracardiac procedure devices; (iii) A detailed summary of the clinical testing conducted; and (iv) A shelf life and storage conditions. (7) Clinical performance testing must demonstrate: (i) The ability to safely deliver, deploy, and remove the device; (ii) The ability of the device to filter embolic material while not impeding blood flow; (iii) Secure positioning and stability of the position throughout the transcatheter intracardiac procedure; and (iv) Evaluation of all adverse events including death, stroke, and vascular injury. [83 FR 4140, Jan. 30, 2018] § 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. (a) Identification. (b) Classification. (1) Clinical performance testing must evaluate: (i) The ability to safely deliver, deploy, and remove the device; (ii) The ability of the device to create an arteriovenous fistula; (iii) The ability of the arteriovenous fistula to attain a blood flow rate and diameter suitable for hemodialysis; (iv) The ability of the fistula to be used for vascular access for hemodialysis; (v) The patency of the fistula; and (vi) The rates and types of all adverse events. (2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed: (i) Delivery, deployment, and retrieval of the device; (ii) Compatibility with other devices labeled for use with the device; (iii) Patency of the fistula; (iv) Characterization of blood flow at the time of the fistula creation procedure and at chronic followup; and (v) Gross pathology and histopathology assessing vascular injury and downstream embolization. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, activation, and retrieval of the device; (ii) Tensile strengths of joints and components; (iii) Accurate positioning and alignment of the device to achieve fistula creation; and (iv) Characterization and verification of all dimensions. (4) Electrical performance, electrical safety, and electromagnetic compatibility (EMC) testing must be performed for devices with electrical components. (5) Software verification, validation, and hazard analysis must be performed for devices that use software. (6) All patient-contacting components of the device must be demonstrated to be biocompatible. (7) Performance data must demonstrate the sterility of the device components intended to be provided sterile. (8) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (9) Labeling for the device must include: (i) Instructions for use; (ii) Identification of system components and compatible devices; (iii) Expertise needed for the safe use of the device; (iv) A detailed summary of the clinical testing conducted and the patient population studied; and (v) A shelf life and storage conditions. [87 FR 9241, Feb. 18, 2022] § 870.1255 Balloon aortic valvuloplasty catheter. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible. (2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components. (3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal. (4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis. (5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device. [82 FR 34852, July 27, 2017] § 870.1270 Intracavitary phonocatheter system. (a) Identification. (b) Classification. § 870.1280 Steerable catheter. (a) Identification. (b) Classification. § 870.1290 Steerable catheter control system. (a) Identification. (b) Classification. § 870.1300 Catheter cannula. (a) Identification. (b) Classification. § 870.1310 Vessel dilator for percutaneous catheterization. (a) Identification. (b) Classification. § 870.1330 Catheter guide wire. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019] § 870.1340 Catheter introducer. (a) Identification. (b) Classification. § 870.1342 Reverse central venous recanalization system. (a) Identification. (b) Classification. (1) Clinical performance testing must fulfill the following: (i) Demonstrate the ability to safely deliver, deploy, and remove the device; and (ii) Evaluate all adverse events including death, bleeding, damage to non-target tissue and organs, blood vessel perforation or rupture, and hematoma. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, and retrieval of the system; (ii) Compatibility with other devices labeled for use with the device; (iii) Tensile strengths of joints and components; (iv) Kink resistance of system components; (v) Radiopacity of components used to monitor procedure under fluoroscopy; (vi) Characterization and verification of all dimensions; and (vii) Leakage of air or fluid. (3) All patient contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components intended to be provided sterile. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Labeling for the device must include: (i) Instructions for use, including a description of compatible devices; (ii) A detailed summary of the clinical testing conducted and; (iii) Shelf life and storage conditions. [87 FR 26991, May 6, 2022] § 870.1345 Intravascular bleed monitor. (a) Identification. (b) Classification. (1) In vivo animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following: (i) Device performance characteristics; (ii) Adverse effects, including gross necropsy and histopathology; and (iii) Device usability, including device preparation, device handling, and user interface. (2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Tensile testing of joints and materials; (ii) Mechanical integrity testing; (iii) Friction testing; (iv) Flush testing; (v) Air leakage and liquid leakage testing; (vi) Latching and unlatching testing; (vii) Kink and bend testing; (viii) Insertion force testing; (ix) Torque testing; (x) Corrosion testing; and (xi) Dimensional tolerance testing. (3) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile. (4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (5) The patient contacting components of the device must be demonstrated to be biocompatible. (6) Software verification, validation, and hazard analysis must be performed. (7) Performance data must demonstrate electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety. (8) Human factors performance evaluation must demonstrate that the user can correctly use the device, based solely on reading the directions for use. (9) Labeling must include: (i) Instructions for use; (ii) A shelf life and storage conditions; (iii) Compatible procedures; (iv) A sizing table; and (v) Quantification of blood detected. [87 FR 34778, June 8, 2022] § 870.1350 Catheter balloon repair kit. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] § 870.1360 Trace microsphere. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] § 870.1370 Catheter tip occluder. (a) Identification. (b) Classification. § 870.1380 Catheter stylet. (a) Identification. (b) Classification. § 870.1390 Trocar. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019] § 870.1405 Interventional cardiovascular implant simulation software device. (a) Identification. (b) Classification. (1) Software verification, validation, and hazard analysis, with identification of appropriate mitigations, must be performed, including a full verification and validation of the software according to the predefined software specifications. (2) Computational modeling verification and validation activities must be performed to establish the predictive capability of the device for its indications for use. (3) Performance validation testing must be provided to demonstrate the accuracy and clinical relevance of the modeling methods for the intended implantation simulations, including the following: (i) Computational modeling results must be compared to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations; (ii) Agreement between computational modeling results and clinical data must be assessed and demonstrated across the full intended operating range ( e.g., (iii) Endpoints ( e.g., (iv) Validation must be performed and controls implemented to characterize and ensure consistency ( i.e., (A) Testing must be performed using multiple qualified operators and using the procedure that will be implemented under anticipated conditions of use; and (B) The factors ( e.g., (4) Human factors evaluation must be performed to evaluate the ability of the user interface and labeling to allow for intended users to correctly use the device and interpret the provided information. (5) Device labeling must be provided that describes the following: (i) Warnings that identify anatomy and image acquisition factors that may impact simulation results and provide cautionary guidance for interpretation of the provided simulation results; (ii) Device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs; and (iii) The computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance. [87 FR 79803, Dec. 28, 2022] § 870.1415 Coronary vascular physiologic simulation software device. (a) Identification. e.g., (b) Classification. (1) Adequate software verification and validation based on comprehensive hazard analysis, with identification of appropriate mitigations, must be performed, including: (i) Full characterization of the technical parameters of the software, including: (A) Any proprietary algorithm(s) used to model the vascular anatomy; and (B) Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications; (ii) Adequate consideration of privacy and security issues in the system design; and (iii) Adequate mitigation of the impact of failure of any subsystem components ( e.g., (2) Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement; and (3) Clinical data supporting the proposed intended use must be provided, including the following: (i) Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner; (ii) Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests ( e.g., (iii) Statistical performance of the device within clinical risk strata ( e.g., (iv) The dataset must be adequately representative of the intended use population for the device ( e.g., (v) Statistical methods must consider the predefined endpoints: (A) Estimates of probabilities of incorrect results must be provided for each endpoint, (B) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification, and (C) The report must provide appropriate confidence intervals for each performance metric; (vi) Sensitivity and specificity must be characterized across the range of available measurements; (vii) Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements; (viii) Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and (ix) If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation, and it must be justified as to how it was determined and clinically validated; (4) Adequate validation must be performed and controls implemented to characterize and ensure consistency ( i.e., (i) Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified, and (ii) Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency ( i.e., (A) Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device, and (B) The factors ( e.g., (5) Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention; and (6) Device labeling must be provided that adequately describes the following: (i) The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended; (ii) Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements; (iii) Key assumptions made in the calculation and determination of simulated measurements; (iv) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data; (v) A detailed description of the patients studied in the clinical validation ( e.g., e.g., (vi) Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results. [80 FR 63673, Oct. 21, 2015] § 870.1420 Coronary artery disease risk indicator using acoustic heart signals. (a) Identification. (b) Classification. (1) Clinical performance testing must fulfill the following: (i) Testing must include a discussion of the patient population and any statistical techniques used for analyzing the data; and (ii) Testing must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified. (2) Acoustic performance testing must evaluate microphone sensitivity, sound acquisition bandwidth, and amplitude accuracy. The acoustic sensor specifications and mechanism used to capture heart sounds must be described. (3) A scientific justification for the validity of the algorithm(s) must be provided. This justification must fulfill the following: (i) All inputs and outputs of the algorithm must be fully described; (ii) The procedure for segmenting, characterizing, and classifying the acoustic signal must be fully described; and (iii) This justification must include verification of the algorithm calculations and validation using an independent data set. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Software verification, validation, and hazard analysis must be performed. (6) Human factors/usability testing must demonstrate that the user can correctly use the device, including device placement, based solely on reading the directions for use. (7) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device. (8) Labeling must include the following: (i) A description of what the device measures and outputs to the user; (ii) Instructions for proper placement of the device; (iii) Instructions on care and cleaning of the device; (iv) Warnings identifying sensor acquisition factors that may impact measurement results and instructions for mitigating these factors; and (v) The expected performance of the device for all intended use populations and environments. [87 FR 32990, June 1, 2022] § 870.1425 Programmable diagnostic computer. (a) Identification. (b) Classification. § 870.1435 Single-function, preprogrammed diagnostic computer. (a) Identification. (b) Classification. § 870.1450 Densitometer. (a) Identification. (b) Classification. § 870.1650 Angiographic injector and syringe. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019] § 870.1660 Indicator injector. (a) Identification. (b) Classification. § 870.1670 Syringe actuator for an injector. (a) Identification. (b) Classification. § 870.1750 External programmable pacemaker pulse generator. (a) Identification. (b) Classification. § 870.1800 Withdrawal-infusion pump. (a) Identification. (b) Classification. § 870.1875 Stethoscope. (a) Manual stethoscope Identification. (2) Classification. (b) Electronic stethoscope Identification. (2) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019] § 870.1915 Thermodilution probe. (a) Identification. (b) Classification. Subpart C—Cardiovascular Monitoring Devices § 870.2050 Biopotential amplifier and signal conditioner. (a) Identification. (b) Classification. § 870.2060 Transducer signal amplifier and conditioner. (a) Identification. (b) Classification. § 870.2100 Cardiovascular blood flowmeter. (a) Identification. (b) Classification. § 870.2120 Extravascular blood flow probe. (a) Identification. (b) Classification. § 870.2200 Adjunctive cardiovascular status indicator. (a) Identification. (b) Classification. (1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including: (i) Full characterization of technical parameters of the software, including any proprietary algorithm(s); (ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications; (iii) Specification of acceptable incoming sensor data quality control measures; and (iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports. (2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling. (3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated. (4) Clinical data must be provided in support of the intended use and include the following: (i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner; (ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified; (iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and (iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment. (5) Labeling must include the following: (i) The type of sensor data used, including specification of compatible sensors for data acquisition; (ii) A description of what the device measures and outputs to the user; (iii) Warnings identifying sensor reading acquisition factors that may impact measurement results; (iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements; (v) Key assumptions made in the calculation and determination of measurements; (vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and (vii) A detailed description of the patients studied in the clinical validation ( e.g., [82 FR 35067, July 28, 2017] § 870.2210 Adjunctive predictive cardiovascular indicator. (a) Identification. (b) Classification. (1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must be provided, including: (i) A full characterization of the software technical parameters, including algorithms; (ii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications; (iii) A description of sensor data quality control measures; (iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; (v) A description of the expected time to patient status or clinical event for all expected outputs, accounting for differences in patient condition and environment; and (vi) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form. (2) A scientific justification for the validity of the predictive cardiovascular indicator algorithm(s) must be provided. This justification must include verification of the algorithm calculations and validation using an independent data set. (3) A human factors and usability engineering assessment must be provided that evaluates the risk of misinterpretation of device output. (4) A clinical data assessment must be provided. This assessment must fulfill the following: (i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data. (ii) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified. (iii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment. (iv) The assessment must evaluate how the device output correlates with the predicted event or status. (5) Labeling must include: (i) A description of what the device measures and outputs to the user; (ii) Warnings identifying sensor acquisition factors that may impact measurement results; (iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information; (iv) A specific time or a range of times before the predicted patient status or clinical event occurs, accounting for differences in patient condition and environment; (v) Key assumptions made during calculation of the output; (vi) The type(s) of sensor data used, including specification of compatible sensors for data acquisition; (vii) The expected performance of the device for all intended use populations and environments; and (viii) Relevant characteristics of the patients studied in the clinical validation (including age, gender, race or ethnicity, and patient condition) and a summary of validation results. [87 FR 8191, Feb. 14, 2022] § 870.2220 Adjunctive hemodynamic indicator with decision point. (a) Identification. (b) Classification. (1) Software description, verification, and validation based on comprehensive hazard analysis and risk assessment must be provided, including: (i) Full characterization of technical parameters of the software, including algorithm(s); (ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications; (iii) Specification of acceptable incoming sensor data quality control measures; (iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on output accuracy; and (v) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form for clinically meaningful pre-specified time windows consistent with the device output. (2) Scientific justification for the validity of the hemodynamic indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm must use an independent data set. (3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated. (4) Clinical data must support the intended use and include the following: (i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data; (ii) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output represents the measure(s) that the device provides in an accurate and reproducible manner; (iii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified; (iv) Where continuous measurement variables are displayed, agreement of the output with the reference measure(s) must be assessed across the full measurement range; and (v) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment. (5) Labeling must include the following: (i) The type of sensor data used, including specification of compatible sensors for data acquisition, and a clear description of what the device measures and outputs to the user; (ii) Warnings identifying factors that may impact output results; (iii) Guidance for interpretation of the outputs, including warning(s) specifying adjunctive use of the measurements; (iv) Key assumptions made in the calculation and determination of measurements; and (v) A summary of the clinical validation data, including details of the patient population studied ( e.g., [87 FR 79254, Dec. 27, 2022] § 870.2300 Cardiac monitor (including cardiotachometer and rate alarm). (a) Identification. (b) Classification. § 870.2310 Apex cardiograph (vibrocardiograph). (a) Identification. (b) Classification. § 870.2320 Ballistocardiograph. (a) Identification. (b) Classification. § 870.2330 Echocardiograph. (a) Identification. (b) Classification. § 870.2340 Electrocardiograph. (a) Identification. (b) Classification. § 870.2345 Electrocardiograph software for over-the-counter use. (a) Identification. (b) Classification. (1) Clinical performance testing under anticipated conditions of use must demonstrate the following: (i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and (ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value. (2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs. (3) Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set. (4) Human factors and usability testing must demonstrate the following: (i) The user can correctly use the device based solely on reading the device labeling; and (ii) The user can correctly interpret the device output and understand when to seek medical care. (5) Labeling must include: (i) Hardware platform and operating system requirements; (ii) Situations in which the device may not operate at an expected performance level; (iii) A summary of the clinical performance testing conducted with the device; (iv) A description of what the device measures and outputs to the user; and (v) Guidance on interpretation of any results. [86 FR 2549, Jan. 18, 2022] § 870.2350 Electrocardiograph lead switching adaptor. (a) Identification. (b) Classification. § 870.2360 Electrocardiograph electrode. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 76 FR 43585, July 21, 2011] § 870.2370 Electrocardiograph surface electrode tester. (a) Identification. (b) Classification. § 870.2390 Phonocardiograph. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.2400 Vectorcardiograph. (a) Identification. (b) Classification. § 870.2450 Medical cathode-ray tube display. (a) Identification. (b) Classification. § 870.2600 Signal isolation system. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.2620 Line isolation monitor. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.2640 Portable leakage current alarm. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.2675 Oscillometer. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.2700 Oximeter. (a) Identification. (b) Classification. § 870.2710 Ear oximeter. (a) Identification. (b) Classification. § 870.2750 Impedance phlebograph. (a) Identification. (b) Classification. § 870.2770 Impedance plethysmograph. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs. (a) Identification. (b) Classification. § 870.2785 Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. (a) Identification. (b) Classification. (1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include: (i) A full characterization of the software technical parameters, including algorithms; (ii) If required image acquisition hardware is not included with the device, full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements; (iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications; (iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and (v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality. (2) Clinical data must be provided. This assessment must fulfill the following: (i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified. (ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment. (iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner. (3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement. (4) Labeling must include: (i) A description of what the device measures and outputs to the user; (ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results; (iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information; (iv) The expected performance of the device for all intended use populations and environments; and (v) Robust instructions to ensure correct system setup. [88 CFR 6167, Jan. 31, 2023] § 870.2786 Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. (a) Identification. (b) Classification. (1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include: (i) A full characterization of the software technical parameters, including algorithms; (ii) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and (iii) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality. (2) Performance testing must demonstrate the safety of any illuminating optics. (3) Clinical data must be provided. This assessment must fulfill the following: (i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified. (ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment. (iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner. (4) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement. (5) Labeling must include: (i) A description of what the device measures and outputs to the user; (ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results; (iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information; (iv) The expected performance of the device for all intended use populations and environments; and (v) Robust instructions to ensure correct system setup. [88 FR 976, Jan. 6, 2023] § 870.2790 Photoplethysmograph analysis software for over-the-counter use. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use. (2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs. (3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality. (4) Human factors and usability testing must demonstrate the following: (i) The user can correctly use the device based solely on reading the device labeling; and (ii) The user can correctly interpret the device output and understand when to seek medical care. (5) Labeling must include: (i) Hardware platform and operating system requirements; (ii) Situations in which the device may not operate at an expected performance level; (iii) A summary of the clinical performance testing conducted with the device; (iv) A description of what the device measures and outputs to the user; and (v) Guidance on interpretation of any results. [87 FR 6419, Feb. 4, 2022] § 870.2800 Medical magnetic tape recorder. (a) Identification. (b) Classification. § 870.2810 Paper chart recorder. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.2840 Apex cardiographic transducer. (a) Identification. (b) Classification. § 870.2850 Extravascular blood pressure transducer. (a) Identification. (b) Classification. § 870.2855 Implantable Intra-aneurysm Pressure Measurement System. (a) Identification. (b) Classification. [71 FR 7871, Feb. 15, 2006] § 870.2860 Heart sound transducer. (a) Identification. (b) Classification. § 870.2870 Catheter tip pressure transducer. (a) Identification. (b) Classification. § 870.2880 Ultrasonic transducer. (a) Identification. (b) Classification. § 870.2890 Vessel occlusion transducer. (a) Identification. (b) Classification. § 870.2900 Patient transducer and electrode cable (including connector). (a) Identification. (b) Classification. § 870.2910 Radiofrequency physiological signal transmitter and receiver. (a) Identification. (b) Classification. § 870.2920 Telephone electrocardiograph transmitter and receiver. (a) Identification. (b) Classification. Subpart D—Cardiovascular Prosthetic Devices § 870.3250 Vascular clip. (a) Identification. (b) Classification. § 870.3260 Vena cava clip. (a) Identification. (b) Classification. § 870.3300 Vascular embolization device. (a) Identification. (b) Classification. [69 FR 77899, Dec. 29, 2004] § 870.3375 Cardiovascular intravascular filter. (a) Identification. (b) Classification. (1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and (2) FDA's: (i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.” [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 65 FR 17144, Mar. 31, 2000] § 870.3450 Vascular graft prosthesis. (a) Identification. (b) Classification. [66 FR 18542, Apr. 10, 2001] § 870.3460 Endovascular Suturing System. (a) Identification. (b) Classification. (1) The device should be demonstrated to be biocompatible; (2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment; (4) Non-clinical testing should evaluate the compatibility of the device in an magnetic resonance (MR) environment; (5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety; (6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and (7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device. [77 FR 8119, Feb. 14, 2012] § 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. (a) Identification. (b) Classification. § 870.3535 Intra-aortic balloon and control system. (a) Identification. (b) Classification. (i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device; (ii) Software verification, validation, and hazard analysis must be performed; (iii) The device must be demonstrated to be biocompatible; (iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; (v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and (vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device. (2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. [78 FR 79303, Dec. 31, 2013] § 870.3545 Ventricular bypass (assist) device. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 76 FR 50666, Aug. 16, 2011] § 870.3600 External pacemaker pulse generator. (a) Identification. (b) Classification. (1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment. (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source ( i.e., (3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling; (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use; (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices ( e.g. (iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated. (4) Appropriate software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use; (ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals; (iii) The labeling must list all pacing modes available in the device; (iv) Labeling must include a detailed description of any special capabilities ( e.g., (v) Appropriate electromagnetic compatibility information must be included. [81 FR 22529, Apr. 18, 2016] § 870.3605 Pacing system analyzer. (a) Identification. (b) Classification. (1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment. (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source ( i.e., (3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling; (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use; (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices ( e.g. (iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated. (4) Appropriate software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use; (ii) Connector terminals should be clearly, unambiguously marked on the outside of the PSA. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals. Triple chamber devices should clearly identify atrial, right ventricular, and left ventricular terminals; (iii) The labeling must list all pacing modes available in the device; (iv) Labeling must include a detailed description of any special capabilities ( e.g., (v) Labeling must limit the use of external pacing to the implant procedure; and (vi) Appropriate electromagnetic compatibility information must be included. [81 FR 22350, Apr. 18, 2016] § 870.3610 Implantable pacemaker pulse generator. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 37576, June 22, 2012] § 870.3620 Pacemaker lead adaptor. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001] § 870.3630 Pacemaker generator function analyzer. (a) Identification. (b) Classification. § 870.3640 Indirect pacemaker generator function analyzer. (a) Identification. (b) Classification. § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.3670 Pacemaker charger. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.3680 Cardiovascular permanent or temporary pacemaker electrode. (a) Temporary pacemaker electrode Identification. external (2) Classification. (b) Permanent pacemaker electrode Identification. (2) Classification. (c) Date PMA or notice of completion of PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 39927, July 6, 2012] § 870.3690 Pacemaker test magnet. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.3700 Pacemaker programmers. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 37573, June 22, 2012] § 870.3710 Pacemaker repair or replacement material. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 76 FR 50666, Aug. 16, 2011] § 870.3720 Pacemaker electrode function tester. (a) Identification. (b) Classification. § 870.3730 Pacemaker service tools. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001] § 870.3800 Annuloplasty ring. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001] § 870.3850 Carotid sinus nerve stimulator. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] § 870.3925 Replacement heart valve. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 18163, May 13, 1987; 52 FR 23137, June 17, 1987] § 870.3935 Prosthetic heart valve holder. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996] § 870.3945 Prosthetic heart valve sizer. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001] Subpart E—Cardiovascular Surgical Devices § 870.4075 Endomyocardial biopsy device. (a) Identification. (b) Classification. § 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. (a) Identification. e.g., (b) Classification (1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible; (2) The devices and accessories in the circuit must be demonstrated to be biocompatible; (3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories; (4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability; (5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and (6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure. [81 FR 7451, Feb. 12, 2016] § 870.4150 Extracorporeal system for carbon dioxide removal. (a) Identification. e.g., (b) Classification. (1) In vivo evaluation, which may include animal testing and clinical data, of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the in vivo evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness. (2) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible. (3) Non-clinical performance testing of the devices and accessories in the circuit must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical integrity; (ii) Durability; and (iii) Reliability. (4) All patient contacting components of the device must be demonstrated to be biocompatible. (5) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of any electrical components. (6) Software validation, verification, and hazard analysis must be performed. (7) Performance testing must demonstrate the sterility of all patient-contacting components. (8) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (9) Labeling must include the following: (i) A detailed summary of the non-clinical and in vivo evaluations pertinent to use of the device and accessories in the circuit; (ii) Adequate instructions with respect to circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure; and (iii) A shelf life. [87 FR 80039, Dec. 29, 2022] § 870.4200 Cardiopulmonary bypass accessory equipment. (a) Identification. (b) Classification. (2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows: (i) The performance standard under part 898 of this chapter, and (ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9. [65 FR 19319, Apr. 11, 2000] § 870.4205 Cardiopulmonary bypass bubble detector. (a) Identification. (b) Classification. § 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing. (a) Identification. (b) Classification. § 870.4220 Cardiopulmonary bypass heart-lung machine console. (a) Identification. (b) Classification. § 870.4230 Cardiopulmonary bypass defoamer. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] § 870.4240 Cardiopulmonary bypass heat exchanger. (a) Identification. (b) Classification. § 870.4250 Cardiopulmonary bypass temperature controller. (a) Identification. (b) Classification. § 870.4260 Cardiopulmonary bypass arterial line blood filter. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] § 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter. (a) Identification. (b) Classification. § 870.4280 Cardiopulmonary prebypass filter. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.4300 Cardiopulmonary bypass gas control unit. (a) Identification. (b) Classification. § 870.4310 Cardiopulmonary bypass coronary pressure gauge. (a) Identification. (b) Classification. § 870.4320 Cardiopulmonary bypass pulsatile flow generator. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 69 FR 34920, June 23, 2004] § 870.4330 Cardiopulmonary bypass on-line blood gas monitor. (a) Identification. (b) Classification. § 870.4340 Cardiopulmonary bypass level sensing monitor and/or control. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.4350 Cardiopulmonary bypass oxygenator. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] § 870.4360 Nonroller-type blood pump. (a) Nonroller-type cardiopulmonary and circulatory bypass blood pump Identification. (i) Full or partial cardiopulmonary bypass ( i.e., (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. (2) Classification (i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability; (ii) The patient-contacting components of the device must be demonstrated to be biocompatible; (iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and (iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device. (b) Nonroller-type temporary ventricular support blood pump Identification. (2) Classification. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. [80 FR 32311, June 8, 2015] § 870.4370 Roller-type cardiopulmonary bypass blood pump. (a) Identification. (b) Classification. § 870.4380 Cardiopulmonary bypass pump speed control. (a) Identification. (b) Classification. § 870.4390 Cardiopulmonary bypass pump tubing. (a) Identification. (b) Classification. § 870.4400 Cardiopulmonary bypass blood reservoir. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.4410 Cardiopulmonary bypass in-line blood gas sensor. (a) Identification. (b) Classification. § 870.4420 Cardiopulmonary bypass cardiotomy return sucker. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.4430 Cardiopulmonary bypass intracardiac suction control. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019] § 870.4450 Vascular clamp. (a) Identification. (b) Classification. § 870.4475 Surgical vessel dilator. (a) Identification. (b) Classification. § 870.4500 Cardiovascular surgical instruments. (a) Identification. (b) Classification. [45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001] § 870.4510 Apical closure device. (a) Identification. (b) Classification. (1) The patient contacting materials must be evaluated to be biocompatible. (2) Performance data must validate the sterility of the patient-contacting components of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (4) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Consistent and reliable implant deployment; (ii) Assessment of implant pull-out force; and (iii) Sheath size compatibility with implant. (5) In vivo evaluation of the device must demonstrate device performance, including device operation resulting in closure of the myocardial wound. (6) Labeling must include the following: (i) Detailed information explaining how the device operates; (ii) Sheath size that device can accommodate; (iii) Identification of the minimum myocardial wall thickness to ensure optimal device function; and (iv) A shelf life. [81 FR 71371, Oct. 17, 2016] § 870.4600 Extravascular support for an arteriovenous fistula for vascular access. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate: (i) The ability to safely implant the device; (ii) The ability of the arteriovenous fistula supported by the device to attain a blood flow rate and diameter suitable for hemodialysis; (iii) The ability of the fistula to be used for vascular access; (iv) The primary, assisted primary, and secondary patency of the fistula; (v) The rates and types of device integrity events and any associated clinical sequelae; (vi) The rates and types of all adverse events; and (vii) The rates and outcomes of reinterventions. (2) If FDA determines that premarket clinical information is insufficient to evaluate long-term safety and effectiveness of the product, postmarket data must be collected through an adequately designed and powered postmarket study to assess the following: (i) The functionality and patency of the fistula through a clinically meaningful timeframe; (ii) The rates and types of access-related, reintervention-related, and cannulation-related adverse events; and (iii) The reasons for, rates, types, and outcomes of reinterventions. (3) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed: (i) Implantation of the device; (ii) Patency of the fistula; and (iii) Gross pathology and histopathology assessing vascular injury and downstream embolization. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Resistance to kinking; (ii) Resistance to crush and local compression; (iii) Tensile strength of joints and components; (iv) Device integrity; (v) Corrosion resistance; and (vi) Characterization and verification of all dimensions. (5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment. (6) All patient-contacting components of the device must be demonstrated to be biocompatible. (7) Performance data must demonstrate sterility of the device components intended to be provided sterile. (8) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (9) Labeling for the device must include: (i) Specific instructions regarding device size selection and device placement; (ii) Expertise needed for safe use of the device; (iii) A detailed summary of the clinical testing conducted and the patient population studied, including information on effectiveness and device- and procedure-related complications; (iv) A detailed summary of the device technical parameters; (v) A shelf life and storage conditions; and (vi) MR information. [91 FR 57499, Sept. 10, 2026] § 870.4875 Intraluminal artery stripper. (a) Identification. (b) Classification. § 870.4885 External vein stripper. (a) Identification. (b) Classification. Subpart F—Cardiovascular Therapeutic Devices § 870.5050 Patient care suction apparatus. (a) Identification. (b) Classification. § 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. (a) Standard PTCA Catheter Identification. (2) Classification. (b) Cutting/scoring PTCA Catheter Identification. (2) Classification. [75 FR 54496, Sept. 8, 2010] § 870.5125 Laser-powered inferior vena cava filter retrieval catheter. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Evaluation of major and minor complications associated with IVC filter removal; and (ii) Evaluation of success rates of IVC filter removal. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Dimensional testing must demonstrate that the device is compatible with the intended anatomy and compatible with all labeled accessories. (ii) Mechanical testing on all joints must demonstrate that the device can withstand tensile and torsional forces encountered under challenging clinical use conditions. (iii) Simulated use testing must demonstrate that the device can be inserted, tracked, activated, and removed without device damage and that the device is able to function as intended ( e.g., (iv) Performance testing must demonstrate that the product is visible under fluoroscopic techniques. (v) Performance testing must demonstrate that the device does not kink when subjected to clinically relevant tortuosity. (3) Compatibility testing with laser generators must include: (i) Electrical safety, electromagnetic compatibility testing, and electromagnetic interference testing must be conducted for all devices that contain electrical components. (ii) Software verification, validation, and hazard analysis must be conducted for all devices that contain software. (iii) Laser output characterization and performance testing, including verification of calibration reliability, energy output, and repetition rate, and laser lifetime testing, must be conducted. (4) All patient-contacting components must be demonstrated to be biocompatible. (5) Performance data must demonstrate the sterility and non-pyrogenicity of patient contacting components of the device that are provided sterile. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and system functionality over the established shelf life. (7) In vivo safety testing must demonstrate that the device does not cause soft tissue damage or device damage under worst case clinical use conditions. (8) Labeling must include the following: (i) A detailed summary of the device technical parameters and materials of the device; (ii) A summary of the clinical performance testing conducted with the device; and (iii) A shelf life. (9) A training program must be provided to ensure that users can safely and reliably use the device per its instructions for use. [91 FR 23163, Apr. 30, 2026] § 870.5150 Embolectomy catheter. (a) Identification. (b) Classification. § 870.5175 Septostomy catheter. (a) Identification. (b) Classification. § 870.5200 External cardiac compressor. (a) Identification. e.g., (b) Classification. (1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use. (2) Labeling must include the following: (i) The clinical training necessary for the safe use of this device; (ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling; (iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations, e.g., (iv) Information on the time necessary to deploy the device as demonstrated in the performance testing. (3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device. (5) For devices containing software, software verification, validation, and hazard analysis must be performed. (6) Components of the device that come into human contact must be demonstrated to be biocompatible. [81 FR 33133, May 25, 2016] § 870.5210 Cardiopulmonary resuscitation (CPR) aid. (a) CPR aid without feedback Identification. (2) Classification. (b) CPR aid with feedback Identification. (2) Classification. (i) Nonclinical performance testing under simulated physiological or use conditions must demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use. (ii) Labeling must include the clinical training, if needed, for the safe use of this device and information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations, e.g., (iii) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (iv) For devices containing software, software verification, validation, and hazard analysis must be performed. (v) Components of the device that come into human contact must be demonstrated to be biocompatible. (vi) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user. (3) Premarket notification. e.g., [81 FR 33134, May 25, 2016] § 870.5225 External counter-pulsating device. (a) Identification. (b) Classification. (i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition; (ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules; (iii) Software design and verification and validation must be appropriately documented; (iv) The skin-contacting components of the device must be demonstrated to be biocompatible; (v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and (vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device. (2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. [78 FR 79307, Dec. 30, 2013] § 870.5300 DC-defibrillator (including paddles). (a) Low-energy DC-defibrillator Identification. (2) Classification. (b) High-energy DC-defibrillator Identification. (2) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 61 FR 50706, Sept. 27, 1996] § 870.5310 Automated external defibrillator system. (a) Identification. e.g., (b) Classification. (c) Date PMA or notice of completion of PDP is required. [68 FR 61344, Oct. 28, 2003; 69 FR 10615, Mar. 8, 2004, as amended at 80 FR 5682, Feb. 3, 2015] § 870.5325 Defibrillator tester. (a) Identification. (b) Classification. § 870.5550 External transcutaneous cardiac pacemaker (noninvasive). (a) Identification. (b) Classification. (1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and (2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.” [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000] § 870.5600 Adjunctive open loop fluid therapy recommender. (a) Identification. (b) Classification. (1) Clinical performance testing under anticipated conditions of use must fulfill the following: (i) A summary of the clinical performance testing must include the relevant patient demographics, and any statistical techniques used for analyzing the data; (ii) Subjects must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified; (iii) Testing must demonstrate the recommendation consistency using the expected range of data sources and data quality encountered in the intended patients, users, and environments; and (iv) Testing must evaluate the relationship between algorithm recommendations, therapeutic actions, and predicted physiological event or status. (2) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must be provided, including: (i) A full characterization of the software technical parameters, including algorithms; (ii) A description of the expected recommendation, accounting for differences in patient condition and environment; (iii) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) that affect the device's recommendations; (iv) A characterization of algorithm sensitivity to variations in user inputs; (v) A characterization of sensor accuracy and performance; (vi) A description of sensor data quality control measures; and (vii) Safeguards to reduce the possibility of fluid overload. (3) A scientific justification for the validity of the algorithm(s) must be provided. This justification must include non-clinical verification and validation of the algorithm calculations and clinical validation using an independent data set. (4) A human factors and usability engineering assessment must be provided. (5) Labeling must include: (i) A description of what the device measures, how the device decides to issue recommendations, and the expected range of frequency of recommendations, while accounting for differences in patient condition and environment; (ii) Detailed information regarding limitations of the device's algorithm, and key assumptions made when the device issues a recommendation; (iii) Warnings identifying sensor acquisition factors that may impact measurement results; (iv) Warnings identifying user errors that affect the device's recommendations; (v) Detailed information regarding the expected impact of user input errors on the device recommendations; (vi) Guidance for interpretation of the device's recommendations, including a description that the recommendation is adjunctive to other physical vital sign parameters and patient information; (vii) Description of the impact of the compatible sensor(s) on the device's performance; (viii) The expected performance of the device for all intended patients, users, and environments; (ix) Relevant characteristics of the patients studied in the clinical validation (such as age, gender, race or ethnicity, and patient condition) and a summary of validation results; and (x) Description of the software safeguards that are in place to prevent fluid overload, and description of any limitation of the software safeguards. [89 FR 72319, Sept. 5, 2024] § 870.5700 Steerable cardiac ablation catheter remote control system. (a) Identification. (b) Classification. (1) Non-clinical mechanical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be performed: (i) Mechanical performance of the system (without catheter connected); (ii) Mechanical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following: (A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and (B) Evaluation of the accuracy and function of all device control safety features; and (iii) Simulated-use testing in a bench anatomic model or animal model. (2) Non-clinical electrical testing must include validation of electromagnetic compatibility (EMC), electrical safety, thermal safety, and electrical system performance. The following performance testing must be performed: (i) Electrical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following: (A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and (B) Evaluation of the accuracy and function of all device control safety features; and (ii) Electrical safety between the device and ablation catheter system and with other electrical equipment expected in the catheter lab or operating room. (3) In vivo testing must demonstrate that the device performs as intended under anticipated conditions of use, including an assessment of the system impact on the functionality and performance of compatible catheters, and documentation of the adverse event profile associated with clinical use. Evidence must be submitted to address the following: (i) Manipulation and Positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and confirm proper anatomic placement and tissue contact, in accordance with the system indications for use and the compatible catheter indications for use; (ii) Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; (iii) Efficacy: Assess ablation success in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; and (iv) User assessment of device remote controls and safety features. (4) Post-market surveillance (PMS) must be conducted and completed in accordance with FDA agreed upon PMS protocol. (5) A training program must be included with sufficient educational elements that, upon completion of the training program, the clinician and supporting staff can: (i) Identify the safe environments for device use, (ii) Use all safety features of device, and (iii) Operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters. (6) Performance data must demonstrate the sterility of the sterile disposable components of the system. (7) Performance data must support shelf life by demonstrating continued sterility of the device (of the sterile disposable components), package integrity, and device functionality over the requested shelf life. (8) Labeling must include the following: (i) Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the safe use of the device; (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters; (B) Instructions and explanation of all controls, inputs, and outputs; (C) Instructions on all available modes or states of the device; (D) Instructions on all safety features of the device; and (E) Validated methods and instructions for reprocessing/disinfecting any reusable components; (iii) A detailed summary of the mechanical compatibility testing including: (A) A table with a complete list of compatible catheters tested (manufacturer trade name and model number), and (B) A table with detailed test results, including type of test, acceptance criteria, and test results ( i.e., (iv) A detailed summary of the in vivo testing including: (A) A table with a complete list of compatible catheters used during testing (manufacturer trade name and model number); (B) Adverse events encountered pertinent to use of the device under use conditions; (C) A detailed summary of the device- and procedure-related complications; and (D) A summary of study outcomes and endpoints. Information pertinent to the fluoroscopy times/exposure for the procedure, patient, and operator fluoroscopic exposure; (v) Other labeling items: (A) A detailed summary of pertinent non-clinical testing information: EMC, mechanical, electrical, and sterilization of device and components; (B) A detailed summary of the device technical parameters; and (C) An expiration date/shelf life and storage conditions for the sterile accessories; and (vi) When available, and according to the timeframe included in the PMS protocol agreed upon with FDA, provide a detailed summary of the PMS data including: (A) Updates to the labeling to accurately reflect outcomes or necessary modifications based upon data collected during the PMS experience, and (B) Inclusion of results and adverse events associated with utilization of the device during the PMS. [80 FR 58606, Sept. 30, 2015] § 870.5710 Mechanical deviation device for esophageal protection during cardiac ablation procedures. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of reduction of the incidence of esophageal injury during cardiac ablation procedures; and (ii) Evaluation of any esophageal or oral injury from use of the device. (2) Animal performance testing must demonstrate that the device performs as intended under the anticipated conditions of use and include the following: (i) Evaluation of the device's capability to adequately deviate the esophagus, including its trailing edge, away from the source of ablation energy; and (ii) Evaluation of any esophageal injury from use of the device. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Mechanical integrity testing using clinically relevant forces; and (ii) Compatibility testing with accessory devices. (4) Performance data must demonstrate the sterility of any device components intended to be provided sterile. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the identified shelf life. (7) Labeling must include the following: (i) A summary of clinical performance testing with the device; and (ii) A shelf life. [91 FR 57497, Sept. 10, 2026] § 870.5720 Temperature regulation device for esophageal protection during cardiac ablation procedures. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Evaluation of reduction of the incidence of esophageal injury during cardiac ablation procedures; (ii) Evaluation of any effects on the ablation procedure resulting in patient injury, improper catheter performance, or interruption of procedure; and (iii) Evaluation of any esophageal or oral injury from use of the device. (2) Animal performance testing must demonstrate that the device performs as intended under the anticipated conditions of use, including evaluation of any esophageal injury from use of the device. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: (i) Mechanical integrity testing using clinically relevant forces; (ii) Testing to determine temperature change rate(s); and (iii) Compatibility testing with accessory devices. (4) Performance data must demonstrate the sterility of any device components intended to be provided sterile. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the identified shelf life. (7) Labeling must include the following: (8) A summary of clinical performance testing with the device; and (9) A shelf life. [91 FR 57502, Sept. 10, 2026] § 870.5800 Compressible limb sleeve. (a) Identification. (b) Classification. § 870.5900 Thermal regulating system. (a) Identification. (b) Classification. § 870.5910 Esophageal thermal regulation device. (a) Identification. (b) Classification. (1) The patient contacting materials must be demonstrated to be biocompatible. (2) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical integrity testing. (ii) Testing to determine temperature change rate(s). (iii) Testing to demonstrate compatibility with the indicated external controller. (iv) Shelf life testing. (3) Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use. (4) Labeling must include the following: (i) Detailed insertion instructions. (ii) Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction. (iii) The operating parameters, name, and model number of the indicated external controller. (iv) The intended duration of use. [80 FR 49896, Aug. 18, 2015] § 870.5925 Automatic rotating tourniquet. (a) Identification. (b) Classification.

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