PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted. Subpart A—General Provisions § 884.1 Scope. (a) This part sets forth the classification of obstetrical and gynecological 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, an obstetrical and gynecological 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 17740, May 11, 1987, as amended at 68 FR 44415, Aug. 27, 2003; 78 FR 18233, Mar. 26, 2013] § 884.3 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 17740, May 11, 1987] § 884.9 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 2319, Jan. 14, 2000] Subpart B—Obstetrical and Gynecological Diagnostic Devices § 884.1040 Viscometer for cervical mucus. (a) Identification. (b) Classification. [47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000] § 884.1050 Endocervical aspirator. (a) Identification. (b) Classification. § 884.1060 Endometrial aspirator. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (2) Labeling: (i) Indication: Only to evaluate the endometrium, and (ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and (3) The sampling component is covered within vagina. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000] § 884.1100 Endometrial brush. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (2) Labeling: (i) Indication: Only to evaluate the endometrium, and (ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and (3) Design and testing: (i) The sampling component is covered within the vagina, and (ii) For adherence of the bristles and brush head. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000] § 884.1175 Endometrial suction curette and accessories. (a) Identification. (b) Classification. § 884.1185 Endometrial washer. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Organization for Standardization's ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (2) Labeling: (i) Indication: Only to evaluate the endometrium, (ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and (iii) Warning: Do not attach to a wall or any external suction, and (3) Design and Testing: (i) The sampling component is covered within the vagina, and (ii) Intrauterine pressure should not exceed 50 millimeters of mercury. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000] § 884.1300 Uterotubal carbon dioxide insufflator and accessories. (a) Identification. (b) Classification. § 884.1425 Perineometer. (a) Identification. (b) Classification. § 884.1550 Amniotic fluid sampler (amniocentesis tray). (a) Identification. (b) Classification. [61 FR 1123, Jan. 16, 1996, as amended at 66 FR 33808, July 25, 2001] § 884.1560 Fetal blood sampler. (a) Identification. (b) Classification. § 884.1600 Transabdominal amnioscope (fetoscope) and accessories. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [45 FR 12684, Feb. 26, 1980, as amended at 51 FR 39845, Oct. 31, 1986] § 884.1630 Colposcope. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.1640 Culdoscope and accessories. (a) Identification. (b) Classification. (2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001] § 884.1660 Transcervical endoscope (amnioscope) and accessories. (a) Identification. (b) Classification. § 884.1690 Hysteroscope and accessories. (a) Identification. (b) Classification. (2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001] § 884.1700 Hysteroscopic insufflator. (a) Identification. (b) Classification. (2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001] § 884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator. (a) Identification. i.e., (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Software validation, verification, and hazard analysis must be provided. (3) Electrical equipment safety, including appropriate thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed. (4) Device components that are labeled sterile must be validated to a sterility assurance level of 10 −6 (5) Shelf-life testing that demonstrates the device packaging maintains sterility and the functionality of the device is maintained following simulated shipping and handling must be provided to support the proposed shelf life. (6) Non-clinical testing data must demonstrate the performance characteristics of the device. Detailed protocols and the test reports must be provided for each test. (i) The following tests must be performed for the resection portion of the device: (A) Mechanical testing to assess critical joint strength. (B) Device electrode temperature testing. (C) Coagulation depth testing. (D) Simulated use testing. (E) Device durability testing. (ii) The following tests must be performed for the fluid management portion of the device: (A) Mechanical testing to assess tensile strength of connections. (B) Pressure testing that demonstrates the following parameters, including accuracy of the pressure displayed; appropriate detection and response to overpressure conditions; activation of a secondary overpressure relief valve at the maximum safe level; and all accessories within the fluid path meet the pressure requirements. (C) Fluid delivery volume testing that demonstrates that the maximum fluid volume delivered is below a predefined level. (D) Flow rate testing. (E) Simulated use testing. (F) Filtration testing. (G) Blood filtration capacity testing. (H) Tissue collection capacity testing. (I) Filtrate characterization and testing that demonstrates that the continuous reintroduction of filtrate into the uterus does not pose a safety risk. (7) Clinician labeling must include: (i) Specific instructions and the clinical training needed for the safe use of the device. (ii) Appropriate warnings, precautions, and information related to overpressurization. (iii) Appropriate EMC information. (iv) An expiration date/shelf life. [82 FR 35073, July 28, 2017] § 884.1720 Gynecologic laparoscope and accessories. (a) Identification. (b) Classification. (2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001] § 884.1730 Laparoscopic insufflator. (a) Identification. (b) Classification. (2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001] Subpart C—Obstetrical and Gynecological Monitoring Devices § 884.2050 Obstetric data analyzer. (a) Identification. (b) Classification: (c) Date PMA or notice of completion of PDP is required. [65 FR 41332, July 5, 2000] § 884.2225 Obstetric-gynecologic ultrasonic imager. (a) Identification. (b) Classification. § 884.2600 Fetal cardiac monitor. (a) Identification. (b) Classification. § 884.2620 Fetal electroencephalographic monitor. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 884.2640 Fetal phonocardiographic monitor and accessories. (a) Identification. (b) Classification. § 884.2660 Fetal ultrasonic monitor and accessories. (a) Identification. (b) Classification. § 884.2675 Fetal scalp circular (spiral) electrode and applicator. (a) Identification. (b) Classification. § 884.2685 Fetal scalp clip electrode and applicator. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 884.2700 Intrauterine pressure monitor and accessories. (a) Identification. (b) Classification. § 884.2720 External uterine contraction monitor and accessories. (a) Identification. (b) Classification. § 884.2730 Home uterine activity monitor. (a) Identification. (b) Classification. [66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021] § 884.2740 Perinatal monitoring system and accessories. (a) Identification. (b) Classification. § 884.2800 Computerized Labor Monitoring System. (a) Identification. (b) Classification. [72 FR 20227, Apr. 24, 2007] § 884.2900 Fetal stethoscope. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 66 FR 38809, July 25, 2001] § 884.2960 Obstetric ultrasonic transducer and accessories. (a) Identification. (b) Classification. § 884.2980 Telethermographic system. (a) Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses Identification. (2) Classification. (b) Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses Identification. (2) Classification. (3) Date PMA or notice of completion of a PDP is required. [53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48440, Nov. 20, 1990; 66 FR 46953, Sept. 10, 2001] § 884.2982 Liquid crystal thermographic system. (a) A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for adjunctive use in diagnostic screening for detection of breast cancer or other uses Identification. (2) Classification. (b) A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses— (1) Identification. (2) Classification. (3) Date PMA or notice of completion of a PDP is required. [53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48441, Nov. 20, 1990; 66 FR 46953, Sept. 10, 2001] § 884.2990 Breast lesion documentation system. (a) Identification. (b) Classification. [68 FR 44415, Aug. 27, 2003, as amended at 84 FR 71816, Dec. 30, 2019] Subpart D—Obstetrical and Gynecological Prosthetic Devices § 884.3200 Cervical drain. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.3575 Vaginal pessary. (a) Identification. (b) Classification. § 884.3650 Fallopian tube prosthesis. (a) Identification. (b) Classification. § 884.3900 Vaginal stent. (a) Identification. (b) Classification. Subpart E—Obstetrical and Gynecological Surgical Devices § 884.4050 Gynecologic laparoscopic power morcellation containment system. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible; (2) Device components that are labeled sterile must be validated to a sterility assurance level of 10 −6 (3) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life; (4) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: (i) Demonstration of the device impermeability to tissue, cells, and fluids; (ii) Demonstration that the device allows for the insertion and withdrawal of laparoscopic instruments while maintaining pneumoperitoneum; (iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera; (iv) Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and (v) Demonstration that intended users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents; (5) Training must be developed and validated to ensure users can follow the instructions for use; and (6) Labeling must include the following: (i) A contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy; (ii) Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: Peri- or postmenopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision; (iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.” (iv) A statement limiting use of device to physicians who have completed the training program; and (v) An expiration date or shelf life. [81 FR 40183, June 21, 2016] § 884.4100 Endoscopic electrocautery and accessories. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and (iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),” (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,” (4) Labeling: (i) Indication: For female tubal sterilization, and (ii) Instructions for use: (A) Destroy at least 2 centimeters of the fallopian tubes, (B) Use a cut or undampened sinusoidal waveform, (C) Use a minimum power of 25 watts, and (D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000] § 884.4120 Gynecologic electrocautery and accessories. (a) Identification. (b) Classification. § 884.4150 Bipolar endoscopic coagulator-cutter and accessories. (a) Identification. (b) Classification. (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and (iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),” (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,” (4) Labeling: (i) Indication: For female tubal sterilization, and (ii) Instructions for use: (A) Destroy at least 2 centimeters of the fallopian tubes, (B) Use a cut or undampened sinusoidal waveform, (C) Use a minimum power of 25 watts, and (D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000] § 884.4160 Unipolar endoscopic coagulator-cutter and accessories. (a) Identification. (b) Classification. § 884.4250 Expandable cervical dilator. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 884.4260 Hygroscopic Laminaria cervical dilator. (a) Identification. Laminaria Laminaria Laminaria (b) Classification. § 884.4270 Vibratory cervical dilators. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 884.4340 Fetal vacuum extractor. (a) Identification. (b) Classification. § 884.4350 Fetal head elevator. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of 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 identified shelf life. (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted. (ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted. (iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted. (5) Labeling must include the following: (i) Contraindication for use in the presence of active genital infection; (ii) Specific instructions regarding the proper placement and use of the device; and (iii) A shelf life. [82 FR 60114, Dec. 19, 2017] § 884.4400 Obstetric forceps. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.4500 Obstetric fetal destructive instrument. (a) Identification. (b) Classification. § 884.4520 Obstetric-gynecologic general manual instrument. (a) Identification. (1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes. (2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina. (3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina. (4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord. (5) A uterine clamp is an instrument used to hold the uterus by compression. (6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina. (7) A vaginal applicator is an instrument used to insert medication into the vagina. (8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue. (9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid. (10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001] § 884.4530 Obstetric-gynecologic specialized manual instrument. (a) Identification. (1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina. (b) Classification. (2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, Dec. 30, 2019] § 884.4550 Gynecologic surgical laser. (a) Identification. (b) Classification. § 884.4900 Obstetric table and accessories. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh. (a) Identification. (b) Classification. (1) The device must be demonstrated to be biocompatible; (2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed; (3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life; (4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and (5) Labeling must include: (i) Information regarding the mesh design that may be used with the device; (ii) Detailed summary of the clinical evaluations pertinent to use of the device; (iii) Expiration date; and (iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components. [82 FR 1603, Jan. 6, 2017] Subpart F—Obstetrical and Gynecological Therapeutic Devices § 884.5050 Metreurynter-balloon abortion system. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, 1996] § 884.5070 Vacuum abortion system. (a) Identification. (b) Classification. § 884.5100 Obstetric anesthesia set. (a) Identification. (b) Classification. § 884.5150 Nonpowered breast pump. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001] § 884.5160 Powered breast pump. (a) Identification. (b) Classification. § 884.5200 Hemorrhoid prevention pressure wedge. (a) Identification. (b) Classification. (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) The labeling must include specific instructions regarding the proper placement and use of the device. (3) The device must be demonstrated to be biocompatible. (4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use. (5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls. [76 FR 21238, Apr. 15, 2011, as amended at 84 FR 71816, Dec. 30, 2019] § 884.5210 Pressure wedge for the reduction of cesarean delivery. (a) Identification. (b) Classification. (1) The patient contacting materials must be evaluated to be biocompatible. (2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor. (3) Performance data must validate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life. (5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma. (6) The labeling must include: (i) Specific instructions regarding the proper placement and use of the device. (ii) A shelf life. [82 FR 61448, Dec. 28, 2017] § 884.5225 Abdominal decompression chamber. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, 1996] § 884.5250 Cervical cap. (a) Identification. (b) Classification. § 884.5300 Condom. (a) Identification. (b) Classification. (2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document. [73 FR 66538, Nov. 10, 2008] § 884.5305 External condom for anal intercourse or vaginal intercourse. (a) Identification. (b) Classification. (1) Clinical performance data must demonstrate the total rate of clinical failure and rate of individual failure modes of the device based on an acute failure modes study. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The data must include an assessment of mechanical and material integrity, including an evaluation of device failure modes. For devices made of materials other than natural rubber latex, viral penetration testing must be conducted to evaluate barrier effectiveness to sexually transmitted infections. (3) The device must be demonstrated to be biocompatible. (4) Performance data must support the shelf life of the device by demonstrating device functionality and package integrity over the identified shelf life. (5) Labeling must include: (i) If indicated for vaginal intercourse, a contraceptive effectiveness table comparing typical use and perfect use pregnancy rates with the device to other available methods of birth control; (ii) Statement regarding compatibility with additional lubricant types; (iii) Statement regarding the adverse events associated with the device, including transmission of infection, pregnancy, adverse tissue reaction, mechanical injury, or improper device use; (iv) Expiration date; and (v) The following information, warnings and precautions: (A) The sexually transmitted infections (STIs) for which the device is most protective, the degree of protection the device provides against specific types of STIs, and the STIs the device does not protect against; (B) A statement that the device does not completely eliminate the risks of pregnancy and sexually transmitted infections and that risk can be decreased with correct and consistent use; (C) A warning regarding the risk of device failure during anal intercourse if adequate lubricant is not used; (D) A warning stating that the device cannot be used multiple times and is limited to one sex act; and (E) A precaution stating not to use the device if the user is at risk for material related allergic reactions. [91 FR 25111, May 8, 2026] § 884.5310 Condom with spermicidal lubricant. (a) Identification. (b) Classification. [47 FR 49022, Oct. 29, 1982] § 884.5320 Glans sheath. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [59 FR 67187, Dec. 29, 1994, as amended at 67 FR 40849, June 14, 2002] § 884.5330 Multiple-use female condom. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [65 FR 31455, May 18, 2000, as amended at 76 FR 50667, Aug. 16, 2011; 83 FR 48714, Sept. 27, 2018] § 884.5340 Single-use internal condom. (a) Identification. (b) Classification. (1) Clinical performance testing must evaluate the following: (i) Rate of clinical failure of the device and rate of individual failure modes of the device based on an acute failure modes study evaluating the intended use (vaginal and/or anal intercourse); and (ii) Cumulative pregnancy rate when using the device based on a contraceptive effectiveness study (when the device is indicated for vaginal intercourse). (2) Viral penetration testing must demonstrate the device is an effective barrier to sexually transmitted infections. (3) Nonclinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Mechanical testing must demonstrate the device can withstand forces under anticipated use conditions, include evaluation of tensile, tear, and burst properties of the device; and (ii) Compatibility testing with personal lubricants must determine whether the physical properties of the device are adversely affected by use of additional lubricants. (4) The device must be demonstrated to be biocompatible. (5) Shelf-life testing must demonstrate that the device maintains its performance characteristics and the packaging of the device must maintain integrity for the duration of the shelf-life. (6) Labeling of the device must include: (i) Contraceptive effectiveness table comparing typical use and perfect use pregnancy rates with the device to other available methods of birth control; (ii) Statement regarding the adverse events associated with the device, including potential transmission of infection, adverse tissue reaction, and ulceration or other physical trauma; (iii) Expiration date; and (iv) Statement regarding compatibility with additional types of personal lubricants. [83 FR 48714, Sept. 27, 2018] § 884.5350 Contraceptive diaphragm and accessories. (a) Identification. (b) Classification. § 884.5360 Contraceptive intrauterine device (IUD) and introducer. (a) Identification. (b) Classification. (c) [Reserved] (d) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [45 FR 12684, Feb. 26, 1980, as amended at 51 FR 16649, May 5, 1986; 85 FR 18443, Apr. 2, 2020] § 884.5370 Software application for contraception. (a) Identification. e.g., (b) Classification. (1) Clinical performance testing must demonstrate the contraceptive effectiveness of the software in the intended use population. (2) Human factors performance evaluation must be provided to demonstrate that the intended users can self-identify that they are in the intended use population and can correctly use the application, based solely on reading the directions for use for contraception. (3) Software verification, validation, and hazard analysis must be performed. Documentation must include the following: (i) A cybersecurity vulnerability and management process to assure software functionality; and (ii) A description of the technical parameters of the software, including the algorithm used to determine fertility status and alerts for user inputs outside of expected ranges. (4) Labeling must include: (i) The following warnings and precautions: (A) A statement that no contraceptive method is 100% effective. (B) A statement that another form of contraception (or abstinence) must be used on days specified by the application. (C) Statements of any factors that may affect the accuracy of the contraceptive information. (D) A warning that the application cannot protect against sexually transmitted infections. (ii) Hardware platform and operating system requirements. (iii) Instructions identifying and explaining how to use the software application, including required user inputs and how to interpret the application outputs. (iv) A summary of the clinical validation study and results, including effectiveness of the application as a stand-alone contraceptive and how this effectiveness compares to other forms of legally marketed contraceptives. [84 FR 7995, Mar. 6, 2019] § 884.5380 Contraceptive tubal occlusion device (TOD) and introducer. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 36883, Oct. 1, 1987] § 884.5390 Perineal heater. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.5400 Menstrual cup. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.5425 Scented or scented deodorized menstrual pad. (a) Identification. (b) Classification. (2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51185, Aug. 1, 1980; 61 FR 67714, Dec. 24, 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, Dec. 30, 2019] § 884.5435 Unscented menstrual pad. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 1996; 65 FR 2320, Jan. 14, 2000; 73 FR 34860, June 19, 2008; 84 FR 71816, Dec. 30, 2019] § 884.5460 Scented or scented deodorized menstrual tampon. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51186, Aug. 1, 1980] § 884.5470 Unscented menstrual tampon. (a) Identification. (b) Classification. § 884.5900 Therapeutic vaginal douche apparatus. (a) Identification. (b) Classification. (2) Class I if the device is operated by gravity feed. Devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001] § 884.5920 Vaginal insufflator. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001] § 884.5940 Powered vaginal muscle stimulator for therapeutic use. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 19834, Apr. 13, 2000] § 884.5960 Genital vibrator for therapeutic use. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 83 FR 29215, June 5, 2018] § 884.5970 Clitoral engorgement device. (a) Identification. (b) Classification. [65 FR 47306, Aug. 2, 2000] § 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair. (a) Identification. (b) Classification. (c) Date premarket application approval or notice of completion of a product development protocol is required. [81 FR 361, Jan. 5, 2016, as amended at 81 FR 369, Jan. 5, 2016] Subpart G—Assisted Reproduction Devices Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted. § 884.6100 Assisted reproduction needles. (a) Identification. (b) Classification. § 884.6110 Assisted reproduction catheters. (a) Identification. (b) Classification. § 884.6120 Assisted reproduction accessories. (a) Identification. (1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures. (3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation. (4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature. (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019; 85 FR 44188, July 22, 2020] § 884.6130 Assisted reproduction microtools. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.6140 Assisted reproduction micropipette fabrication instruments. (a) Identification. (b) Classification. § 884.6150 Assisted reproduction micromanipulators and microinjectors. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.6160 Assisted reproduction labware. (a) Identification. (b) Classification. [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] § 884.6165 Intravaginal culture system. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate the following: (i) Comfort and retention of the intravaginal culture device; (ii) Adverse vaginal tissue reactions associated with intravaginal culture; (iii) Maximum number of gametes and/or embryos that can be placed in a device; and (iv) Rates of embryo development to the designated stage, implantation rates, clinical pregnancy rates, live birth rates, and any adverse events or outcomes. (2) Nonclinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Mouse embryo assay testing to assess embryotoxicity by evaluating the gamete and embryo-contacting device components effect on the growth and development of mouse embryos to the blastocyst stage; (ii) Endotoxin testing on gamete and embryo-contacting components of the device; (iii) Cleaning and disinfection validation of reusable device components; (iv) Sterility maintenance of the culture media within the device throughout the vaginal incubation period and subsequent embryo extraction; and (v) Ability of the device to permit oxygen and carbon dioxide exchange between the media contained within the device and the external environment throughout the vaginal incubation period. (3) The 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) Shelf life testing must demonstrate that the device maintains its performance characteristics and the packaging of device components labeled as sterile maintain integrity and sterility for the duration of the shelf life. (6) Labeling for the device must include: (i) A detailed summary of the clinical testing, including device effectiveness, device-related complications, and adverse events; (ii) Validated methods and instructions for reprocessing of reusable components; (iii) The maximum number of gametes or embryos that can be loaded into the device; (iv) A warning that informs users that the embryo development is first evaluated following intravaginal culture; and (v) A statement that instructs the user to use legally marketed assisted reproductive technology media that contain elements to mitigate the contamination risk ( e.g., (7) Patient labeling must be provided and must include: (i) Relevant warnings, precautions, and adverse effects and complications; (ii) Information on how to use the device; (iii) The risks and benefits associated with the use of the device; and (iv) A summary of the principal clinical device effectiveness results. [81 FR 379, Jan. 6, 2016] § 884.6170 Assisted reproduction water and water purification systems. (a) Identification. (b) Classification. § 884.6180 Reproductive media and supplements. (a) Identification. (b) Classification. [63 FR 48436, Sept. 10, 1998, as amended at 85 FR 44188, July 22, 2020] § 884.6190 Assisted reproductive microscopes and microscope accessories. (a) Identification. (b) Classification. [63 FR 48436, Sept. 10, 1998, as amended at 64 FR 62977, Nov. 18, 1999; 66 FR 38809, July 25, 2001] § 884.6195 Assisted Reproduction Embryo Image Assessment System. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate a reasonable assurance of safety and effectiveness of the device to predict embryo development. Classification performance (sensitivity and specificity) and predictive accuracy (Positive Predictive Value and Negative Predictive Value) must be assessed at the subject and embryo levels. (2) Software validation, verification, and hazard analysis must be provided. (3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: (i) Total light exposure and output testing; (ii) A safety analysis must be performed based on maximum (worst-case) light exposure to embryos, which also includes the safety of the light wavelength(s) emitted by the device; (iii) Simulated-use testing; (iv) Mouse Embryo Assay testing to assess whether device operation impacts growth and development of mouse embryos to the blastocyst stage; (v) Cleaning and disinfection validation of reusable components; (vi) Package integrity and transit testing; (vii) Hardware fail-safe validation; (viii) Electrical equipment safety and electromagnetic compatibility testing; and (ix) Prediction algorithm reproducibility. (4) Labeling must include the following: (i) A detailed summary of clinical performance testing, including any adverse events; (ii) Specific instructions, warnings, precautions, and training needed for safe use of the device (iii) Appropriate electromagnetic compatibility information; (iv) Validated methods and instructions for cleaning and disinfection of reusable components; and (v) Information identifying compatible cultureware and explain how they are used with the device. [80 FR 10332, Feb. 26, 2015] § 884.6200 Assisted reproduction laser system. (a) Identification. (b) Classification. [69 FR 77624, Dec. 28, 2004]