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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- HDOValve, Tubal Occlusion3Product Code
- HDRCap, Cervical2Product Code
- HDTDevice, Intrauterine, Contraceptive And Introducer3Product Code
- HDWDiaphragm, Contraceptive (And Accessories)2Product Code
- HEBTampon, Menstrual, Unscented2Product Code
- HECInsufflator, Vaginal1Product Code
- HEDDouche Apparatus, Vaginal, Therapeutic1Product Code
- HEESet, Anesthesia, Paracervical2Product Code
- HEGSet, Anesthesia, Pudendal2Product Code
- HEHChamber, Decompression, Abdominal3Product Code
- HFYBand, Tubal Occlusion3Product Code
- HGBClip, Tubal Occlusion3Product Code
- HGFSource, Abortion Unit, Vacuum2Product Code
- HGGController, Abortion Unit, Vacuum2Product Code
- HGHCannula, Suction, Uterine2Product Code
- HGXPump, Breast, Powered2Product Code
- HGYPump, Breast, Non-Powered1Product Code
- HGZHeater, Perineal, Direct Contact2Product Code
- HHAHeater, Perineal, Radiant, Non-Contact2Product Code
- HHDPad, Menstrual, Unscented1Product Code
- HHECup, Menstrual2Product Code
- HHISystem, Abortion, Vacuum2Product Code
- HHLPad, Menstrual, Scented2Product Code
- HHQSystem, Abortion, Metreurynter-Balloon3Product Code
- HHSTranscervical Contraceptive Tubal Occlusion Device3Product Code
- HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic Use3Product Code
- HILTampon, Menstrual, Scented, Deodorized2Product Code
- HISCondom2Product Code
- KNDHeater, Perineal2Product Code
- KNESet, Anesthesia, Obstetric2Product Code
- KNHLaparoscopic Contraceptive Tubal Occlusion Device3Product Code
- KXQVibrator For Therapeutic Use, Genital2Product Code
- LTZCondom With Nonoxynol-92Product Code
- LZLMicro-Condom3Product Code
- MBUSingle-Use Internal Condom2Product Code
- MFDCannula, Intrauterine Insemination2Product Code
- NURPad, Interlabial1Product Code
- MOLCondom, Synthetic2Product Code
- MSCBarrier, Std, Oral Sex2Product Code
- NBVDevice, Engorgement, Clitoral2Product Code
- NRCPads, Menstrual, Scented-Deodorized1Product Code
- NUCLubricant, Personal2Product Code
- NUQPad, Menstrual, Reusable1Product Code
- OBBKit, Conception-Assist, Home Use2Product Code
- OBYCondom, Female, Animal Tissue3Product Code
- PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible2Product Code
- OHHBreast Pump Kit2Product Code
- OKWSeminal Fluid Collection Kit2Product Code
- OOAHemorrhoid Prevention Pressure Wedge2Product Code
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PAIMesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery2Product Code
- PVTMaternity Kit1Product Code
- PVUObstetrical Anesthesia Kit2Product Code
- PVVParacervical Anesthesia Kit2Product Code
- PVWPudendal Anesthesia Kit2Product Code
- PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure1Product Code
- PYTDevice, Fertility Diagnostic, Contraceptive, Software Application2Product Code
- QPDPersonal Lubricant Ring2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
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Single-Use Internal Condom
- Page Type
- Product Code
- Definition
- For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.
- Physical State
- A single-use internal condom is a sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus.
- Technical Method
- The device is inserted into the vagina or anus.
- Target Area
- Vagina or anus
- Regulation Medical Specialty
- Obstetrical and Gynecological
- Review Panel
- Obstetrical and Gynecological
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 884.5340
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 884.5340 Single-use internal condom
§ 884.5340 Single-use internal condom.
(a) Identification. A single-use internal condom is an over-the-counter sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus. At the conclusion of coitus, it is removed and discarded. It is indicated for contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes.
(b) Classification. Class II (special controls). The special controls for this device are:
(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]