(30 days)
The device is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber and polyisoprene condoms. Not compatible with polyurethane condoms.
Vaginal Moisturizing Gel is a non-sterile, water based, colorless, transparent viscous gel. It is identical to the predicate devices except that it is packaged for use in tube sizes of either 5 or 50 grams (0.18oz. /1.8 oz.). Tubes are comprised of a laminate structure. The larger 50 gram size will utilize a flip-top cap while the smaller 5 gram size will utilize a screw on cap.
This device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. The following parameters are included as part of the device specification:
- Appearance
- Color
- Odor
- pH
- Viscosity
- Osmolality
- Antimicrobial effectiveness
- Total Aerobic Microbial Count (TAMC)
- Total Yeast and Mold Count (TYMC)
- Absence of Pathogenic Organisms (at minimum Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans)
The provided text describes a 510(k) premarket notification for a Vaginal Moisturizing Gel. This is a medical device submission, and the content focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a diagnostic or AI-powered device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, how ground truth for training was established) are not applicable to this type of submission or the information provided.
However, I can extract the acceptance criteria and reported device performance from the "Physical/Chemical" and "Micro" sections, as these represent the specifications the device must meet.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "reported device performance" in the sense of a measured outcome from a study for each parameter. Instead, it lists the "Acceptance range" or "Acceptance criteria" for various characteristics, which the device is asserted to meet. The accompanying statements about "Conclusion" and "Performance Testing" imply that the device does meet these criteria.
| Characteristic | Acceptance Criterion | Reported Device Performance (Assumed to meet criteria) |
|---|---|---|
| Physical/Chemical | ||
| Appearance | Clear translucent | Clear translucent |
| pH | 4.0 - 5.0 | 4.0 - 5.0 |
| Viscosity | 55,000 - 100,000 cps | 55,000 - 100,000 cps |
| Osmolality (mOsm/kg) | 1273 ± 9 | 1273 ± 9 |
| Micro | ||
| Total plate count |
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(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.