(299 days)
VagiVital Aktivgel is a personal lubricant for 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 polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
VagiVital Aktivgel is a water-based personal lubricant containing water, hypromellose, benzoic acid, lactic acid, and sodium hydroxide. VagiVital Aktivgel is provided in a 36 ml aluminum tube and may be packaged together with a reusable applicator.
The provided text describes the predicate device information and a summary of performance data for the VagiVital Aktivgel (K200098), which is a personal lubricant. It does not describe an AI/ML medical device. Therefore, I cannot extract information related to acceptance criteria for an AI device.
However, I can extract the acceptance criteria and study data relevant to the performance of this non-AI medical device.
Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (as demonstrated by studies) |
|---|---|---|
| Appearance/Color | Clear gel with fine visible particles | Maintained over 24-month shelf-life |
| Odor | Odorless | Maintained over 24-month shelf-life |
| pH | 3.6-4.0 | Maintained over 24-month shelf-life |
| Viscosity per USP | 13800-75000 s | Maintained over 24-month shelf-life |
| Osmolality per USP | 32-150 mOsmol/kg | Maintained over 24-month shelf-life |
| Antimicrobial Effectiveness per USP | Category 2 per USP | Maintained over 24-month shelf-life |
| Total Microbial Count per USP | (Pseudomonas aeruginosa, Staphylococcus aureous, Candida albicans) | |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic | Demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic |
| Condom Compatibility | Compatible with polyisoprene condoms | Determined to be compatible with polyisoprene condoms |
| Shelf-life | 24 months | Demonstrated to maintain specifications for 24 months (accelerated aging and real-time stability study) |
As this device is not an AI/ML medical device, the following points are not applicable and therefore cannot be extracted from the provided text:
- Sample sized used for the test set and the data provenance: Not applicable for a chemical product. Performance testing focused on physical, chemical, and biological properties, not a "test set" of data for algorithm evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a personal lubricant's properties is established by laboratory testing against scientific standards, not expert consensus on image/data interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this non-AI device, the "ground truth" for its properties (pH, viscosity, biocompatibility, etc.) is established through standardized laboratory testing and analytical chemistry methods as per USP and ISO standards, not expert consensus or pathology.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.