(261 days)
Vagisan® Moisturizing Cream 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 not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
Vagisan Moisturizing Cream is a non-sterile, water-based, white, non-irritating, non-greasy, non-staining vaginal cream delivered in a tube with a reusable applicator or sachet (sample size) as a long-lasting moisturizer for vaginal dryness.
The provided text details the 510(k) premarket notification for Vagisan® Moisturizing Cream, a personal lubricant. It does not describe an AI/ML device or its performance criteria, but rather a medical device (a cream) and its studies to prove substantial equivalence to a predicate device.
Therefore, most of the requested information (like AI/ML specific acceptance criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth for AI) is not applicable to the provided document.
However, I can extract information related to the performance studies conducted for the Vagisan® Moisturizing Cream as a medical device.
Acceptance Criteria and Device Performance (Based on provided studies for device safety and tolerability, not AI/ML performance):
| Acceptance Criteria (Study Endpoint) | Reported Device Performance (Vagisan® Moisturizing Cream) |
|---|---|
| Human Repeat Insult Patch Test (HRIPT): | |
| Non-irritating and non-sensitizing on skin | 104 out of 106 subjects (98%) showed no signs or symptoms of cutaneous irritation, demonstrating non-irritating and non-sensitizing properties. |
| Prospective, Multicenter, Controlled, Randomized Study: | |
| Tolerability assessed as "very good" or "good" by subjects and physicians. | 93% of study subjects assessed tolerability as "very good" or "good." |
| 100% of physicians assessed tolerability as "very good" or "good." | |
| Non-irritating and non-sensitizing on vaginal mucosa (implied by tolerability) | Demonstrated non-irritating and non-sensitizing properties in the vaginal area. |
| Prospective, Non-randomized, Non-controlled Study (Breast Cancer Patients): | |
| Tolerability assessed as "very good" or "good" by subjects and physicians. | 90% of study subjects assessed tolerability as "very good" or "good." |
| 91% of physicians assessed tolerability as "very good" or "good." | |
| Cytotoxicity Testing (ISO 10993-5:2009): | |
| Acceptable cytotoxicity profile given intended use | Showed a concentration-dependent cytotoxic effect (not uncommon for neat lubricants), but considered acceptable given better performance than some cleared lubricants and clinical study results. |
| Toxicological Risk Assessment: | |
| Ingredients within tolerable exposure values | Total amount of each ingredient less than tolerable exposure values obtained from literature review. |
| Stability Testing: | |
| Maintains specifications over stated shelf-life | Maintains specifications over 24 months. |
Since this is not an AI/ML device, the following points are not applicable and cannot be answered based on the provided text:
- Sample size used for the test set and the data provenance: Not an AI/ML test set. Clinical study sample sizes are given in the table above (106, 117, 117 subjects). Data provenance is human subjects from studies, implied to be prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Clinical observations by physicians and self-assessments by subjects served as data points.
- 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.): Ground truth for the medical device's safety and tolerability was established through clinical observations by physicians, self-reported symptoms by subjects, and laboratory testing (e.g., cytotoxicity, analytical chemistry).
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable (no AI/ML training set).
§ 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.