(337 days)
K-Y® Brand Vaginal Moisturizer 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 or synthetic condoms.
K-Y® Brand Vaginal Moisturizer is a non-sterile personal moisturizer formulated to supplement the body's own natural lubricating fluids to provide personal moisturization when vaginal dryness causes discomfort. K-Y® Brand Vaginal Moisturizer, is a stable, non-sterile, translucent, aqueous based, preserved, formulated product composed of a combination of emollients, gelling agents, preservatives, vehicles, and an antioxidant. It is non-fragranced, pH balanced, and contains Vitamin E. The proposed device is packaged in pre-filled applicators to facilitate insertion directly into the vagina.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the K-Y® Brand Vaginal Moisturizer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Lubricity | Comparable to the predicate device (K-Y® Brand Jelly Personal Lubricant). |
| Stability | 2-year shelf life confirmed by real-time stability data. |
| Condom Compatibility | Not compatible with condoms. Labeling will include a warning statement. |
| Biocompatibility (Cytotoxicity) | Agar Overlay Cytotoxicity testing performed on the current device. |
| Biocompatibility (Vaginal Irritation) | Rabbit Vaginal Irritation testing performed on a prototype formula. |
| Human Safety (Exaggerated Use) | Exaggerated Human Use (Human Repeat Insult Patch Test) performed. |
| Human Safety (In-Home Use) | In-Home Consumer Use Study performed. |
Study Details:
This document is a 510(k) summary for a medical device (K-Y® Brand Vaginal Moisturizer) seeking substantial equivalence to a predicate device. It describes the performed tests to demonstrate the device's safety and effectiveness. It's crucial to understand that this document primarily focuses on demonstrating substantial equivalence, not conducting a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as these are not relevant for this type of product and regulatory filing.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for each test listed (e.g., Agar Overlay Cytotoxicity, Rabbit Vaginal Irritation, Human Repeat Insult Patch Test, In-Home Consumer Use Study). It only mentions that these tests were "performed."
- Data Provenance: The studies were conducted by the applicant, Johnson & Johnson Healthcare Products. The location of the studies (e.g., country of origin) is not specified, but the applicant's address is in Morris Plains, NJ, USA. The studies would be considered prospective as they were conducted specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a personal lubricant, not an diagnostic imaging or AI-driven decision support system that requires expert interpretation for ground truth establishment. The "ground truth" here is determined by direct laboratory tests and human safety assessments.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies and establish a consensus "ground truth." This is not relevant for the types of tests described for a vaginal moisturizer.
5. 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging systems where human readers interpret data with and without AI assistance. K-Y® Brand Vaginal Moisturizer is a physical product (lubricant), not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms. K-Y® Brand Vaginal Moisturizer is a physical product.
7. The type of ground truth used
The "ground truth" for this product is established through:
- Laboratory Testing: For factors like lubricity, stability, and condom compatibility.
- Biocompatibility Testing:
- Agar Overlay Cytotoxicity (in vitro lab test).
- Rabbit Vaginal Irritation (in vivo animal model).
- Human Safety Studies:
- Exaggerated Human Use (Human Repeat Insult Patch Test) – direct observation of human skin reactions.
- In-Home Consumer Use Study – direct user feedback on safety and performance.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of product.
§ 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.