(45 days)
The Clay-Park Labs Lubricating Jelly is intended for personal lubrication when vaginal dryness causes discomfort and as a lubricant for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.
The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle of glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
This document is a 510(k) summary for the Clay-Park Labs Lubricating Jelly, a patient lubricant. It focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria and a study proving performance against those criteria in the way one would for a diagnostic or AI-powered medical device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safe for intended use. | Confirmed through substantial equivalence to a legally marketed predicate device (K-Y® Lubricating Jelly). |
| Effectiveness/Performance: Device performs as intended. | Confirmed through substantial equivalence to a legally marketed predicate device (K-Y® Lubricating Jelly). |
| Stability: Device maintains properties over shelf-life. | Stability confirmed for 36 months via long-term stability study and preservative effectiveness test (USP method ). |
| Technological Characteristics: Comparable to predicate. | "The technological characteristics of the Clay-Park Labs Lubricating Jelly are identical to those of the predicate device." |
| Intended Use: Matches predicate device. | Identical intended use as the predicate device (personal lubrication for vaginal dryness, insertion of medical devices). |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance data (stability testing), not a challenge set performance evaluation. The "test set" in this context would refer to samples used in the stability study.
- Data provenance: Not specified beyond the company's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of device performance (stability, formulation) is established through analytical testing and adherence to recognized standards like USP , not expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" requiring adjudication in the sense of expert review or consensus.
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:
- Not applicable. This device is a manual medical lubricant, not an diagnostic or AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual medical lubricant, not an algorithm.
7. The type of ground truth used:
- For stability and preservative effectiveness: Analytical testing results against predetermined specifications and USP method standards.
- For substantial equivalence: Comparative analysis of technological characteristics and intended use against the predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/algorithm-based device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The primary "study" supporting the Clay-Park Labs Lubricating Jelly's performance and safety is the demonstration of substantial equivalence to the K-Y® Lubricating Jelly predicate device, combined with a **36-month long-term stability study and a preservative effectiveness test in accordance with USP method **.
- Substantial Equivalence: The submission asserts that the technological characteristics of the Clay-Park Labs Lubricating Jelly are "identical to those of the predicate device" (K-Y® Lubricating Jelly) and that its intended use is also the same. This implies that since the predicate device is legally marketed and generally accepted as safe and effective for its intended use, a device with identical characteristics and intended use is also considered safe and effective.
- Stability and Preservative Effectiveness: A 36-month long-term stability study was conducted to confirm the product's stability throughout its labeled shelf-life. Concurrently, a preservative effectiveness test, performed according to United States Pharmacopeia (USP) method , confirmed that the preservatives (chlorhexidine gluconate and methylparaben) were effective in inhibiting microbial growth over time. These tests are critical in ensuring the product maintains its properties and remains safe for use over its shelf-life.
§ 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.