(209 days)
Use Lubricating Jelly to lubricate condoms and for personal lubrication when vaginal dryness causes discomfort. It also eases insertion of rectal thermometers, enemas, and tampons.
The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone. glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
Here's a breakdown of the acceptance criteria and study information for the San-Mar Laboratories Lubricating Jelly, based on the provided document:
This device (San-Mar Laboratories Lubricating Jelly) is a Class II medical device, and the documentation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, many of the requested fields related to a clinical or AI-driven performance study are not applicable or cannot be extracted from this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Stability | Labeled shelf life (36 months) maintained. | Demonstrated stability throughout the 36-month labeled shelf life. |
| Preservative Effectiveness | Compliance with USP method . | Demonstrated compliance with USP method . |
| Technological Characteristics | Identical to K-Y® Lubricating Jelly (predicate). | Stated as "identical to those of the predicate device." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This 510(k) summary does not describe a test set or data provenance for a performance study in the way it would for a diagnostic or AI-driven device. The "study" mentioned is a long-term stability study and a preservative effectiveness test, not a clinical performance trial with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document does not pertain to a study involving expert-established ground truth for a test set.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication method is described.
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 personal lubricant, not an AI-driven diagnostic or image analysis tool, so an MRMC study is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used
- Not Applicable in the traditional sense. For the stability and preservative effectiveness tests, the "ground truth" would be the pre-defined specifications for stability over time and the microbial kill rates/preservation efficacy against specific challenge organisms as per USP . These are objective chemical and microbiological measurements, not expert consensus or pathology.
8. The sample size for the training set
- Not Applicable. This document does not describe a training set as it would for a machine learning or AI device. The "study" focused on product samples for stability and preservative testing.
9. How the ground truth for the training set was established
- Not Applicable. No training set is described.
Summary of the Study:
The primary study mentioned in this 510(k) summary is a 36-month long-term stability study and a preservative effectiveness test (in accordance with USP method ). These studies were conducted to confirm the labeled shelf life and the efficacy of the preservatives in the San-Mar Labs Lubricating Jelly. The results confirmed the stability throughout the 36-month shelf life and compliance with USP method . The core evidence for this 510(k) relies on demonstrating that the device's technological characteristics are identical to the predicate device (K-Y® Lubricating Jelly) and that it meets basic quality and shelf-life requirements.
§ 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.