(54 days)
Personal Lubricating Liquid is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
Lubricating Liquid is a water-based, nonsticky. Personal nonstaining personal lubricant that is compatible with condoms and diagrams.
The provided 510(k) summary for K973780, "Personal Lubricating Liquid," describes a comparison study against a predicate device, KY Liquid (K790087). However, it does not provide acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy), nor does it detail a study that would typically be associated with such criteria for a diagnostic or AI device.
This submission is for a medical device that is a personal lubricant, not an AI or diagnostic device. Therefore, the questions related to clinical performance, ground truth, experts, and AI-specific metrics are not applicable to the information provided.
Based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Stability: Successfully pass accelerated stability protocol requirements. | Passed: Successfully met the requirements of Qualis, Inc., accelerated stability protocol, assigned a two-year expiration period. |
| Preservative Effectiveness: Successfully pass antimicrobial preservative challenge. | Passed: Successfully met the requirements of Qualis, Inc., antimicrobial preservative challenge. |
| Comparison with Predicate Device (Perceptual Qualities, Physical/Chemical Properties, Ingredients, Label Claims, Packaging): Result in a "Good" comparison. | Achieved: "Good" comparison with KY Liquid based on the specified criteria. |
2. Sample size used for the test set and the data provenance: Not applicable. The study involved a comparison of properties and qualities, not a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established through laboratory testing and comparative analysis of product attributes.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication was 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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For stability and preservative effectiveness, the ground truth was based on established laboratory protocols and industry standards for product quality and safety. For the comparison with the predicate device, it was based on an assessment of perceptual qualities, physical and chemical properties, ingredient list review, label claims, and packaging of both products.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of device submission.
9. 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.