(25 days)
The intended use of this device is as a personal lubricant compatible with latex condom.
K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with latex condom.
This device is a condom compatible personal lubricant that has been specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
Device: K-Y® Brand Warming Liquid (Personal Lubricant)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| Condom compatibility | "The proposed device is compatible with the leading commercial brands of latex condoms." |
| Lubricity | "Lubricity of the proposed device is comparable to the lubricity of predicate device." |
| Safety (Ingredients) | "The ingredients used in the formulation... are generally recognized as safe (GRAS) and the pre-clinical evaluation... has determined that they are safe for use in personal lubricant products." |
| Warming claim | "The consumer use test has shown that the product meets its warming claim." |
| Non-sensitizing | "The human RIPT shows that the proposed device is non-sensitizing." |
| Overall substantial equivalence | "The proposed device is substantially equivalent to the currently marketed products in technology, intended use, safety, and suitability characteristics." |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the "test set" in terms of specific numbers of condoms, consumers for the use test, or participants for the RIPT.
- Condom Compatibility: Tested with "leading commercial brands of latex condoms." (No specific number mentioned). Data provenance is from "laboratory testing."
- Lubricity: Compared to the "predicate device." Data provenance is from "laboratory testing."
- Warming Claim: Assessed via a "consumer use test." Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but "consumer use test" typically implies prospective.
- Non-sensitizing: Assessed via "human RIPT" (Repeat Insult Patch Test). Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but an RIPT is a prospective clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical device evaluation (e.g., radiologists interpreting images). The evaluations are based on:
- Laboratory testing for physical properties (condom compatibility, lubricity).
- Pre-clinical evaluations for ingredient safety.
- Consumer self-reporting for the warming claim (implied from "consumer use test").
- Medical/Toxicological experts for interpreting RIPT results (implied by "human RIPT shows that the proposed device is non-sensitizing," but no specific number or qualifications are provided).
4. Adjudication Method for the Test Set:
No specific adjudication method (like 2+1 or 3+1) is described for any of the tests. The results seem to be direct outcomes of laboratory measurements, pre-clinical assessments, and consumer feedback/RIPT results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple human readers evaluate cases with and without AI assistance to measure improvement in diagnostic performance. The K-Y® Brand Warming Liquid is a personal lubricant, not a diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is not an algorithm or AI-driven system. The "performance data" refers to the physical and biological characteristics of the lubricant itself.
7. The Type of Ground Truth Used:
The "ground truth" for this device's evaluation is based on a combination of:
- Objective Laboratory Data: For condom compatibility and lubricity.
- Pre-clinical Safety Data: For ingredient safety.
- Subjective Human Perception/Response: For the warming claim (consumer use test) and non-sensitization (RIPT, which has objective endpoints but measures a biological response in humans).
- Comparison to Predicate Device: Many of the claims are based on "comparable" or "equivalent" performance to legally marketed predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of an AI/ML algorithm. The product formulation and testing are based on traditional chemical and biological safety/efficacy assessments.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an algorithm.
§ 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.