(90 days)
Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.
K-Y® Brand Ultra Gel™ is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for lubrication, and moisturization purposes. It is also compatible with latex condoms.
Personal Lubricant compatible with latex condoms, helps enhance intimacy.
K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
This K-Y® Brand Ultra Gel™ Personal Lubricant 510(k) summary does not contain the level of detail typically found in a clinical study report for a diagnostic device. It focuses on demonstrating substantial equivalence to a predicate device through pre-clinical and limited clinical testing, rather than establishing specific performance metrics against a defined acceptance criterion with a dedicated study.
However, based on the provided text, I can infer the "acceptance criteria" relate to performance as safe and effective, and "substantially equivalent" to the predicate device. The "study" refers to the body of testing conducted to support this claim.
Here's an attempt to structure the information based on your request, with significant caveats due to the nature of the provided document:
Acceptance Criteria and Device Performance for K-Y® Brand Ultra Gel™ Personal Lubricant
This submission focuses on demonstrating substantial equivalence of K-Y® Brand Ultra Gel™ Personal Lubricant to its predicate device, K-Y® Brand LIQUID Personal Lubricant. The acceptance criteria are implicitly met by demonstrating safety, non-irritation, and comparable performance to the predicate device, particularly in terms of lubricity and consumer satisfaction.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from submission) | Reported Device Performance |
|---|---|
| Safety: | |
| Non-irritating | Preclinical biocompatibility studies demonstrated the formulation was non-irritating. Human irritation studies under occluded and repetitive conditions showed the formulation was non-sensitizing and only mildly irritating. |
| Non-sensitizing | Human irritation studies demonstrated the formulation was non-sensitizing. |
| No significant pharmacotoxic effects | Preclinical biocompatibility studies demonstrated no significant pharmacotoxic effects. |
| Not associated with system toxicity | Preclinical biocompatibility studies demonstrated no system toxicity. |
| Compatibility: | |
| Compatible with latex condoms | Demonstrated compatibility with latex condoms according to ASTM D 3492 standards. |
| Performance (Compared to Predicate/Marketed Products): | |
| More lubricious than predicate (K-Y® Brand LIQUID Personal Lubricant) | Demonstrated to be more lubricious in laboratory coefficient of friction testing. |
| Preferred texture/consistency (compared to other commercially marketed vaginal moisturizer) | In consumer-use testing, the proposed formulation rated significantly higher for texture/consistency compared to another commercially marketed vaginal moisturizer. |
| Preferred moisturizing properties (compared to other commercially marketed vaginal moisturizer) | In consumer-use testing, the proposed formulation rated significantly higher for moisturizing properties compared to another commercially marketed vaginal moisturizer. |
| Substantial Equivalence: | |
| Same intended use as predicate | Confirmed: "Both devices have the same intended use." Both are personal lubricants to supplement natural lubrication, relieve friction, and enhance intimate sexual activity. |
| Similar formulations to predicate | Confirmed: "Both devices have... similar formulations." The new product consists mainly of water-soluble ingredients similar to other lubricants on the market. |
| Safe for intended use | Overall conclusion from laboratory, preclinical, and clinical testing is that the product is safe for its intended use. |
2. Sample Sizes Used for Test Set and Data Provenance
Due to the nature of this 510(k) summary, specific sample sizes for each test are not explicitly provided.
- Preclinical Biocompatibility Studies: Conducted by outside laboratories. Data provenance not specified (e.g., country of origin). These would typically be prospective animal or in vitro studies.
- Human Irritation Studies: Involved human subjects. Details on number of subjects, country of origin, or retrospective/prospective nature are not provided. These are typically prospective clinical trials.
- Consumer-Use Testing: Involved consumers. Specific sample size, country of origin, or retrospective/prospective nature are not provided. These are typically prospective user studies.
- Condom Compatibility Testing: Conducted according to ASTM D 3492 standards. This is lab-based testing; human subjects are not involved for this specific test.
3. Number of Experts and Qualifications for Ground Truth
Not applicable in the context of this 510(k) summary. "Ground truth" as understood in AI/imaging devices (e.g., expert consensus on medical images) is not relevant here. The "truth" is established by laboratory measurements, biological responses, and consumer feedback against defined criteria.
4. Adjudication Method for the Test Set
Not applicable. The tests described are laboratory analyses (e.g., coefficient of friction, biocompatibility, ASTM standards) and direct human or consumer responses (irritation, consumer preference). There is no "test set" requiring adjudication by multiple experts in the sense of a diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is relevant for diagnostic devices where human readers interpret medical images or data, and its goal is to assess the impact of AI assistance on human performance. K-Y® Brand Ultra Gel™ is a personal lubricant, not a diagnostic device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
No. This concept applies to AI algorithms. K-Y® Brand Ultra Gel™ is a physical product, not an algorithm. Its performance is evaluated through physical and biological interactions, as well as user experience.
7. Type of Ground Truth Used
The "ground truth" for the various tests can be categorized as follows:
- Preclinical Biocompatibility (Non-irritation, non-sensitizing, no toxicity): Laboratory measurements and biological assays (e.g., cytotoxicity tests, sensitization tests, systemic toxicity tests) following established GLP guidelines.
- Human Irritation Studies: Direct human response/observation by trained medical professionals (e.g., dermatologists or clinical researchers) assessing skin reactions.
- Condom Compatibility: Adherence to the specified ASTM D 3492 standard, which involves physical testing methods to evaluate material integrity and performance.
- Lubricity: Objective laboratory measurement of the coefficient of friction.
- Consumer-Use Testing (Texture/Consistency, Moisturizing Properties): Subjective consumer feedback and preference ratings, likely via questionnaires or surveys, quantified statistically.
8. Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. K-Y® Brand Ultra Gel™ is a chemical formulation, not an AI model.
9. How the Ground Truth for the Training Set was Established
Not applicable. 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.