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510(k) Data Aggregation
(186 days)
Intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness.
The subject device will be packaged as follows:
- 12 mL Polyethylene terephthalate (PET) bottle
- Polypropylene (PP) pump
- Polypropylene (PP) snap-on cap
- Outer carton
The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.
The provided document describes the K-Y® Marilyn Pleasure Gel (K151884), a personal lubricant. It presents performance data to demonstrate its substantial equivalence to predicate devices, particularly concerning biocompatibility and condom compatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Standard | Reported Device Performance (K-Y® Marilyn Pleasure Gel) | Conclusion |
|---|---|---|
| Biocompatibility: | ||
| ISO 10993-10:2009 (Irritation) | Non-irritant to vaginal tissue of the rabbit. | Device shown to be non-irritating |
| ISO 10993-10:2009 (Sensitization) | No evidence of causing delayed dermal contact sensitization in the guinea pig. | Device shown to be non-sensitizing in guinea pig maximization study. |
| ISO 10993-11:2009 (Systemic Toxicity) | Not considered a sensitizer in the guinea pig maximization test (and by implication, no mortality or systemic toxicity). | Device did not cause any mortality or systemic toxicity |
| USP <87>: 2015 (Cytotoxicity) | Evidence of slight cytotoxicity to the cells exposed to the test item. | Device shown to be non-cytotoxic (Note: The reported performance states "slight cytotoxicity," but the conclusion states "non-cytotoxic." This discrepancy suggests a threshold where "slight" is deemed acceptable for "non-cytotoxic.") |
| Condom Compatibility: | ||
| ASTM D7661-10:2010 (Natural Rubber Latex & Polyisoprene Condoms) | Passed the condom compatibility test for 3NRL and PI condoms- with no tests having % difference values > 20% and the majority of results < 10%. | The Device is shown to be compatible with NRL and PI condoms. |
| Condom Compatibility: | ||
| ASTM D7661-10:2010 (Polyurethane Condoms) | Not compatible with polyurethane condoms. | The Device is shown to be not compatible with PU condoms. |
| Stability: | ||
| (Not explicitly a standard, but a criterion) | 9 month accelerated stability data provided for the formulation. The formulation has met the specification criteria at all temperature conditions. | 9 month shelf life demonstrated. |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the exact sample sizes (e.g., number of rabbits, guinea pigs, or specific condom batches) for each test. However, it indicates standard animal models were used:
- Biocompatibility (Irritation): Rabbit vaginal tissue.
- Biocompatibility (Sensitization/Systemic Toxicity): Guinea pig maximization test.
- Cytotoxicity: In vitro cell culture.
- Condom Compatibility: 3NRL (Natural Rubber Latex) and PI (Polyisoprene) condoms.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given it's a 510(k) submission, the studies would generally be conducted by the manufacturer or contracted labs under Good Laboratory Practice (GLP) standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the studies presented. These are performance tests against established scientific standards (ISO, USP, ASTM), not diagnostic accuracy studies requiring expert judgment for ground truth. The "ground truth" is defined by the technical criteria of the standards themselves (e.g., a certain percentage difference for condom compatibility, histological findings for irritation).
4. Adjudication method for the test set
Not applicable. The tests are objective measurements and interpretations against predefined criteria in the standards, not subjective assessments requiring adjudication.
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 a medical device (personal lubricant), not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the test results is based on:
- Standardized test methods and protocols: Defined by ISO, USP, and ASTM.
- Objective measurements: Such as percentage difference in condom properties (ASTM D7661-10).
- Biological observations: Such as absence/presence of irritation or sensitization in animal models, or cytotoxic effects in cell cultures.
- Analytical chemistry: For stability and compositional analysis.
8. The sample size for the training set
Not applicable. This document describes the testing of a physical product and its formulation, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no machine learning training set involved.
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