(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 : 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 |
§ 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.