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    K Number
    K151884
    Device Name
    K-Y Marilyn Pleasure Gel
    Manufacturer
    Reckitt Benckiser LLC
    Date Cleared
    2016-01-11

    (186 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K955648,K140193
    Why did this record match?
    Device Name :

    K-Y Marilyn Pleasure Gel

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 / StandardReported 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
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