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510(k) Data Aggregation

    K Number
    K183505
    Device Name
    KY Banksy Moisture
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2019-05-17

    (150 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K151884
    Why did this record match?
    Device Name :

    KY Banksy Moisture

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

    This product is intended for penile, vaginal and/or anal application 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 Banksy Moisture will be marketed as a non-sterile, non-prescription medical device for over-thecounter (OTC) use. This device is a water-based personal lubricant that contains: Water, Glycerin, Propanediol, Xanthan Gum, Benzoic Acid, Sodium Hyaluronate, Potassium Lactate and Lactic Acid. The tube material is composed of High-Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50-micron aluminum/inear low-density polyethylene seal and fitted with the Polypropylene (PP) cap. The tube will be packaged in an outer cardboard carton.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called "KY Banksy Moisture," a personal lubricant. It doesn't contain information about AI/ML models, human-in-the-loop performance, or a comparative effectiveness study. Therefore, I cannot provide details on those aspects.

    However, I can extract the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.

    Here's the information based on the provided text:

    1. Table of acceptance criteria and the reported device performance

    PropertyAcceptance Criteria (Specification)Reported Device Performance
    AppearanceClear colorless and homogeneous gel, free from extraneous matterClear colorless and homogeneous gel, free from extraneous matter
    OdorOdorlessOdorless
    ViscosityRelease: 3,000 – 6,500 cps; Stability: 3,000 - 8,000 cpsMaintained within specified ranges for release and stability.
    pH at 25°C3.5 – 4.5Maintained within the specified range.
    Benzoic AcidRelease: 0.207 – 0.253 %w/w; Stability: 0.150 - 0.253 %w/wMaintained within specified ranges for release and stability.
    Osmolality1050 to 1250 mOsm/kgMaintained within the specified range.
    Total Yeast and Mold Count (TYMC)≤10 cfu/g (per EP 8.0 Section: 2.6.12)
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