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    K Number
    K140506
    Device Name
    JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
    Manufacturer
    TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
    Date Cleared
    2015-04-17

    (414 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K080978
    Why did this record match?
    Device Name :

    JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL

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

    JoyDrops® Natural Personal Lubricant Gel is a personal lubricant, 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, polyisoprene, and polyurethane condoms.

    Device Description

    JoyDrops® Natural Personal Lubricant Gel is a water-based personal lubricant gel that is contained in a 3.38 fluid ounces (100 mL) polymer container with a pump dispenser.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device: Joy Drops™ Natural Personal Lubricant Gel. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets acceptance criteria through clinical studies involving human readers or AI.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic device utilizing AI is not applicable to this document.

    The document primarily focuses on:

    • Biocompatibility testing: To ensure the product is safe for contact with human tissue.
    • Condom compatibility testing: To ensure it doesn't degrade various types of condoms.
    • Comparison to a predicate device: To demonstrate substantial equivalence based on intended use, technological characteristics, and safety/performance data.

    Here's an attempt to answer the questions based only on the information available for this specific product, acknowledging that many questions are not directly relevant to a lubricant's 510(k) submission:

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria (from text)Reported Device Performance (from text)
    Condom Compatibility:
    Compatible with latex condoms (per ASTM D7 6661-10 and ARDL method)Found to be compatible with latex condoms.
    Compatible with polyisoprene condoms (per ASTM D7 6661-10 and ARDL method)Found to be compatible with polyisoprene condoms.
    Compatible with polyurethane condoms (per ASTM D7 6661-10 and ARDL method)Found to be compatible with polyurethane condoms.
    Biocompatibility (Safety):
    No cellular toxicity (per ISO 10993 methodology)No cellular toxicity was found.
    No systemic toxicity (per NAMSA protocol, FDA approved)No systemic toxicity was found. (Table: No Mortality or Evidence of Systemic Toxicity)
    Non-irritant to vaginal tissue (per ISO 10993-10)The test article was considered a non-irritant to vaginal tissue. (Table: No Irritation Observed)
    No skin sensitization (per ISO 10993-10/AI standard practices)No skin sensitization was reported. (Table: No Skin Sensitization was Observed for both animal and human patch tests)
    No skin irritation (Human Patch Test, 30 min and 24 hours)No Skin Irritation was Observed (for both 30 minutes and 24 hours).
    Stability:
    Shelf-life of three yearsA shelf-life of three years was established based on data from temperature control cabinets (22°C and 60°C).
    Microbiological specifications
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