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510(k) Data Aggregation

    K Number
    K230518
    Device Name
    HydraDose Vaginal Suppositories
    Manufacturer
    MD Labs LLC
    Date Cleared
    2023-06-23

    (116 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K213220
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HydraDose Vaginal Suppositories are a personal lubricant, for 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

    Device Description

    HydraDose Vaginal Suppositories is a glyceride-based personal lubricant for over-thecounter use. The subject device is a non-sterile solid preparation containing hyaluronic acid, cocoa butter, triglycerides, and cera alba. The subject device is packaged in sets of five a polyvinyl chloride (PVC)/polyethylene (PE) blister pack. The lubricant is not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets acceptance criteria in the context of an AI-powered medical device or diagnostic.

    The document is an FDA 510(k) premarket notification clearance letter for a medical device called "HydraDose Vaginal Suppositories," which is a personal lubricant. It discusses the substantial equivalence of this product to a predicate device based on its indications for use, technological characteristics, and non-clinical performance testing (biocompatibility, shelf life, condom compatibility).

    The request asks for details specific to the development and validation of an AI model, such as:

    • A table of acceptance criteria and reported device performance (for an AI-powered device)
    • Sample size and data provenance for a test set
    • Number and qualifications of experts for ground truth establishment
    • Adjudication method for test set ground truth
    • MRMC comparative effectiveness study details (human reader improvement with AI)
    • Standalone AI performance details
    • Type of ground truth used
    • Sample size for the training set
    • How training set ground truth was established

    None of these elements are present in the provided text as the device under review is a physical, chemical-based personal lubricant, not an AI or software-based medical device.

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