LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980909
    Device Name
    VICHY SHOWER
    Manufacturer
    BOUVIER HYDRO, INC.
    Date Cleared
    1998-08-11

    (154 days)

    Product Code
    ILJ
    Regulation Number
    890.5100
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vichy Shower is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Vichy Shower." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed.

    However, the document does not contain the kind of information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/ML device evaluation. The Vichy Shower is a hydrotherapy device, not an AI/ML-driven diagnostic or treatment device, therefore, the requested information is not applicable to this submission.

    To clarify, the prompt asks for details typically found in submissions for AI/ML-enabled medical devices, which require extensive clinical validation studies to demonstrate safety and effectiveness. The Vichy Shower falls under a different regulatory pathway where substantial equivalence to existing devices is the primary criterion for market clearance, and typically does not involve the types of studies described in the prompt.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1