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510(k) Data Aggregation

    K Number
    K013289
    Device Name
    BIOTEQUE VAGINAL PESSARIES
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Date Cleared
    2001-12-27

    (86 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOTEQUE VAGINAL PESSARIES

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

    Bioteque's vaginal pessaries are indicated as removable devices placed in the vaginal cavity to provide a non-surgical alternative for the treatment of organ prolapse and to relieve the symptoms of pelvic relaxation with and without urinary incontinence.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The text is a 510(k) clearance letter from the FDA for a Bioteque Vaginal Pessary, indicating that the device is substantially equivalent to a legally marketed predicate device.

    The letter discusses regulatory aspects, such as compliance with the Federal Food, Drug, and Cosmetic Act, and general controls provisions. It also includes the specific indications for use of the Bioteque Vaginal Pessary. However, it does not detail any specific acceptance criteria for performance, nor does it describe a study that was conducted to demonstrate the device meets such criteria. Therefore, I cannot accurately fill in the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or types of ground truth.

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