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510(k) Data Aggregation

    K Number
    K970196
    Device Name
    T-WALL UNCUFFED TRACHEAL TUBE
    Manufacturer
    VITAL SIGNS, INC.
    Date Cleared
    1997-08-21

    (212 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The T-Wall™ Uncuffed Tracheal Tube is indicated for tracheal intubation and airway management.

    Device Description

    T-Wall™ Uncuffed Tracheal Tube

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (T-Wall™ Uncuffed Tracheal Tube). This type of document primarily confirms that a device has been found substantially equivalent to a predicate device and allows it to be marketed.

    It does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, expert qualifications, or AI-related metrics. The letter focuses on regulatory approval rather than a scientific study report.

    Therefore, I cannot provide the requested table and information based solely on the text you provided.

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