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510(k) Data Aggregation

    K Number
    K974300
    Device Name
    TELEMED SYSTEMS RETRIEVAL BASKET
    Manufacturer
    TELEMED SYSTEMS, INC.
    Date Cleared
    1997-12-19

    (32 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TELEMED SYSTEMS RETRIEVAL BASKET

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

    The Tele Med Systems, INC. Retrieval Basket is for use with The Endoscopic Gate I track.

    Device Description

    Retrieval Basket

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the "TeleMed System Retrieval Basket" from 1997. This type of document, especially from this era, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a novel AI/ML device.

    Therefore, the information required to populate the fields regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and sample sizes for training and testing is not available in the provided text.

    The clearance letter confirms that the device is substantially equivalent to legally marketed devices based on its indications for use, and it mentions compliance with Current Good Manufacturing Practice (GMP) requirements. However, it does not describe specific performance metrics or the studies used to validate them in the way a modern AI/ML device submission would.

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