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510(k) Data Aggregation

    K Number
    K993951
    Device Name
    SPOT ENDOSCOPIC MARKER
    Manufacturer
    CHEK-MED SYSTEMS
    Date Cleared
    2000-02-18

    (88 days)

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

    SPOT ENDOSCOPIC MARKER

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

    IS INDICATED FOR ENDOSCOPICALLY MARKING LESIONS IN THE GE TRACT MARKING LESTONS IN CONSTITUTIONATES WHEN THE REQUIRE SURGICAL REMOVAL WITHIN (30) THEFTY DAYS .

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a device meets such criteria.

    The document is a letter from the FDA to "Chek-Med Systems, Inc." regarding their "Spot Endoscopic Marker" device. It is a 510(k) premarket notification letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

    The text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Information about sample sizes, data provenance, or the number/qualifications of experts.
    3. Adjudication methods.
    4. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    5. A standalone performance study.
    6. The type of ground truth used.
    7. Information about training set size or how its ground truth was established.

    The letter primarily concerns the regulatory approval status of the device based on substantial equivalence and general controls provisions of the Act.

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