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510(k) Data Aggregation

    K Number
    K993103
    Device Name
    ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    1999-12-10

    (85 days)

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

    ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER,

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

    The endoscopes serve to visualize the inside of the patient via natural or surgically generated access. For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as surgery, urology, gynecology, and ENT.

    Device Description

    Rigid Endoscopes, 10mm diameter, Models 8934.431, 0°, 8934.432, 30°, and 8934.433, 50°

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding Rigid Endoscopes. It confirms the substantial equivalence of the device to legally marketed predicate devices.

    However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. The letter is an administrative document confirming regulatory clearance, not a summary of a performance study.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details from the provided text.

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