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510(k) Data Aggregation

    K Number
    K051059
    Device Name
    AMSURE 100% SILICONE FOLEY CATHETER
    Manufacturer
    AMSINO INTERNATIONAL, INC.
    Date Cleared
    2005-06-28

    (63 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K062240
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AMSure 100% Silicone Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract

    Device Description

    AMSure 100% Silicone Foley Catheter

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AmSure 100% Silicone Foley Catheter. This document is a regulatory approval letter and an "Indications for Use Statement". It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used for test set or data provenance.
    3. Number of experts or their qualifications for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance study details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document confirms the device's substantial equivalence to legally marketed predicate devices and is a regulatory clearance, not a technical report detailing the device's validation study.

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