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510(k) Data Aggregation

    K Number
    K170743
    Device Name
    AngioDynamics Total Abscession Biliary Drainage Catheter
    Manufacturer
    AngioDynamics, Inc.
    Date Cleared
    2017-03-30

    (20 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K060023
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.

    Device Description

    The Total Abscession Biliary Drainage Catheters includes a variety of related components including:

    • Total Abscession Biliary Drainage Catheter .
    • . Stiffening Cannula
    • Flexible Cannula .
    • Standard Injection Port ●
    • Needless Injection Port ●
      The Total Abscession Biliary Drainage Catheter family includes 8F, 10F, 12F, and 14F catheters in working lengths of 40cm. The Total Abscession Biliary Drainage Catheter are used to percutaneously drain fluids from the biliary tree.
    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device, specifically the AngioDynamics Total Abscession Biliary Drainage Catheter. It outlines the regulatory approval process and describes the device, its intended use, and comparative testing against a predicate device.

    However, the document does not contain any information about a study involving AI, image analysis, computer vision, or machine learning. It focuses on the physical properties and performance of a catheter, specifically material formulation changes and mechanical tests.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, as the input document does not describe such a device or study.

    To answer your request, I would need a document detailing an AI-powered medical device and its validation studies.

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