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510(k) Data Aggregation

    K Number
    K062609
    Device Name
    MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    2006-10-06

    (31 days)

    Product Code
    DQY,LIT
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANGIODYNAMICS Profiler® PTA Balloon Catheter is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.

    Device Description

    AngioDynamics Profiler® PTA Balloon Catheter

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the AngioDynamics Profiler® PTA Balloon Catheter. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or methodology of such studies.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and the reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method for the test set.
    5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    6. Whether a standalone performance study was done.
    7. The type of ground truth used.
    8. The sample size for the training set.
    9. How the ground truth for the training set was established.
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