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510(k) Data Aggregation

    K Number
    K073441
    Device Name
    ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2008-01-24

    (48 days)

    Product Code
    QEZ,DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K071342,K072269,K072769,K960970,K972610,K993564
    Predicate For
    K082382
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.

    Device Description

    Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.

    AI/ML Overview

    The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on functional and safety testing. However, it does not detail specific acceptance criteria or a dedicated study with performance metrics in the format requested.

    Therefore, I cannot provide the information in the requested table format regarding acceptance criteria and device performance based solely on the provided text. The document refers generally to "bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." This is a broad statement and does not specify the quantitative criteria or the results of such tests.

    Furthermore, the document does not contain information about:

    • Sample sizes used for test sets.
    • Data provenance (country of origin, retrospective/prospective).
    • Number and qualifications of experts for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • Sample size for the training set (as this is not an AI/ML device per the document).
    • How ground truth for the training set was established.

    This document is a regulatory submission for a medical device (thrombectomy set) based on substantial equivalence to predicate devices, not an AI/ML-based device requiring detailed performance metrics and ground truth establishment in the way the prompt implies.

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