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510(k) Data Aggregation

    K Number
    K072769

    Validate with FDA (Live)

    Device Name
    ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2007-11-14

    (47 days)

    Product Code
    QEZ,DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K071342,K072269,K960970,K972610,K042874
    Predicate For
    K113363
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
    The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3mm in diameter.
    The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2mm 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

    I am sorry, but the provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the AngioJet Ultra XMI, XVG, and Spiroflex Thrombectomy Sets, indicating they are substantially equivalent to previously cleared predicate devices.

    The "Functional and Safety Testing" section states that "Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." However, it does not provide details on:

    • Specific acceptance criteria (e.g., minimum thrombus removal efficacy, max embolization rate).
    • Quantitative results of these tests against acceptance criteria.
    • The sample size used for the test set.
    • Data provenance.
    • The number or qualifications of experts.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance studies.
    • Type of ground truth used.
    • Training set sample size or how ground truth for it was established.

    Without this information, I cannot complete the table or answer the specific questions about acceptance criteria and study details.

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