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510(k) Data Aggregation

    K Number
    K081328
    Device Name
    PATHWAY PV ATHERECTOMY SYSTEM
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2008-07-17

    (66 days)

    Product Code
    MCW
    Regulation Number
    870.4875
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K024243,K043553,K053460,K061063,K061188,K901206,K954604,K970296,K993648,K890515,K922970
    Predicate For
    K082186,K082664,K083489,K091509,K092332,K093918,K100462,K101221,K101334,K110626,K111229,K120242,K130637,K132682
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

    Device Description

    The Pathway PV Atherectomy System consists of two primary components: {1} a PV Catheter and Control Pod and (2) a PV Console, which are packaged separately. Each of these system components is described generally as follows:

    • PV Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven PV Catheter and Control Pod. The PV Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls and LED indicators for device operational status. The unit, its electrical connectors, tubing. and aspirant collection bag are packaged in a double pouched tray.
    • Console: A reusable compact PV Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
      The Pathway PV Atherectomy System is compatible with 8F sheaths and exchange length (300cm or longer) 0.014" diameter guidewires.
    AI/ML Overview

    The provided text is a Fragmented 510(k) Summary. It includes general device information, predicate device comparison, and FDA's substantial equivalence letter for the Pathway PV™ Atherectomy System. However, it does not contain specific details about acceptance criteria or a study that proves the device meets such criteria.

    The document states that "Performance testing of the Pathway PV Atherectomy System included in vitro performance, biocompatibility, packaging, sterilization, electrical/EMC, animal, and clinical study." but does not provide results for these studies or define specific acceptance criteria.

    Therefore, I cannot fulfill the request to provide:

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