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510(k) Data Aggregation

    K Number
    K131778
    Device Name
    FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Date Cleared
    2013-11-14

    (150 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K962433,K052964,K113101
    Why did this record match?
    Device Name :

    FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.

    Device Description

    FUSION™ Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knitted polyester textile. These two layers are bonded together. The FUSION™ Bioline Vascular Grafts have a heparin/albumin coating on the interior surface of the graft.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the studies that support the FUSION™ and FUSION™ Bioline Vascular Grafts, based on the provided text:

    Device: FUSION™ and FUSION™ Bioline Vascular Grafts

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device (EXXCEL™ Soft ePTFE Vascular Grafts), with specific performance targets derived from clinical and bench testing.

    Acceptance Criteria (Implicit from Predicate Equivalence and Study Goals)Reported Device Performance (FUSION Bioline vs. EXXCEL / FUSION alone)
    Bench Testing: Conformance to performance specifications for various physical properties (e.g., tensile strength, kink diameter, burst strength, shear bond strength, etc.)Bench testing performed, and results suggest conformance to specifications. No new safety or performance issues raised.
    Biocompatibility: Demonstrated biocompatibility.Biocompatibility testing performed. No details on specific acceptance criteria or results are provided, but the submission implies satisfactory outcomes.
    Animal Studies: Acceptable vascular compatibility, patency, and tissue response.Canine Study (FUSION vs. EXXCEL): Patency was comparable. Healing process was comparable, with benign healing response and no safety concerns. Porcine Study (FUSION vs. FUSION Bioline; FUSION Bioline vs. GORE PROPATEN): Comparable surfaces between FUSION and FUSION Bioline, similar to EXXCEL. FUSION Bioline vs. GORE PROPATEN showed widely patent grafts and similar tissue response.
    Clinical Efficacy (Primary Patency at 6 months for FUSION Bioline): Non-inferiority to EXXCEL with a predefined margin.FUSION Bioline vs. EXXCEL (Randomized Multicenter Trial): Primary patency at 6 months for FUSION Bioline was 86.4% vs. 70.0% for EXXCEL. Difference was 16.4%, with a non-inferiority p-value of
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