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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
    Predicate For
    K153523
    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 <0.0001. This demonstrates superiority, satisfying a non-inferiority criterion.
    Clinical Efficacy (Shorter Suture-Hole Bleeding Times for FUSION Bioline): Significantly shorter than EXXCEL.FUSION Bioline vs. EXXCEL (Randomized Multicenter Trial): Suture-hole bleeding times were significantly shorter (p<0.0001) for FUSION Bioline (3.5 ±4.7 minutes) compared to EXXCEL (11.0 ±10.6 minutes).
    Clinical Safety (MALE at 6 months for FUSION Bioline): Acceptable rates of Major Adverse Limb Events (MALE) compared to EXXCEL.FUSION Bioline vs. EXXCEL (Randomized Multicenter Trial): MALE occurred in 14.3% (15/105) for FUSION Bioline and 29.7% (30/101) for EXXCEL at 6 months (P=0.0109), showing a lower rate for FUSION Bioline.
    Clinical Safety (Perioperative Deaths at 6 months for FUSION Bioline): No perioperative deaths.FUSION Bioline vs. EXXCEL (Randomized Multicenter Trial): No perioperative deaths occurred in either group.
    Clinical Efficacy (Primary Patency at 12 months for FUSION Graft - European Trial): Acceptable patency rate (e.g., similar to historical data or predicate performance).FUSION Graft (European Postmarketing Trial): Preliminary 12-month primary patency rate was 84.8% (78/92).
    Clinical Safety (MALE for FUSION Graft - European Trial): Acceptable rates of MALE and no periprocedural deaths.FUSION Graft (European Postmarketing Trial): 13 (11.2%) subjects had major adverse limb events. No periprocedural deaths.

    2. Sample Size Used for the Test Set and the Data Provenance

    • Randomized Multicenter Trial (FUSION Bioline vs. EXXCEL):
      • Sample Size: 207 subjects randomized 1:1 (105 FUSION Bioline, 101 EXXCEL).
      • Data Provenance: Retrospective analysis of prospective data. Country of origin: 18 US centers and 7 European centers.
    • European Postmarketing Trial (FUSION Graft):
      • Sample Size: 117 subjects enrolled. Preliminary 12-month results reported for 92 subjects.
      • Data Provenance: Retrospective analysis of prospective data. Country of origin: 10 European study centers.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    This information is not provided in the document. The studies are clinical trials, and ground truth (e.g., patency, MALE) would typically be established by the treating physicians and clinical investigators overseeing the subjects. The document does not specify the number or qualifications of these individuals beyond them being involved in the respective trial centers.

    4. Adjudication Method for the Test Set

    This information is not explicitly provided in the document. For clinical endpoints like patency and MALE, adjudication often involves an independent clinical events committee (CEC), but the document does not detail if or how such adjudication was performed. The p-values suggest statistical analysis of collected data.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. The studies described are clinical trials comparing the device to a predicate (or historical data for the FUSION-alone trial) in human subjects, not a study assessing human reader performance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    This question is not applicable as the device is a physical vascular graft, not an algorithm or AI system.

    7. The Type of Ground Truth Used

    • Clinical Trials (both FUSION Bioline vs. EXXCEL and FUSION Graft European Trial):
      • Patency: Assessed by vascular imaging and ABI (Ankle-Brachial Index). This represents clinical outcome data determined through objective measurements and clinical judgment.
      • Major Adverse Limb Events (MALE): Composite endpoint including major reintervention rates, major amputation rates, and periprocedural deaths. This is based on clinical outcome data/patient outcomes.
      • Suture-hole bleeding times: Measured clinically. This is clinical outcome data.
    • Animal Studies:
      • Vascular compatibility, tissue response, patency: Assessed through in vivo observation, potentially histology, and imaging. This represents animal model outcomes/pathology.
    • Bench Testing:
      • Physical properties: Measured against defined engineering specifications. This is based on laboratory testing results.

    8. The Sample Size for the Training Set

    This question is not applicable as the device is a physical vascular graft and does not involve AI or machine learning models that require a training set.

    9. How the Ground Truth for the Training Set Was Established

    This question is not applicable for the same reason as above.

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