(150 days)
FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.
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.
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 |
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”