(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 <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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| 510(k) Number: | K131778 |
|---|---|
| Date Prepared: | September 12, 2013 |
| Device Owner: | MAQUET Cardiovascular LLC45 Barbour Pond DriveWayne, New Jersey 07470 |
| Contact Personnel:Title:Email:Phone: | Marylou InsingaRegulatory Affairs Specialist IImarylou.insinga@maquet.com973-709-7442Fax: 973-807-1658 |
| Trade Name: | FUSION™ and FUSION™ Bioline Vascular Grafts |
| Common Name: | Vascular Graft |
| Classification Name: | Vascular Graft Prosthesis |
| Predicate Device: | EXXCEL™ Soft ePTFE Vascular Grafts (K962433, K052964 andK113101) |
| Device Description: | FUSION™ Vascular Grafts are synthetic vascular graftsconstructed of two layers. The inner layer is comprised ofexpanded polytetrafluoroethylene (ePTFE). The outer layer iscomprised of knitted polyester textile. These two layers arebonded together. The FUSION™ Bioline Vascular Grafts have aheparin/albumin coating on the interior surface of the graft. |
| Indications for Use: | FUSION™ and FUSION™ Bioline Vascular Grafts are designed torepair or replace peripheral arteries. |
| TechnologicalCharacteristicsSafety and Performance: | Bench testing, biocompatibility, animal and clinical testing wereperformed to support a determination of substantialequivalence.Bench testing performed:Longitudinal Tensile StrengthWall ThicknessOblique Suture Retention StrengthLongitudinal Suture Retention StrengthKink DiameterRelaxed Internal DiameterLongitudinal Axial StretchWater Entry Pressure (WEP)Radial Burst Strength (Burst Pressure)Usable LengthShear Bond Strength |
NOV 1 4 2013
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Also for products with external support (supported):
- o Bead Peel Strength
- o Bead Wrap Density
- Crush Resistance o
For FUSION Bioline, grafts were additionally tested for: Heparin concentration.
Animal studies:
The FUSION/FUSION Bioline Vascular Grafts were tested in two animal models.
In vivo canine and porcine implant studies were performed to assess device safety by evaluating vascular compatibility. The canine study was designed to address tissue response and patency. The model used for the canine study was a femoral arteriovenous shunt; the study compared the FUSION Vascular Graft with Exxcel Soft Vascular Graft.
- · Patency was comparable for the FUSION Vascular Graft and Exxcel Soft Grafts.
- · The healing process of the FUSION Vascular Graft was comparable with the Exxcel Soft Graft. Both Grafts demonstrated a benign healing response with no evidence of safety concerns.
The porcine study compared FUSION to FUSION Bioline and FUSION Bioline to GORE PROPATEN in a porcine carotid model. FUSION to FUSION Bioline were compared for comparable surfaces and expected clinical hemocompatibility. The surfaces were found to be comparable as well as comparable to Exxcel. FUSION Bioline was compared to GORE PROPATEN for patency and tissue response. The grafts remained widely patent in both groups and tissue response was similar.
Clinical Studies:
Randomized Multicenter Trial of FUSION Bioline Graft for Femoropopliteal Bypass
Methods: Prospective, randomized, multicenter trial performed to evaluate the safety and efficacy of FUSION Bioline Vascular Graft to demonstrate substantial equivalence with EXXCEL Soft ePTFE. Eighteen US and 7 European centers enrolled 207 subjects with Rutherford 1-5 chronic limb ischemia and planned prosthetic femoropopliteal (above- and below-knee) bypass. Subjects were randomized 1:1 to either FUSION-Bioline or EXXCEL Soft ePTFE. Patency was assessed by vascular imaging and ABI. Early (6 month) results were analyzed for primary graft patency and major adverse limb events (MALE).
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Efficacy Endpoints: Primary efficacy endpoint was primary patency of the graft at 6 months. Secondary endpoints were primary assisted patency, secondary patency, and time to hemostasis of suture hole bleeding.
Safety Endpoints: Composite MALE (major reintervention rates, major amputation rates) and periprocedural deaths at 6 months.
Results: Primary patency at 6 months was 86.4% for FUSION Bioline compared to 70.0% for the EXXCEL group. The difference was 16.4% with a non-inferiority p-value of <0.0001. Primaryassisted patency rate for FUSION Bioline was 86.4% vs. 73.0% for EXXCEL (p=0.0174). Secondary patency rates at 6 months did not reach significance with 88.3% for FUSION Bioline vs. 80.8% for EXXCEL (p=0.1371). MALE occurred in 14.3% (15/105) for FUSION Bioline and 29.7% (30/101) for EXXCEL at 6 Months (P=0.0109). No perioperative deaths occurred in either group. Suture-hole bleeding times were significantly shorter with FUSION Bioline (p<0.0001); observed mean times to hemostasis were 3.5 ±4.7 minutes for FUSION Bioline vs. 11.0 ±10.6 minutes for the EXXCEL group.
European Postmarketing Trial of FUSION Graft for Femoropopliteal Bypass
Methods: Prospective, single-arm multicenter, trial performed to evaluate the safety and efficacy of FUSION vascular graft. Ten European study centers enrolled 117 subjects with peripheral artery disease scheduled for above-knee bypass. Eligible subjects received the FUSION graft. Patency was assessed by vascular imaging and ABI. Twelve-month results were analyzed for primary graft patency and major adverse limb events (MALE): major reintervention rates, maior amputation rates, and perioperative deaths.
Endpoints: Primary efficacy endpoint was primary patency of the FUSION graft at 12 months. Primary safety endpoint was the assessment of composite major adverse limb events (MALE) and periprocedural deaths.
Results: Preliminary 12-month results submitted for the 510(k) provided endpoint results in 92 subjects. Primary patency rate at 12 months was 84.8% (78/92) and the observed secondary patency was 95.4% (83/87). Thirteen (11.2%) subjects had major adverse limb events. No periprocedural deaths.
The results of these tests provide reasonable assurance that the device(s) have been designed and tested to assure conformance to the performance specifications, perform as intended and are safe and effective. The test data provided in the submission supplies evidence that the device(s) are substantially equivalent to
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the predicate device. No new safety or performance issues were raised during the testing regimen.
Conclusion:
Based on the Indications for Use, technological characteristics, safety and performance testing, the FUSION™ and FUSION™ Bioline Vascular Grafts have been shown to be safe and effective for their intended use and substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2013
MAQUET Cardiovascular LLC C/O Marylou Insinga Regulatory Affairs Specialist II 45 Barbour Pond Drive Wayne, NJ 07470
Re: K131778 Trade/Device Name: FUSION™ and FUSION™ Bioline Vascular Grafts Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: November 1, 2013 Received: November 4, 2013
Dear Ms. Insinga:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Marylou Insinga
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): 〈〈〈〈〈〈〈アプタ
Device Name: FUSION™ and FUSION™ Bioline Vascular Grafts
Indications For Use:
FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.
Prescription Use __ x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.”