(69 days)
FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.
FUSION Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of extruded, expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate urethane adhesive.
This document is a 510(k) premarket notification for the FUSION Vascular Graft, specifically for an AV Access Indication. The acceptance criteria and study described pertain to the performance of this vascular graft.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with specific numerical thresholds for "Burst After Repeated Puncture." However, it implies that the device's performance must be "comparable" to the currently marketed FUSION Vascular Graft.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality comparable to currently marketed FUSION Vascular Graft | "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed FUSION Vascular Graft." |
| Performance characteristics comparable to currently marketed FUSION Vascular Graft | "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed FUSION Vascular Graft." |
| "Burst After Repeated Puncture" performance satisfactory | Performance testing was conducted for "Burst After Repeated Puncture" and found to be comparable to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "in-vitro tests" but does not specify the number of grafts or test articles used.
- Data Provenance: The study was "in-vitro testing" conducted as part of Maquet Cardiovascular's development process. The country of origin is not specified, but the applicant (Maquet Cardiovascular, LLC) is based in Wayne, NJ, USA. The study is prospective in the sense that it's conducted to support a new indication for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (in-vitro performance testing of a physical device) does not typically involve human experts establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is based on established engineering principles and measurement techniques for material and device performance. Therefore, this information is not applicable to this submission.
4. Adjudication Method for the Test Set
Not applicable for this type of in-vitro performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a 510(k) submission for a physical vascular graft, not an AI diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
For this in-vitro performance testing, the "ground truth" is based on the objective measurements obtained from standardized material and device performance tests, such as "Burst After Repeated Puncture." The performance is then compared against established performance of a predicate device (FUSION Vascular Graft) or internal benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2016
Maquet Cardiovascular, LLC Mark Dinger Sr. Regulatory Affairs Specialist 45 Barbour Pond Drive Wayne, NJ 07470
Re: K153523
Trade/Device Name: FUSION Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: December 1, 2015 Received: December 9, 2015
Dear Mark Dinger:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153523
Device Name FUSION Vascular Grafts
Indications for Use (Describe)
FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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FUSION Vascular Graft AV Access Indication 510(k) Summary Prepared in accordance with 21 CFR Part 807.92
510(k) Number: K153523 Date Prepared: 1 December 2015 Device Owner: MAQUET Cardiovascular LLC 45 Barbour Pond Drive Wayne, New Jersey 07470 Contact Personnel: Mark Dinger Sr. Regulatory Affairs Specialist Title: Email: mark.dinger@maquet.com Phone: 973-709-7691 Fax: 973-909-9954 Trade Name: FUSION Vascular Grafts Device Generic Name: Vascular Graft According to 21 CFR 870.3450 of the Federal Food, Drug Classification: and Cosmetic Act, the device classification is Class II, Product code DSY. K131778 FUSION Vascular Grafts Predicate Devices: (SE: 14 November 2013) K962433 EXXCEL ePTFE Vascular Graft (SE: 1 April 1997) FUSION Vascular Grafts are synthetic vascular grafts Device Description: constructed of two layers. The inner layer is comprised of extruded, expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate urethane adhesive. FUSION Vascular Grafts are designed to repair or replace Indications for Use: peripheral arteries and to provide vascular access.
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| TechnologicalCharacteristics | The Proposed FUSION and the predicate FUSIONdevice have the following similarities:the same operating principles, incorporate the same basic design, sterilized using the same materials and processes, has same packaging, the same biocompatibility. |
|---|---|
| The Proposed FUSION and the predicate FUSION deviceshave the following differences:Vascular Access Indication for Use | |
| The Proposed FUSION Vascular Graft and the predicateEXXCEL ePTFE Vascular Graft have the similar VascularAccess Indication and share the same substrate. | |
| The difference is not considered a technological differenceand is substantially equivalent to the predicate devices. | |
| Safety andPerformance: | MAQUET Cardiovascular's development process requiredthat the following activity be:Performance testing - Burst After Repeated Puncture |
| The results of the in-vitro tests conducted demonstrate thatthe functionality and performance characteristics of thedevice are comparable to the currently marketed FUSIONVascular Graft. | |
| Conclusion: | Based on the technological characteristics and performancetesting, the FUSION Vascular Grafts have been shown tobe substantially equivalent to the predicate device for theintended use. |
§ 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.”