FUSION Vascular Graft

K153523 · Maquet Cardiovascular, LLC · DSY · Feb 16, 2016 · Cardiovascular

Device Facts

• Record ID: K153523
• Device Name: FUSION Vascular Graft
• Applicant: Maquet Cardiovascular, LLC
• Product Code: DSY · Cardiovascular
• Decision Date: Feb 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.

Device Story

FUSION Vascular Graft is a synthetic, two-layer vascular prosthesis; inner layer consists of extruded, expanded polytetrafluoroethylene (ePTFE); outer layer consists of knit polyester textile; layers are fused using a proprietary polycarbonate urethane adhesive. Device is used by surgeons to repair or replace peripheral arteries and to provide vascular access. Performance is validated through in-vitro testing, specifically burst testing after repeated puncture, to ensure functionality comparable to predicate devices.

Clinical Evidence

Bench testing only. In-vitro performance testing, specifically burst testing after repeated puncture, was conducted to demonstrate that the device's functionality and performance characteristics are comparable to the currently marketed FUSION Vascular Graft.

Technological Characteristics

Synthetic vascular graft; two-layer construction: inner layer extruded ePTFE, outer layer knit polyester textile; layers bonded with proprietary polycarbonate urethane adhesive. Class II device (21 CFR 870.3450).

Indications for Use

Indicated for patients requiring repair or replacement of peripheral arteries or vascular access.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• FUSION Vascular Grafts (K131778)
• EXXCEL ePTFE Vascular Graft (K962433)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The profiles are silhouetted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

## 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Maquet Getinge Group. The word "MAQUET" is in large, bold, blue letters. Below that, the words "GETINGE GROUP" are in smaller, gray letters. The logo is simple and modern.

## 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: [e-mail] Phone: [phone] Fax: [phone] 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.

{4}------------------------------------------------

| Technological<br>Characteristics | The Proposed FUSION and the predicate FUSION<br>device have the following similarities:<br>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 devices<br>have the following differences:<br>Vascular Access Indication for Use |
| | The Proposed FUSION Vascular Graft and the predicate<br>EXXCEL ePTFE Vascular Graft have the similar Vascular<br>Access Indication and share the same substrate. |
| | The difference is not considered a technological difference<br>and is substantially equivalent to the predicate devices. |
| Safety and<br>Performance: | MAQUET Cardiovascular's development process required<br>that the following activity be:<br>Performance testing - Burst After Repeated Puncture |
| | The results of the in-vitro tests conducted demonstrate that<br>the functionality and performance characteristics of the<br>device are comparable to the currently marketed FUSION<br>Vascular Graft. |
| Conclusion: | Based on the technological characteristics and performance<br>testing, the FUSION Vascular Grafts have been shown to<br>be substantially equivalent to the predicate device for the<br>intended use. |