SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS

K051312 · Veryan Medical Limited · DSY · Nov 4, 2005 · Cardiovascular

Device Facts

• Record ID: K051312
• Device Name: SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
• Applicant: Veryan Medical Limited
• Product Code: DSY · Cardiovascular
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SwirlGraft™ Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels. The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arterio-venous conduit for vascular access.

Device Story

SwirlGraft™ Bypass and Vascular Access Grafts are 6 mm diameter expanded polytetrafluoroethylene (ePTFE) vascular grafts; feature small amplitude helical geometry along length. Bypass Graft version utilizes thin-wall ePTFE with full external support; Vascular Access Graft version utilizes standard-wall ePTFE without external support. Devices implanted surgically by physicians to restore blood flow in peripheral arteries or provide vascular access for hemodialysis. Helical geometry intended to influence flow dynamics. Safety and effectiveness established via bench and animal testing.

Clinical Evidence

Bench testing and animal data provided. No human clinical trial data included. Testing demonstrated safety and effectiveness equivalent to the predicate device.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Geometry: 6 mm diameter with small amplitude helical configuration. Bypass version: thin-wall with external support. Vascular Access version: standard-wall without external support. Sterilization: not specified.

Indications for Use

Indicated for patients requiring bypass or reconstruction of occluded/diseased peripheral arterial blood vessels or subcutaneous arteriovenous conduits for 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

• Sulzer Vascutek ePTFE Vascular Prosthesis (K992832)

Submission Summary (Full Text)

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Kos 1312

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## 510(k) SUMMARY

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

| Submitter's Name: | Veryan Medical Limited |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | Sir Leon Bagrit Centre<br>Mechanical Engineering Building<br>Imperial College<br>Exhibition Road<br>London, SW7 2AZ |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Gill Cash |
| Date Prepared: | May 18, 2005 |
| Device Trade Name: | SwirlGraft™ Bypass Graft<br>SwirlGraft™ Vascular Access Graft |
| Device Common Name: | Vascular Graft |
| Device Classification Name: | Vascular Graft Prosthesis of 6mm and Greater<br>Diameter |
| Device Classification: | Class II |

Intended Use:

The SwirlGraft™ Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels.

The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arterio-venous conduit for vascular access.

Summary of Substantial Equivalence:

The SwirlGraft™ Bypass and Vascular Access Grafts are substantially equivalent to Sulzer Medica's Sulzer Vascutek ePTFE Vascular Prosthesis (K992832).

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KOS1312 p. 20f2

Device Description:

The SwirlGraft™ Bypass and Vascular Access Grafts are 6 mm diameter expanded polytetraflouro-ethylene (ePTFE) vascular grafts that are manufactured with a small amplitude helical geometry along their length. The SwirlGraft™ Bypass Graft has a thin wall ePTFE construction and a full ePTFE external support. The SwirlGraft™ Vascular Access Graft is a standard wall ePTFE construction with no external support.

Technological Characteristics:

Comparative testing of the SwirlGraft™ Bypass and Vascular Access Grafts with the predicate device found that the technological characteristics, performance and principle of operation were substantially equivalent.

Performance Data:

Bench testing and animal data demonstrated that the safety and effectiveness of the SwirlGraft™ Bypass and Vascular Access Grafts is equivalent to the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.

NOV - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Veryan Medical, Ltd. c/o Ms. Judith Danielson Senior Regulatory consultant CardioMed Device Consultants, LLC 1327 Bluegrass Way Gambrills, MD 21054

Re: K051312

Trade Name: Vascular Solutions SwirlGraft™ Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Regulatory Class: II (two) Product Code: DSY Dated: October 04, 2005 Received: October 05, 2005

Dear Ms. Danielson;

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Judith Danielson

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dima R. Vichner

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): K051312

SwirlGraft™ Bypass Graft Device Name: SwirlGraft™ Vascular Access Graft

Indications For Use:

The SwirlGraft™ Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels.

The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arteriovenous conduit for vascular access.

Prescription Use × (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)

Duna R. V. hines

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510(k) Number_Korl 312