VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES

K043552 · Vascutek, Ltd. · DSY · Jan 5, 2005 · Cardiovascular

Device Facts

• Record ID: K043552
• Device Name: VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
• Applicant: Vascutek, Ltd.
• Product Code: DSY · Cardiovascular
• Decision Date: Jan 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CREATION OF SUBCUTANEOUS ARTERIOVENOUS CONDUITS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

Device Story

VASCUTEK PTFE Supported ePTFE Vascular Prosthesis; synthetic graft used for vascular access or arterial bypass/reconstruction. Implanted surgically by vascular surgeons in clinical settings. Provides conduit for blood flow in patients with occlusive or diseased vessels. Device functions as a mechanical replacement or bypass for native vasculature.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Expanded polytetrafluoroethylene (ePTFE) vascular prosthesis with support structure. Classified under 21 CFR 870.3450 as a vascular graft prosthesis (Product Code: DSY).

Indications for Use

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

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.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 2005

Vascutek Ltd. c/o Dr. Karen Kelso Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland

Re: K043552

PTFE Supported Vascular Prosthesis Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: December 20, 2004 Received: December 27, 2004

Dear Ms. Kelso:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 9 ro(t) premaine is substantially equivalent (for the indications for use stated in the enclosure) the arress of essess of esses of the success on interstate for use stated in the encrosure) to regary manced people Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1976, the enaculture with the provisions of the Federal Food, Drug, devices that have been recadsined in accession will af a premarket approval application (PMA).) and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the device, beljeveres to the connual registration, listing of
general controls provisions of the Act include requirements for annual registration general controls provisions of the Fields requirements of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entralians, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peacharing.
publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Karen Kelso

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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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/dsma/dsmamain.html

Sincerely yours.

Bhimimar 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): | K043552 |
|---------------------------|------------------------------------------------------|
| Device Name: | VASCUTEK PTFE SUPPORTED ePTFE VASCULAR<br>PROSTHESES |
| Indications For Use: | CREATION OF SUBCUTANEOUS |

BCUTANEOUS Indications For Use: CREATION CONDUITS ARTERIOVENOUS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Abimimano

(Division Sign-Off) Division of Cardlovascular Devices 510(K) Number_Ko43552

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