ULTRAMAX WOVEN VELOUR VASCULAR GRAFT

K013577 · Atrium Medical Corp. · DSY · Jan 25, 2002 · Cardiovascular

Device Facts

• Record ID: K013577
• Device Name: ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
• Applicant: Atrium Medical Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultramax™ Woven Velour Vascular Graft is indicated for surgical repair, bypass or replacement of damaged vessels of the abdomen in cases of aneurysmal or occlusive disease.

Device Story

Ultramax™ Woven Velour Vascular Graft is a prosthetic device used for surgical repair, bypass, or replacement of damaged abdominal vessels. It is intended for use in patients with aneurysmal or occlusive disease. The device is implanted by a surgeon in an operating room setting. It functions as a mechanical conduit to restore blood flow in the abdominal vasculature.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics.

Technological Characteristics

Woven velour vascular graft; indicated for abdominal vascular repair. Class II device (21 CFR 870.3460).

Indications for Use

Indicated for patients requiring surgical repair, bypass, or replacement of damaged abdominal vessels due to aneurysmal or occlusive disease.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Mr. Joseph P. DePaolo Sponsor for B. Braun Surgical GmbH Director of Regulatory Affairs Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051

Re: K013577

> Trade/Device Name: Ultramax™ Woven Velour Vascular Graft (abdominal location) Regulation Number: 21 CFR 870.3460 Regulation Name: Prosthesis, Vascular Graft Regulatory Class: II (two) Product Code: DSY Dated: October 24, 2001 Received: October 29, 2001

Dear Mr. De Paolo:

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.

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

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Page 2 - Mr. Joseph P. DePaolo

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Deata Willn

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ 1_of_1__

510(k) Number (if known):__K013577

Device Name: Ultramax™ Woven Velour Vascular Graft

Indications For Use: The Ultramax™ Woven Velour Vascular Graft is indicated for surgical repair, bypass or replacement of damaged vessels of the abdomen in cases of aneurysmal or occlusive disease.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danke Tilh

Division of Cardiovascular & Respiratory Devices
510(k) Number K013577

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)