ADVANTA SST BIFURCATED GRAFT

K020767 · Atrium Medical Corp. · DSY · Apr 3, 2002 · Cardiovascular

Device Facts

• Record ID: K020767
• Device Name: ADVANTA SST BIFURCATED GRAFT
• Applicant: Atrium Medical Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atrium Advanta™ SST Bifurcated Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ SST Bifurcated Graft use in aortocoronary bypass applications or for use as a patch.

Device Story

Atrium Advanta™ SST Bifurcated Graft is a vascular prosthesis used for arterial reconstruction, segmental bypass, and arteriovenous access. Device is implanted by surgeons in clinical settings. It serves as a conduit for blood flow in the vascular system. It is not intended for aortocoronary bypass or patch use.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) premarket notification review.

Technological Characteristics

Vascular graft prosthesis; bifurcated design; indicated for arterial reconstruction and arteriovenous access. Classified under 21 CFR 870.3450, Product Code DSY.

Indications for Use

Indicated for patients requiring arterial vascular reconstruction, segmental bypass, or arteriovenous vascular access. Not indicated for aortocoronary bypass or patch applications.

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 circular seal for the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Hall RA/QA Manager Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051

APR 0 3 2002

Re: K020767

> Trade Name: Atrium Advanta™ SST Bifurcated Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis of less than 6 millimeters diameter. Regulatory Class: Class II (two) Product Code: DSY Dated: March 1, 2002 Received: March 8, 2002

Dear Ms. Hall:

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 - Ms. Karen Hall

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,

O.K. Till

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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known)

K020767

## Device Name

Atrium Advanta™ SST Bifurcated Graft

The Atrium Advanta™ SST Bifurcated Graft is intended for use in Indications for Use arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ SST Bifurcated Graft use in aortocoronary bypass applications or for use as a patch.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use_ OR

Atrium Medical Corporation

CONFIDENTIAL

B-1

Division of Cardiovascular & Respiratory Devices
510(k) Number K020767