ADVANTA T-GRAFT

K051332 · Atrium Medical Corp. · DSY · Sep 29, 2005 · Cardiovascular

Device Facts

• Record ID: K051332
• Device Name: ADVANTA T-GRAFT
• Applicant: Atrium Medical Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atrium Advanta™ T-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™ T-Graft use in aortocoronary bypass applications or for use as a patch.

Device Story

Atrium Advanta™ T-Graft is a vascular graft prosthesis used for arterial reconstruction, segmental bypass, and arteriovenous access. Device functions as a conduit for blood flow in vascular surgery. Used by vascular surgeons in clinical/OR settings. Provides structural support for bypass or access procedures; facilitates blood flow restoration or hemodialysis access. Does not support aortocoronary bypass or patch use.

Clinical Evidence

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

Technological Characteristics

Vascular graft prosthesis; 6mm and greater diameter; Class II; Product Code DSY. Meets requirements for vascular graft materials under 21 CFR 870.3450.

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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SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051332

Atrium Advanta™ T-Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis 6mm and greater diameter Regulatory Class: Class II (two) Product Code: DSY Dated: July 21, 2005 Received: July 25, 2005

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.

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Page 2 - Ms. Karen Hall

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/industry/support/index.html.

Sincerely yours.

Duna R. Vachner

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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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KOS1332 p. Loft

## Indications for Use

510(k) Number (if known):

Device Name: Atrium Advanta™ T-Graft

Indications For Use:

The Atrium Advanta™ T-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™ T-Graft use in aortocoronary bypass applications or for use as a patch.

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)

R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K 0 5 / 33 2

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