ATRIUM FLIXENE GRAFT

K060124 · Atrium Medical Corp. · DSY · Mar 30, 2006 · Cardiovascular

Device Facts

• Record ID: K060124
• Device Name: ATRIUM FLIXENE GRAFT
• Applicant: Atrium Medical Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: Mar 30, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atrium Flixene 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 Flixene Graft use in aortocoronary bypass applications or for use as a patch.

Device Story

Atrium Flixene Graft is a vascular prosthesis used for arterial reconstruction, segmental bypass, and arteriovenous access. Device serves as a conduit for blood flow in surgical procedures. Implanted by vascular surgeons in clinical/OR settings. Provides structural support for vessel repair or access creation. Benefits include restoration of vascular patency or establishment of reliable hemodialysis access.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and device characteristics.

Technological Characteristics

Vascular graft prosthesis; dimensions range from 3mm to 30mm. Class II device (21 CFR 870.3450).

Indications for Use

Indicated for patients requiring arterial vascular reconstruction, segmental bypass, or arteriovenous vascular access. Contraindicated for aortocoronary bypass applications and use as a patch.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2006

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

Re: K060124

Trade Name: Atrium Flixene Graft ( 3mm to 30mm ) Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: February 27, 2006 Received: February 28, 2006

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 r lease be actived and thermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I vith 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 premaince nevice 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,

Bhimmon 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): K060124

Device Name:

Indications For Use:

The Atrium Flixene 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 Flixene Graft use in aortocoronary bypass applications or for use as a patch.

Prescription Use __X_

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)

Bhemnuna

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K060124

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Atrium Medical Corporation

CONFIDENTIAL