ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT

K102596 · Atrium Medical Corp. · DSY · Oct 5, 2010 · Cardiovascular

Device Facts

• Record ID: K102596
• Device Name: ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
• Applicant: Atrium Medical Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: Oct 5, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atrium Graduated Wall Flixene Ax-Bifem Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Device Story

Atrium Graduated Wall Flixene Ax-Bifem Graft is a vascular graft prosthesis used for arterial reconstruction, bypass, and arteriovenous access. Device implanted by surgeons in clinical settings to restore or provide vascular access. Functions as a conduit for blood flow. Benefits include facilitating necessary vascular repairs or access in patients requiring surgical intervention.

Clinical Evidence

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

Technological Characteristics

Vascular graft prosthesis; Class II; Product Code DSY; 21 CFR 870.3450.

Indications for Use

Indicated for patients requiring arterial vascular reconstruction, segmental bypass, or arteriovenous vascular access.

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/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Atrium Medical Corporation c/o Mr. Raymond J. Kelly IV 5 Wentworth Dr. Hudson, NH 03051

ОСТ 5 2010

Re: K102596

Trade/Device Name: Atrium Graduated Wall Flixene Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: August 29, 2010 Received: September 9, 2010

Dear Mr. Kelly:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

smer R. V. Viner

E
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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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## INDICATIONS FOR USE

510(k) Number (if known): K1022596

Device Name:

Atrium Graduated Wall Flixene Ax-Bifem Graft

Indications for Use:

The Atrium Graduated Wall Flixene Ax-Bifem Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Prescription Use __ V (Part 21 CFR 801 Subpart D AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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