ALBOGRAFT VASCULAR PROSTHESIS

K093231 · LeMaitre Vascular, Inc. · MAL · Jan 14, 2010 · Cardiovascular

Device Facts

• Record ID: K093231
• Device Name: ALBOGRAFT VASCULAR PROSTHESIS
• Applicant: LeMaitre Vascular, Inc.
• Product Code: MAL · Cardiovascular
• Decision Date: Jan 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AlboGraft Double Velour Knitted and Woven Grafts are indicated for use in the replacement or repair of Abdominal and Thoracic affected with aneurysmal or occlusive disease.

Device Story

AlboGraft Double Velour vascular prostheses are synthetic grafts used for replacement or repair of abdominal and thoracic vessels. Available in both knitted and woven configurations. Implanted by surgeons during vascular procedures to treat aneurysmal or occlusive disease. Device serves as a conduit to restore blood flow or replace diseased vessel segments.

Clinical Evidence

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

Technological Characteristics

Synthetic vascular graft; double velour construction; available in knitted and woven forms. Materials and design intended for replacement or repair of abdominal and thoracic vessels.

Indications for Use

Indicated for patients requiring replacement or repair of abdominal or thoracic vessels affected by 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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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

LeMaitre Vascular, Inc. c/o Ms. Erin Daly Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

JAN 1 4 2010

Re: K093231

Trade/Device Name: AlboGraft™ Double Velour Woven and Knitted Vascular Prostheses Regulation Number: 21 CFR 870.3450 Regulation Name: Synthetic/biologic composite vascular graft Regulatory Class: Class II Product code: MAL Dated: October 13, 2009 Received: October 14, 2009

Dear Ms. Daly:

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

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Page 2 - Ms. Erin Daly

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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

ura R. Vahner

B
D

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): K093231

Device Name:_Albograft Vascular Prosthesis

Indications For Use: The AlboGraft Double Velour Knitted and Woven Grafts are indicated for use in the replacement or repair of Abdominal and Thoracic affected with aneurysmal or occlusive disease.

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Munh R. hihus

n Sian-Of Invision of Cardiovascular Devices

510(k) Number k 093 23

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