C-QUR V -PATCH MESH

K090909 · Atrium Medical Corp. · FTL · Jun 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090909
• Device Name: C-QUR V -PATCH MESH
• Applicant: Atrium Medical Corp.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Atrium C-QUR V-Patch™ Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

Device Story

Atrium C-QUR V-Patch™ Mesh is a surgical implant used for reinforcement of soft tissue defects. It consists of a nonabsorbable mesh material designed to provide structural support in hernia repair, chest wall reconstruction, and management of traumatic or surgical wounds. The device is intended for use by surgeons in clinical or operating room settings. It functions as a permanent scaffold to facilitate tissue ingrowth and fascial reinforcement. The device is provided sterile for surgical implantation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nonabsorbable surgical mesh; intended for fascial reinforcement. Class II device (21 CFR 878.3300).

Indications for Use

Indicated for patients requiring hernia repair, chest wall reconstruction, or reinforcement of traumatic/surgical wounds and fascial defects using nonabsorbable supportive material.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and head facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atrium Medical Corporation % Mr. Joseph P. De Paolo VP Regulatory and Clinical Affairs 5 Wentworth Drive Hudson, New Hampshire 03051

JUN - 4 2009

Re: K090909

Trade/Device Name: Atrium C-QUR V-Patch™ Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: March 27, 2009 Received: April 10, 2009

Dear Mr. De Paolo:

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 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

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Page 2-Mr. Joseph P. De Paolo

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/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

index.html.

Sincerely yours,

Mark N. Melkerson
Division of Surgical, Orthopedic

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 169090909 510(k) Number (if known): Atrium C-QUR V-Patch™ Mesh Device Name: Indications for Use:

> Atrium C-QUR V-Patch™ Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Keene for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090909

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Atrium Medical Corporation

CONFIDENTIAL