ATRIUM MEDICAL CORPORATION C-QUR MESH

K050311 · Atrium Medical Corp. · FTL · Mar 31, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K050311
• Device Name: ATRIUM MEDICAL CORPORATION C-QUR MESH
• Applicant: Atrium Medical Corp.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Atrium C-QUR Mesh is a surgical mesh device used for soft tissue reinforcement. It is intended for use in procedures such as hernia repair, chest wall reconstruction, and management of traumatic or surgical wounds. The device provides a supportive material for fascial surgical interventions. It is used by surgeons in clinical or surgical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical mesh classified under 21 CFR 878.3300, Product Code FTL.

Indications for Use

Indicated for patients requiring soft tissue reinforcement, including hernia repair, chest wall reconstruction, and treatment of traumatic or surgical wounds or other fascial defects.

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 seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2006

Atrium Medical Corporation c/o Mr. Joseph P. DePaolo Vice President, Regulatory Affairs 5 Wentworth Drive Hudson, New Hampshire 03051

Re: K050311

Trade/Device Name: Atrium C-Qur'" Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 20, 2006 Received: March 22, 2006

Dear Mr. DePaolo:

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.

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

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## Page 2 - Mr. Joseph P. DePaolo

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product rainell 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 promated predicated on "ce 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Malkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K050311

Atrium C-QUR™ Mesh Device Name:

Indications For Use:

Atrium C-QUR™ Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative. and Neurological Devices

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KO 56311 510(k) Number_