ATRIUM C-QUR OVT MESH

K100076 · Atrium Medical Corp. · FTL · Jan 26, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100076
• Device Name: ATRIUM C-QUR OVT MESH
• Applicant: Atrium Medical Corp.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 26, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atrium C-Qur™ OVT 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 non-absorbable supportive material.

Device Story

Atrium C-Qur OVT Mesh is a surgical mesh for fascial reinforcement. Device consists of two layers of mesh stitched together; second layer is cut into flaps to facilitate surgeon positioning and attachment at surgical site. Used in hernia repair, chest wall reconstruction, and wound management. Operates as a physical support material; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Surgical mesh; polymeric material; two-layer construction with flaps for positioning. Non-absorbable. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring fascial reinforcement during hernia repair, chest wall reconstruction, or treatment of traumatic/surgical wounds.

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.

Predicate Devices

• Atrium C-Qur Surgical Mesh (K050311)

Submission Summary (Full Text)

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K10076

JAN 2 6 2010

# K.

510K-Summary

For

Atrium C-Qur" Device Modification

### 1. SPONSOR

# Name and Address

ATRIUM MEDICAL CORP. 5 Wentworth Dr. Hudson, NH 03051, USA

# Establishment Registration Number

1219977

### DEVICE NAME 2.

Proprietary Name: Common/Usual Name: Classification Name:

Atrium C-Qur" OVT Mesh Surgical Mesh Mesh, surgical, polymeric

#### 3. DEVICE CLASS

Regulation Number: Regulation Name: Regulatory Class: Product Code

21 CFR 878.3300 Surgical mesh ll FTL

### PREDICATE DEVICES 4.

Concurrence Product Name Filing # Date 03/31/2006 Atrium C-Qur" Surgical Mesh K050311

### DEVICE DESCRIPTION 5.

The Atrium C-Qur" OVT Mesh is a surgical mesh used during surgical procedures. The mesh contains two layers of mesh stitched together. The second layer is cut into flaps. The intent of the addition of a second layer with flaps is to allow the surgeon to more easily position and attach the mesh to the surgical site.

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### INTENDED USE 6.

The Atrium C-Qur" OVT 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 non-absorbable supportive material.

## TECHNOLOGICAL CHARACTERISTICS 7.

C-Qur OVT Mesh's intended use and its material composition are identical to that of its predicate device and it is therefore substantially equivalent to its legally marketed predicate devices.

### PERFORMANCE DATA 8.

Results of verification testing indicate that the product meets the established performance requirements.

### CONCLUSION 9.

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act.

# Contact Person

Jacqueline E.M. Emery, BS Engineering

Sr. Regulatory Affairs Specialist Telephone: [phone] X5366

Email: [e-mail]

# Date

January 8, 2010

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 6 2010

Atrium Medical Corporation % Ms. Jacqueline E.M. Emery Senior Regulatory Affairs Specialist 5 Wentworth Drive Hudson, New Hampshire 03051

Re: K100076

Trade/Device Name: Atrium C-Qur™ OVT Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: January 08, 2010 Received: January 21, 2010

Dear Ms. Emery:

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

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# Page 2 - Ms. Jacqueline E.M. Emery

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH/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/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.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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I.

# Statement of Indications for Use

# Indications for Use Statement

| 510(k) Number (if known) | To be Assigned |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Atrium C-Qur ^TM OVT Mesh |
| Indications for Use | The Atrium C-Qur ^TM OVT Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other |

fascial surgical intervention procedures requiring reinforcement

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

with a non-absorbable supportive material

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 K100076