MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH

K040998 · Sofradim Production · FTL · Apr 29, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040998
• Device Name: MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PARIETEX® COMPOSITE Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e., pertaining to the walls) reinforcement of tissues. The nonresorbable three-dimensional polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Device Story

Surgical mesh for open or laparoscopic tissue reinforcement; composed of polyethylene terephthalate (polyester) mesh with a resorbable hydrophilic collagen-based film. Polyester provides long-term soft tissue reinforcement; collagen film minimizes tissue attachment to viscera upon contact. Device is provided in various sizes/shapes. Used by surgeons in clinical settings. Modification from previous version involves changing collagen source from bovine to porcine dermis.

Clinical Evidence

Bench testing and animal study performed. Study compared porcine-derived collagen film to bovine-derived predicate. Results showed no statistically significant difference in tissue attachment or cellular inflammatory reaction between groups.

Technological Characteristics

Materials: Polyethylene terephthalate (polyester) mesh and resorbable hydrophilic collagen film (porcine dermis). Form factor: Three-dimensional mesh in various sizes/shapes. Principle: Mechanical reinforcement via polyester; anti-adhesion via resorbable film.

Indications for Use

Indicated for patients requiring surgical reinforcement of tissues, specifically for treatment of incisional hernias, abdominal wall repair, and parietal reinforcement. No specific age or gender restrictions noted.

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

• Sofradim PARIETEX®COMPOSITE Meshes (K002699)
• Sofradim UGYTEX® Mesh (K033376)

Submission Summary (Full Text)

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K040998

510(k) Summary for PARIETEX® COMPOSITE Mesh

#### 1. SPONSOR

APR 2 9 2004

Sofradim Production 116 Avenue du Formans 01600 Trevoux France

Christophe COSSON Contact: Telephone: [phone] Facsimile: 33 (0)4 74 08 90 02

#### 2. DEVICE NAME

PARIETEX® COMPOSITE Mesh Proprietary Name: Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh

### PREDICATE DEVICES 3.

Sofradim PARIETEX®COMPOSITE Meshes, K002699 Sofradim UGYTEX® Mesh, K033376

#### 4. DEVICE DESCRIPTION

The PARIETEX® COMPOSITE Mesh is a surgical mesh used during open (laparotomy) procedures or during laparoscopic procedures. The PARIETEX® COMPOSITE Mesh is made from polyethylenc terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance charactcristics of the mesh but serves to separate the coated side of the mesh from underlying tissues to minimize tissue attachment and ingrowth. The PARIETEX® COMPOSITE Mesh is offered in several sizes and shapes to accommodate the type and approach of the surgical procedure.

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## న. INTENDED USE

The PARIETEX® COMPOSITE Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hermas, abdominal wall repair, and parietal (i.e., pertaining to the walls) reinforcement of tissues. The nonresorbable three-dimensional polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Sofradim PARIETEX COMPOSITE (PCO) meshes are identical to the current PARIETEX® COMPOSITE (PCO) (K002699) meshes with the exception of a modification in the origin of the collagen of the hydrophilic film. In the current PCO meshes, the oxidized collagen is obtained from bovine dermis. In the proposed PCO meshes, the collagen is obtained from porcine dermis.

## 7. PERFORMANCE TESTING

The polyester mesh material used is not modified and remains the same as that described in the current PCO file (K002699). A study was conducted and demonstrated that there was no statistically significant difference between the test groups in tissue attachment. Both the porcine and bovine products were successful at minimizing tissue attachments. A histological analysis was also performed using randomly selected animals. Additionally, there was no difference in the cellular inflammatory reaction to the two products.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 9 2004

Sofradim Production c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K040998

Trade/Devicc Name: Sofradim PARIETEX® COMPOSITE (PCO) Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: April 16, 2004 Received: April 19, 2004

Dear Ms. McNamara-Cullinane:

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 interstatc 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 cither 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 madc 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 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.

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# Page 2 - Ms. Mary McNamara-Cullinane, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I market notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 it you desire 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO40998

# Indications for Use

510(k) Number (if known):

Device Name: Sofradim PARIETEX®COMPOSITE (PCO) Mesh

Indications for Use:

The PARIETEX® Composite Mesh is used for the reinforcement of tissues,during surgical The PARIETEX Composite Mesil is assurent of incisional hernias, abdominal wall repair, and parietal (i.c. pertaining to the walls) reinforcement of tissues. The non-resorbable threedimensional polyester mesh provides long-term reinforcement of soft tissues. On the dimensional polyester thesh provides form of the every attachment to the mesh in case of direct contact with the viscera.

Prescription Use X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-O Division of General, Restorative, and Neurological Devices

**510(k) Number** K640998