PARIETEX COMPOSITE MONO PM MESH

K081126 · Sofradim Production · FTL · Aug 13, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081126
• Device Name: PARIETEX COMPOSITE MONO PM MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PARIETEX™ COMPOSITE Mono PM Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.

Device Story

PARIETEX™ COMPOSITE Mono PM Mesh is a surgical implant for soft tissue reinforcement; specifically parastomal hernia repair. Device consists of monofilament polyester fabric covered with an absorbable hydrophilic film (porcine collagen, polyethylene glycol, glycerol). Two designs available: both round; one features 3D polyester fabric with central opening; second features 3D polyester fabric with 2D central band. Film covers one side of mesh and extends 5mm over edges to minimize visceral tissue attachment. Non-absorbable polyester provides long-term reinforcement. Used by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Mechanical properties testing demonstrated performance characteristics similar to the predicate device. Biocompatibility evaluated in accordance with ISO 10993-1.

Technological Characteristics

Materials: Monofilament polyester fabric, absorbable hydrophilic film (porcine collagen, polyethylene glycol, glycerol). Biocompatibility: ISO 10993-1. Form factor: Round, two design variations (3D fabric with central opening or 3D fabric with 2D central band).

Indications for Use

Indicated for reinforcement of soft tissues during surgical repair, specifically for repair of parastomal hernias.

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

• PARIETEX™ COMPOSITE (PCO) Mesh (K040998)

Submission Summary (Full Text)

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K081126 pg102

## 510(k) Summary of Safety and Effectiveness

AUG 1 3 2008

| SUBMITTER: | Sofradim Production<br>116, avenue du formans<br>01600 Trevoux, France<br>Phone: [phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sharon Alexander<br>Senior Associate, Regulatory Affairs<br>Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473 USA<br>Phone: [phone] |
| DATE PREPARED: | July 17, 2008 |
| TRADE/PROPRIETARY NAME: | PARIETEX™ COMPOSITE Mono PM Mesh |
| COMMON/USUAL NAME: | Surgical Mesh |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
| PREDICATE DEVICE: | PARIETEX™ COMPOSITE (PCO) Mesh (K040998) |
| DEVICE DESCRIPTION: | PARIETEX™ COMPOSITE Mono PM Mesh is made from a<br>monofilament polyester fabric, covered with an absorbable<br>hydrophilic film. The meshes are available in two different<br>designs. Both are round in shape.<br>The first design is made from a three-dimensional<br>monofilament polyester fabric and has a circular opening in the<br>center. It is completely covered on one side with an<br>absorbable hydrophilic film made of collagen from porcine<br>origin, polyethylene glycol and glycerol.<br>The second design is made from a three dimensional<br>monofilament polyester fabric with a two-dimensional<br>monofilament polyester central band. One side of the second<br>design is completely covered with the hydrophilic film. On the<br>opposite side, only the two dimensional central band is coated<br>with the absorbable hydrophilic film.<br>On both designs the film extends 5 mm over the external edge<br>of the reinforcement, and also extends around the internal<br>edge of the circular opening if any. |
| INTENDED USE: | The PARIETEX™ COMPOSITE Mono PM Mesh is indicated<br>for the reinforcement of soft tissues during surgical repair, and<br>specifically for the repair of parastomal hernias. The non-<br>absorbable polyester mesh provides long term reinforcement<br>of soft tissues. The absorbable hydrophilic film minimizes<br>tissue attachment to the mesh when in direct contact with the<br>viscera. |

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TECHNOLOGICAL CHARACTERISTICS: The PARIETEX™ technological characteristics of COMPOSITE Mono PM Mesh are similar to those of the predicate device. Like the predicate, PARIETEX™ COMPOSITE Mono PM Mesh is manufactured from two components: polyester knitted mesh and a hydrophilic collagen film.

- MATERIALS: PARIETEX™ COMPOSITE Mono PM Mesh is comprised of materials that have been evaluated for biocompatibility in accordance with ISO 10993-1.
- PERFORMANCE DATA: Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ COMPOSITE Mono PM Mesh. Results of mechanical properties testing show that PARIETEX™ COMPOSITE Mono PM Mesh has similar performance characteristics to the predicate PARIETEX™ COMPOSITE Mesh.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The text is in all capital letters and is written in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 3 2008

Sofradim Production % Covidien Ms. Sharon Alexander Senior Regulatory Affairs Associate 60 Middletown Avenue North Haven, Connecticut 06473

Re: K081126

Trade/Device Name: PARIETEX™ COMPOSITE Mono PM Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regula.ory Class: II Product Code: FTL Dated: August 8, 2008 Received: August 11, 2008

Dear Ms. Alexander:

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 -- Ms. Sharon Alexander

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.

This letter will 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark M. Millman

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): ____________________________________________________________________________________________________________________________________________________

PARIETEX™ COMPOSITE Mono PM Mesh Device Name:

Indications For Use:

The PARIETEX™ COMPOSITE Mono PM Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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

| Covidien<br>Premarket 510(k) Number | K081116 | ^TM Trademark |
|-------------------------------------|---------|-------------------------|
|-------------------------------------|---------|-------------------------|