PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)

K110816 · Sofradim Production · FTL · Apr 19, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110816
• Device Name: PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PARIETEX™ Optimized 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 non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Device Story

Surgical mesh for tissue reinforcement during hernia repair and abdominal wall reconstruction; consists of 3D multifilament polyester knit for long-term reinforcement; one side covered with absorbable, hydrophilic porcine collagen and glycerol film to minimize visceral tissue attachment; film extends 5mm beyond mesh edge; includes attached 2D polyester textile flap; used by surgeons in clinical settings; provides mechanical support to abdominal wall; film barrier reduces post-operative adhesions.

Clinical Evidence

Bench testing and pre-clinical study conducted. Results demonstrated improved mechanical properties and equivalent in-vivo tissue attachment minimization compared to predicate devices.

Technological Characteristics

Materials: 3D multifilament polyester knit, porcine collagen, glycerol. Form factor: Rectangular or round mesh with 5mm film overhang. Principle: Non-absorbable polyester for structural reinforcement; absorbable collagen film for anti-adhesion barrier. No software or electronic components.

Indications for Use

Indicated for treatment of incisional hernias, abdominal wall repair, and parietal reinforcement of tissues in patients requiring soft tissue reinforcement.

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 Mesh (K002699)
• PARIETEX™ Composite Mesh (K040998)
• PARIETEX™ Composite Mesh (K050187)

Submission Summary (Full Text)

{0}------------------------------------------------

| 510(k) Summary of Safety and Effectiveness | | | | APR 19 2011 |
|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------|
| Submitter Information | | | | |
| Name: | Sofradim Production | | | |
| Address: | 116 avenue du Formans<br>01600 Trevoux<br>France | | | |
| Phone number: | [phone] | | | |
| Fax number: | [phone] | | | |
| Establishment Registration: | 9615742 | | | |
| Name of contact person: | James McMahon<br>Manager, Regulatory Affairs<br>Covidien<br>15 Crosby drive<br>Bedford, MA 01730 USA<br>Phone: [phone] | | | |
| Date prepared: | April 15, 2011 | | | |
| Name of device | | | | |
| Trade or proprietary name: | PARIETEX™ Optimized Composite Mesh | | | |
| Common or usual name: | Surgical Mesh | | | |
| Classification name: | Mesh, Surgical, Polymeric | | | |
| Classification panel: | General and Plastic Surgery (79) | | | |
| Regulation: | 21 CFR 878.3300 | | | |
| Product Code: | FTL | | | |
| Legally marketed devices to<br>which equivalence is claimed: PARIETEX™ Composite Mesh (K002699, K040998 and<br>K050187) | | | | |
| | Reason for 510(k) submission: The proposed PARIETEX™ Optimized Composite Mesh (PCO-<br>OSX references) has been modified compared to the predicate<br>devices as the knitting three dimensional textile has been<br>modified to obtain a higher mechanical resistance of the mesh<br>and the collagen film formulation has been changed to get a<br>film more resistant to handling. | | | |

··

{1}------------------------------------------------

· The PARIETEX™ Optimized Composite Mesh is available in Device description: rectangular and round shape. This device is made out of a three dimensional multifilament polyester knit for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol, and juts out 5 mm over the edge of the reinforcement. A bi-dimensional multifilament polyester textile flap is attached to the threedimensional reinforcement. The PARIETEX™ Optimized Composite Mesh is used for the Intended use of the device: reinforcement of tissues during surgical repair. Indications for use: lt is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable threedimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera. Summary companing the technological characteristics of the subject and predicate devices: The proposed PARIETEX™ Optimized Composite Mesh is equivalent to the predicate devices PARIETEX™ Composite Mesh (K002699, K040998 and K050187) in terms of its technological characteristics. No major technological changes are proposed to the predicate devices in this submission. Design modifications include a new collagen film formulation and changes to the knitting pattern. Performance testing was performed on both predicate and proposed mesh. The results of a pre-clinical study and bench testing, performed in accordance with FDA's Guidance for the Preparation of a Surgical Mesh, Notification Application Premarket for demonstrate improved mechanical properties, and equivalent in-vivo minimizing tissue attachment property. Performance data: Bench testing and pre-clinical testing has been conducted to evaluate the performance characteristics. Testing has shown that the PARIETEX™ Optimized Composite Mesh is equivalent in performance characteristics to the predicates PARIETEX™

Composite Mesh.

{2}------------------------------------------------

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 caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. The logo is simple and professional, reflecting the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 1 9 2011

Sofradim Production % Covidien Mr. James McMahon 15 Crosby Drive Bedford, Massachusetts 01730

Re: K110816

Trade/Device Name: PARIETEX™ Optimized Composite Mesh (PCO-OSX references Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 22, 2011 Received: March 25, 2011

Dear Mr. McMahon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{3}------------------------------------------------

Page 2 - Mr. James McMahon

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aty B. n h
for

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

Enclosure

{4}------------------------------------------------

Special 510(k) - PARIETEX™ Optimized Composite Mesh (PCO-OSX references)

## Indications For Use

510(k) Number (if known):

Device Name: PARIETEX™ Optimized Composite Mesh (PCO-OSX references)

## Indications For Use:

The PARIETEX™ Optimized 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 non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

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)
*David Keane for MKM*
(Division Sign-Off)

| Covidien Premarket Notification | Division of Surgical, Orthopedic, and Restorative Devices | Page 19 ^TM Trademark |
|---------------------------------|-----------------------------------------------------------|---------------------------------|
|---------------------------------|-----------------------------------------------------------|---------------------------------|

| 510(k) Number | K110816 |
|---------------|---------|
|---------------|---------|