PARIETEX PROGRIP MESH

K081050 · Sofradim Production · FTL · May 28, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081050
• Device Name: PARIETEX PROGRIP MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.

Device Story

PARIETEX™ PROGRIP™ Mesh is a surgical mesh for hernia repair; available in pre-cut elliptic slit form with self-gripping flap or rectangular form. Constructed from knitted monofilament polyester with integrated monofilament polylactic acid (PLA) resorbable pins on one side. Pins facilitate placement, positioning, and fixation to surrounding tissue; colored yarn marker assists orientation. Used by surgeons in clinical settings for hernia repair. Device provides mechanical support to tissue; resorbable pins eliminate need for additional fixation methods during initial placement. Benefits include simplified mesh positioning and fixation.

Clinical Evidence

Bench and animal testing conducted. Mechanical property testing demonstrated performance characteristics similar to the predicate PARIETEX™ Mesh.

Technological Characteristics

Knitted monofilament polyester mesh with monofilament polylactic acid (PLA) resorbable fixation pins. Materials evaluated per ISO 10993-1 and USP standards. Form factors include pre-cut elliptic slit with flap or rectangular. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring inguinal or incisional hernia repair.

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™ Mesh (K982532)
• PARIETEX™ Mesh TET1208D and TET1409D (K003990)
• PREVADH™ Mesh (K073287)
• TICRON™ Suture (K930591)

Submission Summary (Full Text)

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

## 510(k) Summary of Safety and Effectiveness

MAY 2 8 2008

Aug

981050

| 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: | April 10, 2008 |
| COMMON/USUAL NAME: | Surgical Mesh |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
| PREDICATE DEVICE(S): | PARIETEX™ Mesh (K982532)<br>PARIETEX™ Mesh TET1208D and TET1409D (K003990)<br>PREVADH™ Mesh (K073287)<br>TICRON™ Suture (K930591) |
| DEVICE DESCRIPTION: | PARIETEX™ PROGRIP™ Mesh will be available in 2 shapes:<br><ul><li>Pre-cut, elliptic slit mesh with a self-gripping overlapping flap. Right or left side.</li><li>Rectangular simple mesh.</li></ul> These meshes and the overlapping flaps of the pre-cut versions are made from knitted monofilament polyester with monofilament polylactic acid (PLA) resorbable pins on one side. The PLA pins facilitate placing, positioning and fixation of the overlapping flap and the meshes to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps in orientation. |
| INTENDED USE: | PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair. |
| TECHNOLOGICAL CHARACTERISTICS: | The technological characteristics of PARIETEX™ PROGRIP™ Mesh are similar to those of the predicate devices. PARIETEX™ PROGRIP™ meshes are manufactured with knitted monofilament polyester and monofilament polylactic acid resorbable pins. |
| MATERIALS: | PARIETEX™ PROGRIP™ Mesh is comprised of materials that have been evaluated in accordance with ISO 10993-1 and/or USP standards. |

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

## PERFORMANCE DATA:

Bench and animal testing has been conducted to evaluate the performance characteristics of PARIETEX™ PROGRIP™ Mesh. Results of mechanical property testing show that PARIETEX™ PROGRIP™ has similar performance characteristics to the predicate PARIETEX™ Mesh.

Kogjo

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

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 eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 8 2008

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

Re: K081050

Trade/Device Name: PARIETEX™ PROGRIP™ Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 10, 2008 Received: April 14, 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

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

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 Postmarlet 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

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

## Indications For Use

510(k) Number (if known):

Device Name: PARIETEX™ PROGRIP™ Mesh

Indications for Use:

PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.

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)

Neil R.P. Ogden for RKM

(Divisio Division of General, Restorative. and Neurological Devices

510(k) Number_KO81050