PARIE TENE PROGRIP MESH

K101197 · Sofradim Production · FTL · May 5, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101197
• Device Name: PARIE TENE PROGRIP MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 5, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Surgical mesh for inguinal and incisional hernia repair; available as pre-cut elliptic slit mesh with self-gripping flap or rectangular simple mesh. Constructed from knitted monofilament polypropylene with resorbable polylactic acid (PLA) pins on one side. Pins facilitate placement, positioning, and fixation to surrounding tissue; colored yarn marker aids orientation. Used by surgeons in clinical settings to reinforce tissue during hernia repair. Device provides mechanical support to the abdominal wall; resorbable pins reduce need for additional fixation methods.

Clinical Evidence

Bench testing only. Performance characteristics evaluated and compared to predicate PARIETEX PROGRIP™; results confirm equivalence.

Technological Characteristics

Knitted monofilament polypropylene mesh with resorbable polylactic acid (PLA) pins. Biocompatible materials compliant with ISO 10993-1 and USP standards. Form factors include pre-cut elliptic slit mesh with self-gripping flap or rectangular simple mesh. Mechanical fixation via resorbable pins.

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 Progrip™ Mesh (K081050)
• PARIETENE™ Mesh (K991400)
• PARIETEX™ TET Mesh (K003990)

Submission Summary (Full Text)

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Special 510(k) - PARIETENE PROGRIP™ MESH

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## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Sofradim Production<br>116, avenue du formans<br>01600 Trevoux, France<br>Phone: [phone] | K101197 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Sharon Alexander<br>Associate Manager, Regulatory Affairs<br>Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473 USA<br>Phone: [phone] | MAY - 5 2010 |
| DATE PREPARED: | April 26, 2010 | |
| TRADE/PROPRIETARY NAME: | PARIETENE PROGRIP™ Mesh | |
| COMMON/USUAL NAME: | Surgical Mesh | |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | |
| PREDICATE DEVICE(S): | PARIETEX Progrip™ Mesh (K081050)<br>PARIETENE™ Mesh (K991400)<br>PARIETEX™ TET Mesh (K003990) | |
| DEVICE DESCRIPTION: | PARIETENE PROGRIP™ Mesh is available in 2 forms:<br>• Pre-cut, elliptic slit mesh with self-gripping overlapping flap<br>(right or left side)<br>• Rectangular simple mesh<br>These meshes and the overlapping flaps of the pre-cut versions<br>are made of knitted monofilament polypropylene with polylactic<br>acid (PLA) resorbable pins on one of the sides. The PLA pins<br>facilitate placement, positioning and fixation of the overlapping<br>flap and the mesh to the surrounding tissue. A colored yarn<br>marker on the medial edge of the pre-cut mesh helps orientation. | |
| INDICATION: | PARIETENE PROGRIP™ Mesh is indicated for inguinal and<br>incisional hernia repair. | |
| TECHNOLOGICAL<br>CHARACTERISTICS: | PARIETENE PROGRIP™ meshes are made with knitted<br>monofilament polypropylene and monofilament polylactic acid<br>resorbable pins. The intended use and fundamental technology of<br>PARIETENE PROGRIP™ Mesh are equivalent to that of the<br>predicate PARIETEX PROGRIP™. | |
| MATERIALS: | PARIETENE PROGRIP™ Mesh is comprised of biocompatible<br>materials that are in compliance with ISO 10993-1 and/or USP<br>standards. | |
| PERFORMANCE DATA: | Bench testing has been conducted to evaluate the performance<br>characteristics of PARIETENE PROGRIP™. Testing has shown<br>that the PARIETENE PROGRIP™ is equivalent in performance<br>characteristics to the predicate PARIETEX PROGRIP™. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Sofradim Production % Covidien - Div. of Tyco Healthcare Group LP Ms. Sharon Alexander Associate Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

MAY - 5 2010

Re: K101197

Trade/Device Name: Parietene Progrip Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: April 28, 2010 Received: April 28, 2010

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. 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

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Page 2 - Ms. Sharon Alexander

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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## Indications for Use

KIQULS 510(k) Number (if known):

Device Name:

PARIETENE 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 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause for MXM

(Divisi Division of Surgical, Orthope and Restorative Device

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510(k) Number K101147