PARIETEX MONOFILAMENT POLYESTER MESH

K090858 · Sofradim Production · FTL · May 6, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090858
• Device Name: PARIETEX MONOFILAMENT POLYESTER MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PARIETEX™ - Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.

Device Story

PARIETEX™ Monofilament Polyester Mesh is a non-absorbable, bi-dimensional, knitted polyester surgical mesh. It is used by surgeons in clinical settings for the repair of inguinal and ventral hernias. The device provides structural reinforcement to the abdominal wall during hernia repair procedures. It is supplied in a rectangular shape.

Clinical Evidence

Bench testing only. Performance characteristics were evaluated and compared to the predicate MERSILENE™ mesh, demonstrating similarity.

Technological Characteristics

Non-absorbable, bi-dimensional, knitted monofilament polyester mesh. Materials are biocompatible and compliant with ISO 10993-1 and/or USP standards. Rectangular form factor.

Indications for Use

Indicated for inguinal and ventral hernia repair in patients requiring surgical mesh.

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

• MERSILENE™ (Ethicon)
• PARIETEX™ COMPOSITE Mono PM Mesh (K081126)

Submission Summary (Full Text)

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| K090858 | 510(k) Summary of Safety and Effectiveness | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| SUBMITTER: | Sofradim Production<br>116, avenue du formans<br>01600 Trevoux, France<br>Phone: [phone] | | |
| CONTACT PERSON: | | Angela L. Bunn, RAC<br>Associate Manager, Regulatory Affairs<br>Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473 USA<br>Phone: [phone] | MAY - 6 2009 |
| DATE PREPARED: | March 27, 2009 | | |
| TRADE/PROPRIETARY NAME: | PARIETEX™ - Monofilament Polyester Mesh | | |
| COMMON/USUAL NAME: | Surgical Mesh | | |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | | |
| PREDICATE DEVICE(S): | MERSILENE™ (Ethicon) (Preamendment device, marketed<br>prior to May 28, 1976) | | |
| | PARIETEX™ COMPOSITE Mono PM Mesh (K081126) | | |
| DEVICE DESCRIPTION: | | PARIETEX™ - Monofilament Polyester Mesh is made out of a<br>non-absorbable bi-dimensional monofilament polyester knitting<br>and is available in rectangular shape. | |
| INTENDED USE: | PARIETEX™ - Monofilament Polyester Mesh is indicated for<br>inguinal and ventral hernia repair. | | |
| TECHNOLOGICAL<br>CHARACTERISTICS: | | The technological characteristics of PARIETEX™ -<br>Monofilament Polyester Meshes are similar to those of the<br>predicate devices. The proposed device is similar to the<br>predicate device (PARIETEX™ Composite Mono PM Mesh) in<br>that the base materials of polyester are the same. In regards<br>to other technological aspects the predicate device<br>(MERSILENE™) are similar in form and function. | |
| MATERIALS: | PARIETEX™ - Monofilament Polyester Mesh is comprised of<br>biocompatible materials that are in compliance with ISO<br>10993-1 and/or USP standards. | | |
| PERFORMANCE DATA: | Bench testing has been conducted to evaluate the<br>performance characteristics of PARIETEX™ - Monofilament<br>Polyester Mesh. Testing has shown that the PARIETEX™ -<br>Monofilament Polyester Mesh is similar in performance<br>characteristics to the predicate MERSILENE™. | | |

PARIETEX™ - Monofilament Polyester Mesh

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sofradim Production % Covidien Ms. Angela L. Bunn, RAC 60 Middletown Avenue North Haven, Connecticut 06473

Re: K090858

Trade/Device Name: ParietexTM Monofilament Polyester Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 27, 2009 Received: March 30, 2009

Dear Ms. Bunn:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at

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Page 2 - Ms. Angela L. Bunn, RAC

[phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours,

Mil. B.P. Ogle

Mark N. Melkerson 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

510(k) Number (if known):

Device Name: Parietex™ Monofilament Polyester Mesh

Indications For Use:

The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.

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)

Daniel Krane

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number KD90858