PARIETEX POLYESTER MESH WITH INTRODUCER

K071629 · Sofradim Production · FTL · Jul 10, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071629
• Device Name: PARIETEX POLYESTER MESH WITH INTRODUCER
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Parietex® Polyester Mesh with Introducer is indicated for use in the reinforcement of tissue during surgical repair of inguinal hernias through laparoscopic approach.

Device Story

Parietex® Polyester Mesh is a surgical mesh designed for tissue reinforcement during laparoscopic inguinal hernia repair. The device includes an introducer and attached suture loops to facilitate insertion and removal of the mesh during the surgical procedure. It is intended for use by surgeons in a clinical/OR setting. The device functions as a mechanical support for tissue repair. The addition of the introducer system is the primary modification to the predicate device.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Surgical mesh with introducer and suture loops. Materials meet ISO 10993-1 and USP biocompatibility standards. Identical design and materials to predicate device.

Indications for Use

Indicated for reinforcement of tissue during laparoscopic inguinal 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® Polyester Mesh (K982532)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

JUL 1 0 2007

| SUBMITTER: | Sofradim Production<br>116, avenue du Formans<br>01600 Trevoux- France<br>Tel. No .: (33) 04 74 08 90 00 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Renee Borgesano<br>Manager, Regulatory Affairs<br>[phone] |
| DATE PREPARED: | June 13, 2007 |
| TRADE/PROPRIETARY NAME: | Parietex® Polyester Mesh |
| COMMON/USUAL NAME: | Surgical Mesh |
| CLASSIFICATION NAME: | Surgical Mesh |
| PREDDICATE DEVICE(S): | Parietex® Polyester Mesh (K982532) |
| DEVICE DESCRIPTION: | The Parietex® Polyester Mesh will be packaged with an<br>Introducer. Suture loops are attached to the meshes and aide<br>in inserting and removing the mesh from the Introducer. |
| INTENDED USE: | The Parietex® Polyester Mesh with Introducer is indicated for<br>use in the reinforcement of tissue during surgical repair of<br>inguinal hernias through laparoscopic approach. |
| TECHNOLOGICAL CHARACTERISTICS: | The technological characteristics, design and materials of the<br>meshes are identical to the predicate device. |
| MATERIALS: | All components of the Parietex® Polyester Mesh with Introducer<br>are comprised of materials that have passed biocompatibility<br>testing for their intended patient contact profile according to ISO<br>10993-1 and/or USP standards. |
| PERFORMANCE DATA: | Bench tests were conducted to demonstrate that the<br>modification to the device did not change the performance when<br>compared to the predicate device. |

United States Surgical Premarket Notification Page 22
™Tradem rk

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus-like design, with three lines representing the branches of government and three wavy lines below, possibly representing the people served by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sofradim Production % United States Surgical Ms. Renee Borgesano Manager, Regulatory Affairs 150 Glover Avenue Norwalk, Connecticut 06856

## JUL 10 2007

Re: K071629

Trade/Device Name: Parietex® Polyester Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 13, 2007 Received: June 14, 2007

Dear Ms. Borgesano:

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. Renee Borgesano

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Por

ark N. Melkerson
rector

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):

Ko.71629

Device Name: Parietex® Polyester Mesh

Indications for Use:

The Parietex® Polyester Mesh is indicated for use in the reinforcement of tissue during surgical repair of inguinal hernias through laparoscopic approach.

Prescription Use X (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)

(Division Sign-Off) (Division Sign of General, Restorative, and Neurological Devices

**510(k) Number** k071625

United States Surgical Premarket Notification

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