PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES

K072951 · Sofradim Production · OTP · Dec 19, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K072951
• Device Name: PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
• Applicant: Sofradim Production
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Indications for Use

Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Device Story

Parietene™ Duo and Parietene™ Quadra are monofilament polypropylene meshes for pelvic floor prolapse repair. Duo is pre-shaped for posterior repair; Quadra is pre-shaped for anterior repair. Both feature a dual-knit design: soft central section for compliant organ support; strong lateral sections for tension-free fixation. Used by surgeons in clinical settings for fascial defect repair. Provides long-term reinforcement and stabilization of pelvic floor structures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Monofilament polypropylene mesh; dual-knit construction (soft center, strong lateral sides); pre-shaped form factor. Biocompatibility evaluated per ISO 10993-1 and USP standards.

Indications for Use

Indicated for patients with vaginal wall prolapse requiring tissue reinforcement or stabilization of pelvic floor fascial structures via mechanical support or bridging material.

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

• UGYTEX™ Dual Knit Mesh (K051503)
• Parietene™ Polypropylene Mesh (K991400)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Sofradim Production<br>116, avenue du Formans<br>01600 Trevoux, France<br>Tel. No.: (33) 04 74 08 90 00 |
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DEC 1 9 2007

| CONTACT PERSON: | Sharon Alexander<br>Senior Associate, Regulatory Affairs<br>Covidien<br>150 Glover Avenue<br>Norwalk, CT 06856 USA<br>Tel. No.: [phone] |
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| DATE PREPARED: | October 17, 2007 |
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| TRADE/PROPRIETARY NAME: | Parietene™ Duo Polypropylene Mesh<br>Parietene™ Quadra Polypropylene Mesh |
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| COMMON/USUAL NAME: | Surgical Mesh |
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| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
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| PREDICATE DEVICE(S): | UGYTEXT™ Dual Knit Mesh (K051503)<br>Parietene™ Polypropylene Mesh (K991400) |
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| DEVICE DESCRIPTION: | Parietene™ Duo and Parietene™ Quadra are monofilament<br>polypropylene prolapse repair meshes. The nonabsorbable,<br>polypropylene mesh provides a long-term reinforcement for<br>support structures. Parietene™ Duo Polypropylene Mesh is a<br>pre-shaped mesh for posterior prolapse repair. Parietene™<br>Quadra Polypropylene Mesh is a pre-shaped mesh for anterior<br>prolapse repair. Parietene™ Duo and Parietene™ Quadra<br>meshes have a soft knit in the central section for compliant<br>organ support and a strong knit in the lateral sides to provide<br>strength for tension-free fixation of the mesh. |
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| INTENDED USE: | Parietene™ Duo and Parietene™ Quadra Polypropylene<br>Meshes are indicated for tissue reinforcement and long-lasting<br>stabilization of fascial structures of the pelvic floor in vaginal<br>wall prolapse where surgical treatment is intended either as<br>mechanical support or bridging material for the fascial defect. |
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| TECHNOLOGICAL<br>CHARACTERISTICS: | The technological characteristics, design and materials of the<br>meshes are substantially equivalent to the predicate<br>UGYTEX™ Dual Knit Mesh. |
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| MATERIALS: | Parietene™ Duo and Parietene™ Quadra Polypropylene<br>Meshes are comprised of materials that have been evaluated<br>for biocompatibility for their intended patient contact profile<br>according to ISO 10993-1 and/or USP standards. |
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1022951

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PERFORMANCE DATA: Testing was conducted to determine the performance characteristics of the subject meshes. The results demonstrate that the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are substantially equivalent to the predicate UGYTEX™ Dual Knit Mesh.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites.

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

Sofradim Production % Ms. Sharon Alexander Senior Associate, Regulatory Affairs Covidien 150 Glover Avenue NORWALK CT 06856

SEP 2 8 2012

Re: K072951

Trade/Device Name: Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: November 26, 2007 Received: November 27, 2007

Dear Ms. Alexander:

This letter corrects our substantially equivalent letter of December 19, 2007.

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 (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 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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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 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" (21 CFR 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 yours,

Sincerely yours,

Benjamin R. Fuchs

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K072951

## Indications For Use

510(k) Number (if known):

Device Name: Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes

Indications for Use:

Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(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 of General, Restorative, and Neurological Devices

| 510(k) Num | 16072957 |
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