UGYTEX SUAL KNIT MESH

K051503 · Sofradim Production · OTP · Aug 5, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051503
• Device Name: UGYTEX SUAL KNIT MESH
• Applicant: Sofradim Production
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The UGYTEX® Dual Knit Mesh is 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

UGYTEX® Dual Knit Mesh is a surgical implant consisting of a monofilament polypropylene mesh partially coated with an absorbable hydrophilic porcine collagen film. The polypropylene component provides long-term structural reinforcement, while the collagen film minimizes visceral attachment during the healing process. The device is provided in various configurations, including rectangular sheets and anterior/posterior repair systems. It is intended for use by surgeons in clinical settings to treat pelvic floor fascial defects. By providing mechanical support or bridging for damaged tissue, the mesh facilitates stabilization of the pelvic floor, potentially improving patient outcomes in vaginal wall prolapse repair.

Clinical Evidence

Bench testing only.

Technological Characteristics

Monofilament polypropylene mesh; central portion coated with absorbable hydrophilic porcine collagen film. Available in rectangular sheets, anterior, and posterior repair system configurations. Non-active, implantable device.

Indications for Use

Indicated for patients with vaginal wall prolapse requiring tissue reinforcement and stabilization of pelvic floor fascial structures, serving as mechanical support or bridging material for fascial defects.

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

• Sofradim UGYTEX® Mesh (K033376)

Submission Summary (Full Text)

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K051503

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AUG 5 - 2005 510(k) Summary for UGYTEX® Dual Knit Mesh

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#### I. SPONSOR

Sofradim Production 116 Avenue du formans 01600 Trevoux France

Contact: Christophe Cosson Telephone: [phone] Facsimile: 33 (0)4 74 08 90 02

#### 2. DEVICE NAME

UGYTEX® Dual Knit Mesh Proprietary Name: Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh

### 3. PREDICATE DEVICES

Sofradim UGYTEX® Mesh K033376

### 4. DEVICE DESCRIPTION

The Sofradim UGYTEX® Dual Knit Mesh is a monofilament, polypropylene mesh coated in the central portion with an absorbable hydrophilic film of porcine collagen. The nonabsorbable, polypropylene mesh provides a long-term reinforcement for support structures. The hydrophilic film minimizes visceral attachment to the mesh which may occur during the healing process.

The UGYTEX Dual Knit Mesh will be offered in various configurations which may include a rectangular sheet, anterior repair system and posterior repair system.

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KOrI503
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# INDICATIONS FOR USE ડ.

The UGYTEX® Dual Knit Mesh is indicated for tissue reinforcement and longlasting 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.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.

The UGYTEX® Dual Knit Mesh is substantially equivalent in material, function, performance and design to the predicate UGYTEX® Mesh.

## PERFORMANCE TESTING 7.

The appropriate testing was performed to determine the performance characteristics of the mesh. The test results showed that the Sofradim UGYTEX® Dual Knit Mesh is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an image of an eagle with its wings spread, with three lines representing the eagle's body.

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

SEP 2 8 2012

Sofradim Production % Pamela Papineau. RAC Consultant to Sofradim Production Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432

Re: K051503 Trade/Device Name: UGYTEX® Dual Knit Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI, OTO, PAJ Dated: June 6, 2005 Received: June 7, 2005

Dear Ms. Papineau:

This letter corrects our substantially equivalent letter of August 5, 2005.

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 (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. Perkins

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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510(k) Number (if known):

Device Name: UGYTEX® Dual Knit Mesh

Indications For Use: _ . . . . .

The UGYTEX Dual Knit Mesh is 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 X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hypt Ruodu

Division of General, Restorative, and Neurological Devices

KOSJ503 510(k) Number_

Sofradim Production 510(k) Sofradim UGYTEX® Dual Knit Mesh June 6, 2005

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