URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM

K041176 · Sofradim Production · OTN · May 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041176
• Device Name: URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
• Applicant: Sofradim Production
• Product Code: OTN · General, Plastic Surgery
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The URETEX® TO Trans-Obturator Urethral Support System is indicated for the treatment of stress urinary incontinence from urethral hyper mobility and/or intrinsic sphincter deficiency.

Device Story

URETEX SUP/TO is a pubourethral sling system for treating female stress urinary incontinence. Device consists of a polypropylene monofilament mesh tape, insertion instrument (stainless steel needle with PVC tubing), connector, and sheath. Used in gynecological surgical procedures; operated by physicians. Implanted to provide suburethral support, reinforcing tissue to address urethral hypermobility or intrinsic sphincter deficiency. Single-use device.

Clinical Evidence

Bench testing only. Performance characteristics including density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength were evaluated and compared to predicate devices (Ethicon Prolene®, Sofradim Parietene®). Results demonstrated similar performance to predicates.

Technological Characteristics

Polypropylene sealed monofilament mesh; stainless steel needle with PVC tubing; single-use; sterile. Evaluated per ISO standards for mechanical properties including tensile strength, burst resistance, and tear resistance.

Indications for Use

Indicated for women with stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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

• Ethicon TVT (K974098)
• Sofradim Parietene® Meshes (K991400)
• Mentor Sling (K980483)

Submission Summary (Full Text)

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K041176
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## 510(k) Summary For the Sofradim Production URETEX SUP® Pubourethral Sling and Instruments

#### SPONSOR 1.

Sofradim Production 116 avenue du Formans 01600 Trevoux France

MAY 1 7 2004

Contact: Patrice Becker Telephone: [phone] (0)4 74 08 90 02 Facsimile:

#### DEVICE NAME 2.

URETEX SUP® Device Proprietary Name: Common/Usual Name: Surgical Mesh Classification Namc: Surgical Mesh

#### PREDICATE DEVICES 3.

K974098 Ethicon TVT Sofradim Parietene® Meshes K991400 Mentor Sling K980483

#### 4. DEVICE DESCRIPTION

The URETEX® SUP Pubourethral Sling is used in gynecological procedures for the treatment of stress incontinence. The URETEX® SUP device is made from polypropylene sealed monofilament stitches (tape). It is composed of an insertion instrument, connector, sheath, and the pubourethral implant. The insertion instrument consists of a stainless steel needle with PVC tubing.

#### ડ. INTENDED USE

The URFTEX® SUP device is indicated for the treatment of stress urinary incontinence in women.

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K041176
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### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The URETEX® SUP Polypropylene Mesh is substantially equivalent to the T.V.T. Ethicon Prolene Pubourethral Tape, the Sofradim Parietene® Mesh, and the Mentor Sling Device.

The URETEX® SUP Polypropylene Mesh and the TVT device have the same intended use in that they are all used for treatment of stress urinary incontinence as well as reinforcement of tissue during surgical repair.

The URETEX SUP, the TVT Ethicon (Prolene® mesh), the Mentor Sling and the Parietene® Polypropylenc Mesh are all made from polypropylenc sealed monofilament stitches. All of the devices arc single-use only.

#### PERFORMANCE TESTING r.

Testing was performed in accordance with ISO standards. The density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength were evaluated to determine the performance characteristics of the Pubourethral Sling. All of the testing was performed using the URETEX® SUP Sling, the Ethicon Prolenc®, and the Solradim Parietene® prodicate devices for comparative purposes. The test results showcd that the Sofradim and predicate devices were similar in performance characteristics.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

Sofradim Production % Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

SEP 28 2012

Re: K041176 Trade/Device Name: URETEX® TO Trans-Obturator Urethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: May 4, 2004 Received: May 5, 2004

Dear Ms. McNamara-Cullinane:

This letter corrects our substantially equivalent letter of May 17, 2004.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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# K 041176

## Indications for Use

510(k) Number (if known):

Device Name: URETEX® TO Trans-Obturator Urcthral Support System

Indications For Use:

The URETEX® TO Trans-Obturator Urethral Support System is indicated for the treatment The Order in Creatinence from urethral hyper mobility and/or intrinsic sphincter deficiency.

X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Usc (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER PAGE IF NEEDF.OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________