MENTOR OBTAPE TRANS-OBTURATOR TAPE

K031767 · Mentor Corp. · OTN · Jul 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031767
• Device Name: MENTOR OBTAPE TRANS-OBTURATOR TAPE
• Applicant: Mentor Corp.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

Mentor ObTape is an implantable, non-woven polypropylene suburethral support tape; used for surgical treatment of female stress urinary incontinence (SUI). Device includes disposable and re-usable introducer needles for implantation. Tape provides mechanical support to the urethra to address hypermobility or intrinsic sphincter deficiency. Used in surgical settings by physicians. Benefits include restoration of urinary continence through physical support of the urethra.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing for mechanical properties (tear strength, tensile strength, elongation) per EDANA standards and biocompatibility testing per USP, ISO 10993, and EN standards.

Technological Characteristics

Material: Non-woven polypropylene fibers. Form factor: Implantable tape with introducer needles. Mechanical testing: Complies with EDANA standards. Biocompatibility: Complies with USP, ISO 10993, and EN standards.

Indications for Use

Indicated for female patients with stress urinary incontinence (SUI) caused by 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

• Johnson and Johnson's Tension Free Vaginal Tape (TVT) System (K974098)
• American Medical Systems' Sparc Sling System (K013355)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUL 1 7 2003

K031767\$\rho_{1/2}\$

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: ---------------------------------------------------------------

| Contact Person: | Donna A. Crawford<br>Director, Corporate Regulatory Affairs<br>Mentor Corporation<br>201 Mentor Drive<br>Santa Barbara, CA 93111 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 805-879-6304 |
| FAX: | 805-879-6015 |
| Date Prepared: | June 6, 2003 |

# Device Name and Classification

| Proprietary Name: | Mentor ObTape Trans-obturator Tape and Introducers |
|----------------------|----------------------------------------------------|
| Common Name: | Pubourethral Support Sling |
| Classification Name: | Surgical Mesh, polymeric |
| Class: | Class II |
| Product Code: | OTN |
| CFR #: | §878.3300 |

## Device Description

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

ObTape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, tissue colonization and facilitates positioning during surgery. Disposable and re-usable Introducer Needles necessary for the implantation are also available with the device.

Similar to Johnson and Johnson's Tension Free Vaginal Tape (TVT) System cleared under 510(k) No: K974098 and American Medical Systems' Sparc Sling System cleared under 510(k) K013355, ObTape will be manufactured from polypropylene material.

#### Substantial Equivalence Claim

The Mentor ObTape Trans-obturator Tape is substantially equivalent in material, function, performance and design to the urethral support tape products manufactured and marketed by Johnson & Johnson, 510(k) No: K974098 and American Medical Systems, 510(k) K013355.

{1}------------------------------------------------

K031767\$*{P*{2/2}}\$

# Indications for Use

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

# Summary of Testing

All mechanical testing specifications comply with established EDANA standards for Tear Strength, Tensile Strength, and Elongation.

All biocompatibility testing comply with established USP, ISO 10993 or EN standards for Cytotoxicity, Genotoxicity, Hemolysis, Implantation, Pyrogenicity, Intracutaneous, Sensitization, and Systemic Toxicity.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Ms. Donna Crawford Director, Corporate Regulatory Affairs Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

SEP 2 8 2012

Re: K031767 Trade/Device Name: Mentor ObTape Trans-obturator Tape and Introducers Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: June 6, 2003 Received: June 10, 2003

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of July 17, 2003,

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

{3}------------------------------------------------

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. 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

{4}------------------------------------------------

# K 021767

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Mentor ObTape Trans-obturator Tape and Introducers

Indications for Use:

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over the Counter Use

(Per CFR 801.109)

(Optimal Format 1-2-96)

Miriam C. Provost

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

510(k) Number K031767