MENTOR SUSPEND SLING

K980483 · Mentor Corp. · FTL · Apr 30, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980483
• Device Name: MENTOR SUSPEND SLING
• Applicant: Mentor Corp.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft tissue where weakness exists for the urological anatomy inclusive of the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, reconstruction of the pelvic floor, and sacro-culposuspension. It is intended for the treatment of female urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Device Story

Mentor SUSPEND™ Sling is a rectangular, polymeric surgical mesh implant; used to reinforce soft tissue in urological and vaginal procedures. Device features an aperture matrix and anti-bacterial coating. Implanted by surgeons in clinical settings to treat female urinary incontinence, urethral hypermobility, or intrinsic sphincter deficiency. Provides mechanical support to pelvic floor structures. Device is available in multiple sizes to accommodate patient anatomy.

Clinical Evidence

Bench testing only. Biocompatibility testing passed. Mechanical testing for suture pull strength confirmed the device meets design criteria.

Technological Characteristics

Material: biocompatible, segmented polyether urea urethane elastomer. Form factor: rectangular mesh with aperture matrix. Sizes: 2x4 cm, 3x5 cm, 4x7 cm. Features: anti-bacterial surface coating. Non-electronic, non-software device.

Indications for Use

Indicated for female patients requiring soft tissue reinforcement for urological/vaginal procedures, including pubourethral/bladder support, prolapse repair, pelvic floor reconstruction, and sacro-colposuspension; specifically for urinary incontinence due to urethral hypermobility 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

• GoreTex™ Reinforcement Patch
• ProteGen™ Sling

Submission Summary (Full Text)

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(805) 681-600

ني جي

Image /page/0/Picture/3 description: The image shows the logo for Mentor Corporation. The logo consists of a symbol resembling a four-pointed star with arrows at the end of each point, followed by the word "MENTOR" in bold, sans-serif font. Below "MENTOR" is the word "CORPORATION" in a smaller, sans-serif font.

Executive Offices 5425 Hollister Avenue

Santa Barbara. CA 93111

APR 3 0 1998

### 510(k) SUMMARY MENTOR SUSPEND™ SLING

This 510(k) summary of safety and effectiveness information is being submitted in
This 510(k) summary of safety and effectiveness information is being submitted in
the format ummary of salety and encies. The encoments of SMDA 1990 and 21 CFR § 807.92.

The assigned 510(k) number is: _ K980483

Submitter/ Contact Person:

Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 93111

| Telephone: | [phone] |
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| FAX: | [phone] |

April 21, 1998 Date Prepared:

## Device Name and Classification

Proprietary Name: Common Name: Classification Name: Classification:

Mentor SUSPEND™ Sling Sling Surgical mesh, polymeric Class II per 21 CFR 878.3300

### Manufacturer

Mentor Urology 601 West River Road North Minneapolis, MN 55411

# Substantial Equivalence Claim

ntial Equivalence Claim
The Mentor SUSPEND™ Sling is substantially equivalent to the GoreTex™ The Meinforcement Patch and the ProteGen™ Sling.

### Indications For Use

The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft The Mentor SOSPEND - Sing is an mapsical anatomy inclusive of the following
tissue where weakness exists in the urological and vastigal and vaginal tissue where weakless casis in the and bladder support, urethral and vaginal procedures: pubburential support and elsesses and sacro-colposuspension. It is
prolapse repair, reconstruction of the pelvice as seculting from urethral prolapse repair, reconstruction of the partinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

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#### Device Description

The Mentor SUSPEND™ Sling is rectangular in shape and will be made available in several sizes: 2 cm x 4 cm, 3 cm x 5 cm, and 4 cm x 7 cm to accomodate various patient profiles. An aperature matrix is incorporated throughout the device. The Mentor SUSPEND™ Sling is manufactured from a biocompatible, segmented polyether urea urethane elastomer. An anti-bacterial coating has been incorporated onto the surface of the device.

#### Summary of Testing

The material used in the Mentor SUSPEND™ Sling has been tested for biocompatibility and passed all tests.

The Mentor SUSPEND™ Sling was tested for suture pull strength to determine the point at which the suture would "tear" the sling. The test results showed that the Mentor SUSPEND™ Sling met the design criteria for suture pull strength.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, science, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Ms. Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation Executive Offices 5425 Hollister Avenue Santa Barbara, California 93111

Re: K980483 Mentor Suspend Sling Trade Name: Requlatory Class: II Product Code: - FTL Dated: February 6, 1998 Received: February 9, 1998

Dear Ms. Crawford:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device; subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੋ substantially equivalent determination assumes compliance with ... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Crawford

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

La M. Witten, JPh.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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980483 510(k) Number (if known):

Device Name: MENTOR SUSPEND™ Sling

Indications For Use:

(Per 21 CFR 801.109)

The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft tissue where weakness exists for the urological anatomy inclusive of the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, reconstruction of the pelvic floor, and sacro-culposuspension. It is intended for the treatment of female urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative Devices
510(k) Number: k980483

Prescription Use X OR Over-The Counter Use

(Optional Format 1-2-96)