AMS MALE TRANSOBTURATOR SLING SYSTEM

K053371 · American Medical Systems, Inc. · OTM · Feb 3, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053371
• Device Name: AMS MALE TRANSOBTURATOR SLING SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: OTM · General, Plastic Surgery
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant for the treatment of male stress urinary incontinence (SUI).

Device Story

AMS Male Transobturator Sling System consists of a polymeric mesh sling and a surgical needle instrument (Needle Passer). Used by physicians in a surgical setting to treat male stress urinary incontinence via a transobturator approach. The sling provides sub-urethral support to restore continence. The needle passer facilitates precise placement of the mesh through the obturator foramen. The device is a mechanical implant; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

Evidence includes bench testing, biocompatibility testing, cadaver studies, and a literature review. No specific clinical trial metrics (e.g., sensitivity, specificity) are provided in the summary.

Technological Characteristics

Polymeric mesh sling with resorbable sutures; surgical needle instrument (Needle Passer). Mechanical device; no energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for male patients with stress urinary incontinence (SUI) requiring a sub-urethral sling implant.

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

• Short Shaft Straight-In Bone Fixation System (InVance) (K982155)
• Monarc Subfascial Hammock (K023516)
• Sparc Sling System (K011251)
• Apogee (K040537)
• Perigee (K040623)

Submission Summary (Full Text)

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#### 510(k) Summary Statement న్.

| Submitter: | American Medical Systems (AMS)<br>10070 Bren Road West<br>Minnetonka, MN 55343<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Frank B. Freedman, Ph.D. |
| Device Common Name: | Sub-Urethral Sling System; Surgical Mesh |
| Device Trade Name: | AMS Male Transobturator Sling System |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Devices: | Short Shaft Straight-In Bone Fixation System (trade<br>name "InVance) (K982155)<br>Monarc Subfascial Hammock (K023516),<br>Sparc Sling System (K011251),<br>Apogee (K040537),<br>Perigee (K040623) and other devices |

# Device Description

The AMS Male Transobturator Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement using a transobturator approach. The slings are made from polymeric mesh and have resorbable sutures.

### Indications for Use

The AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant for the treatment of male stress urinary incontinence (SUI).

### Comparison to Predicate Devices

The AMS Male Transobturator Sling System provides physicians an alternative surgical approach to implant sub-urethral slings to treat male stress urinary incontinence. The AMS Male Transobturator Sling material, design and characteristics are substantially equivalent to those exhibited by Monarc, Sparc, Apogee, Perigee and other surgical meshes cleared for commercial distribution. The materials, design and characteristics of the AMS Male Transobturator Surgical Needle Instrument (also called "Needle" and *Needle Passer'') used for sling placement are substantially equivalent to those embodied in the Monarc Subfascial Hammock Needle Passer and other surgical instruments cleared for commercial distribution.

### Supporting Information

Substantial equivalency was supported by previously cleared and new bench and biocompatibility testing, cadaver studies, clinical data and a literature review.

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Public Health Service

2006 FEB 3

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Frank B. Freedman, Ph.D. Senior Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, Minnesota 55343

Re: K053371

Trade/Device Name: AMS Male TO Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 5, 2006 Received: January 6, 2006

Dear Dr. Freedman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. or re-s) Fe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierels 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 such 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 or any v with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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## Page 2 - Dr. Freedman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial «quivalence 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Loubac Buelup

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Ko53371

Device Name: AMS Male TO Sling System

Indications For Use: The AMS Male Transobturator Sling System is indicated for a suburethral sling implant to treat male stress urinary incontinence.

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

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

(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

bare Bucklin

(Division Sign Division of General. Restorative, and Neurological Devices

**510(k) Number** K05337