AMS SMART SLING SYSTEM

K063713 · American Medical Systems, Inc. · OTN · Feb 22, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063713
• Device Name: AMS SMART SLING SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Feb 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

AMS Smart Sling System comprises polymeric mesh sling and surgical needle instrument (Needle Passer); used for sub-urethral sling placement to treat female stress urinary incontinence (SUI). Device utilized by physicians in clinical settings. Sling provides mechanical support to urethra; needle instrument facilitates precise placement of mesh. System offers alternative surgical approach for SUI management; intended to restore urethral support and improve patient continence. Substantial equivalence established via bench testing, biocompatibility assessment, cadaver studies, and literature review.

Clinical Evidence

No clinical trials; evidence based on bench testing, biocompatibility testing, cadaver studies, and literature review.

Technological Characteristics

Polymeric mesh sling; surgical needle instrument (Needle Passer). Class II device (21 CFR 878.3300).

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

• Caldera "T" Sling (K050516)
• MonarcTM Subfascial Hammock (K023516)
• SparcTM Sling System (K011251)

Submission Summary (Full Text)

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#### ડ. 510(k) Summary Statement

FEB 2 2 2007

| Submitter: | American Medical Systems (AMS)<br>10070 Bren Road West<br>Minnetonka, MN 55343<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brad Onstad |
| Device Common Name: | Sub-Urethral Sling System; Surgical Mesh |
| Device Trade Name: | AMS Smart Sling System |
| Device Classification Name: | Surgical Mesh, polymeric (OTN) |
| Predicate Devices: | Caldera "T" Sling (K050516),<br>MonarcTM Subfascial Hammock (K023516),<br>SparcTM Sling System (K011251) |

#### Device Description

The AMS Smart Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement. The slings are made from polymeric mesh.

#### Indications for Use

The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

## Comparison to Predicate Devices

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

## Supporting Information

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

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

Mr. Brad Onstad Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K063713 Trade/Device Name: AMS Smart Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: December 14, 2006 Received: December 14, 2006

Dear Mr. Onstad:

This letter corrects our substantially equivalent letter of February 22, 2007.

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/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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# Indications for Use

510(k) Number (if known):

Device Name: AMS Smart Sling System

Indications For Use: The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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

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

K663713

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

Mark A. Milliken

(Division Sign-Off) Division of General, Testorative, and Neurological De . . ces

510(k) Number

111 化663717