AMS MINIARC SLING SYSTEM

K073703 · American Medical Systems, Inc. · PAH · Jan 30, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073703
• Device Name: AMS MINIARC SLING SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Jan 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

AMS MiniArc Sling System is a surgical device for suburethral sling placement to treat female stress urinary incontinence. System comprises a polymeric mesh sling and a specialized surgical instrument, the 'Needle Passer'. Used by surgeons in a clinical/surgical setting. The device provides mechanical support to the urethra to address hypermobility or intrinsic sphincter deficiency. It is a modification of the predicate MiniArc Sling System.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Polymeric mesh sling; surgical instrument (Needle Passer) for placement. Class II device, 21 CFR 878.3300, Product Code PAH.

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

• MiniArc Sling System (K071902)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a handwritten string of characters, which appears to be a code or identifier. The characters are 'K073703', written in a cursive style. The writing is in black ink on a white background, and the characters are easily readable.

#### 5.3 510(k) Summary Statement

| Submitter: | American Medical Systems (AMS)<br>10700 Bren Road West<br>Minnetonka, MN 55343 |
|------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Brad Onstad<br>Phone: [phone]<br>Fax: [phone] |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | AMS MiniArc™ Sling System |
| Device Classification: | Class II, 21 CFR Part 878.3300 |
| Classification Name: | Surgical Mesh, polymeric (PAIt) |
| Predicate Device: | MiniArc Sling System (K071902) |

### Indications for Use

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

### Device Description

The AMS MiniArc Sling System is a modification of MiniArc Sling System consisting of a sling and a surgical instrument (called a "Needle Passer") for suburethral sling placement. The slings are made from polymeric mesh.

### Summary of Testing

The components of the AMS MiniArc Sling System have been tested for performance requirements and found to be substantially equivalent to the predicate device.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

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

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

SEP 2 8 2012

Re: K073703 Trade/Device Name: AMS MiniArc Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: December 28, 2007 Received: December 31, 2007

Dear Mr. Onstad:

This letter corrects our substantially equivalent letter of January 30, 2008.

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

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

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Nichols

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### 5.2 Indications for Use

# Indications for Use

## 510(k) Number (if known):

AMS MiniArc Sling System Device Name:

Indications For Use:

The AMS MiniArc Sling System is intended for the placement of a suburethral 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)

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

(Division Staff)
Division of Cervical, Restorative
and Neurological Devices

Division of Surgical, Restorative
and Neurological Devices

510(k) Number
K073203

AMS MiniArc The Sling System Special 510(k) Labeling Modification Page 19 of 39