AMS SACRAL COLPOPEXY SLING, MODEL 72403501

K010931 · American Medical Systems, Inc. · OTO · Apr 9, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K010931
• Device Name: AMS SACRAL COLPOPEXY SLING, MODEL 72403501
• Applicant: American Medical Systems, Inc.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Apr 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMS Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following t procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacralcolposuspension.

Device Story

Implantable surgical mesh/sling; used for soft tissue reinforcement and urinary incontinence treatment. Device consists of silicone-coated mesh configured in a Y-shape (Sacral Colpopexy Sling) or standard sling form. Implanted by surgeons in clinical settings to support pelvic floor, urethra, or rectum. Provides mechanical reinforcement to weakened anatomical structures. Benefits include restoration of pelvic support and treatment of incontinence. Device is purely mechanical; no electronic or software components.

Clinical Evidence

Bench testing only. Mechanical properties of the Y-configuration were tested to confirm performance specifications. Biocompatibility of the bonding material was demonstrated.

Technological Characteristics

Silicone-coated surgical mesh; Y-shaped configuration; adhesive used for Y-bond; mechanical implant; non-electronic; non-software.

Indications for Use

Indicated for patients with urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency (ISD), and for soft tissue reinforcement in urological, gynecological, or gastroenterological procedures, including pubourethral/bladder support, prolapse repair, and pelvic floor reconstruction.

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

• AMS Silicone-Coated Sling and Surgical Mesh (K002721)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

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

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SEP 2 8 2012

Ms. Elsa A. Linke Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

Re: K010931 Trade/Device Name: AMS Silicone-Coated Sling and Surgical Mesh

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: March 27, 2001 Received: March 28, 2001

Dear Ms. Linke:

This letter corrects our substantially equivalent letter of April 9, 2001.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/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 ENCLOSURE

# Kolog3)

510(k) Number:

Device Name:

Indications for Use:

AMS Silicone-Coated Sling and Surgical Mesh

The AMS Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following t procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacralcolposuspension.

Miriam C. Provost

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

510(k) Number K61093/

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices

510(k) Number

Prescription Use V (Per 21 CFR801.109)

OR

Over the Counter Use

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# APR = 9 2001

## 510(k) SUMMARY

Submitter's Name:

Address:

Tel:

Fax:

American Medical Systems, Inc.

p. 1/2

10700 Bren Road West Minnetonka, MN 55343

952-933-4666

952-930-6157

Elsa A. Linke

March 27, 2001

Surgical Mesh, Sling

Classification: Class II Product Code: FTL

AMS Sacral Colpopexy Sling

Contact Person:

Date of Summary Preparation:

Device Common Name:

Device Trade Name:

Device Classification Name:

Predicate Device:

AMS Silicone-Coated Sling and Surgical Mesh K002721

Surgical Mesh, polymeric (21 CFR 878.3300)

#### Device Description

The AMS Sacral Colpopexy Sling is an alternate version of the AMS Silicone-Coated Sling and Surgical Mesh. The two slings are exactly the same except for the fact that the Sacral Colpopexy Sling is in the shape of a Y.

#### Indications for Use

The AMS Sacral Colpopexy Sling is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacralcolposuspension.

#### Comparison to Predicate Device

The fundamental scientific technology of the device will not change with the proposed alternative configuration of the device. With the exception of adding an adhesive to form the y-bond, the material characteristics of the device remain the same as in the predicate. The addition of a short arm of sling mesh is the only change to the physical characteristics.

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K010931 p. 2/2

[510(k) Summary continued]

## Supporting Information

The mechanical properties of the new y-configuration of the sling have been tested on the bench and shown to meet performance specifications. In addition, the bonding material has been demonstrated to be biocompatible.

## Conclusion

The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics.