AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH

K002721 · American Medical Systems, Inc. · FTL · Nov 29, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K002721
• Device Name: AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
• Applicant: American Medical Systems, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 29, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMS Triangle™ 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 procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Device Story

The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is a permanent surgical implant designed for soft tissue reinforcement and treatment of urinary incontinence. The device consists of a polyester mesh substrate coated with a thin layer of solid silicone elastomer. It is available in various dimensions ranging from 2 cm x 4 cm to 12 cm x 12 cm. The device is intended for use by surgeons in clinical or operating room settings to provide mechanical support for weakened tissues in the pelvic floor, urethra, vagina, or rectum. By providing a stable scaffold, the mesh reinforces anatomical structures, thereby addressing prolapse or incontinence. The device is implanted surgically; it functions as a passive structural support rather than an active or electronic system.

Clinical Evidence

Bench testing only. The device demonstrated biocompatibility and physical equivalence to predicate devices regarding tensile strength and suture pull strength. No clinical data provided.

Technological Characteristics

Polyester mesh substrate coated with a thin layer of solid silicone elastomer. Available in multiple sizes (e.g., 2x5 cm to 12x12 cm). Passive implantable device. No energy source or software components.

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 pelvic floor reconstruction, prolapse repair, and sacral-colposuspension.

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

• TriAngleTM Sling (K980482)
• Bard® Marlex Mesh (K922916)
• Ethicon™ Prolene™ Mesh (K962530)
• Mersilene™ Mesh
• Mentor SUSPEND™ Sling (K980483)

Submission Summary (Full Text)

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# NOV 2 9 2000

## 510(k) Summary AMS Triangle™ Silicone-Coated Sling and Surgical Mesh 510(k) Number K002721

### Submitter/Contact Person:

Ginger Sackett Glaser Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343

Phone: [phone] Fax: [phone] Email: ginger [e-mail]

### Device Name and Classification:

Trade Name: AMS Triangle™ Silicone-Coated Sling and Surgical Mesh Common/Usual Name: Surgical Mesh, Sling, Urethral Sling Classification Name: Surgical Mesh, polymeric Product Code: FTL Classification: Class II

### Manufacturing Location:

American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343

### Predicate Devices:

TriAngleTM Sling - K980482 Bard® Marlex Mesh - K922916 Ethicon™ Prolene™ Mesh - K962530 Mersilene™ Mesh Mentor SUSPEND™ Sling - K980483

#### Indications for Use:

The AMS Triangle™ 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 procedures: pubourethral support and bladder support, urethral and vaginal prolapse publication and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

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#### Device Description:

The AMS Triangle™ Siliconc-Coated Sling and Surgical Mesh is made of a The AMS THangle - Omeone with a thin layer of solid silicone elastomer. The polyester mesil that is obverted the Sling and Surgical Mesh is available in sizes AMO Triangle - Binoo.144 cm2, including 2 cm x 5 cm, 2 cm x 4 cm, 2 cm x 10 cm, 2 cm x 7 cm, 2 cm x 20 cm, 6 cm x 6cm and 12 cm x 12cm.

# Summary of Testing

The material used in the AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been demonstrated to be biocompatible.

The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been I ne Ario Trange of physical characteristics including tensile strength and suture pull strength and has been shown to be equivalent to the listed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2000

Ms. Ginger S. Glaser *Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West Minnetonka, Minnesota 55343

K002721 Re:

> Trade Name: AMS Triangle Silicone-Coated Sling and Surgical Mesh

Regulatory Class: II Product Code: FTL Dated: August 24, 2000 Received: August 31, 2000

Dear Ms. Glaser:

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 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 (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. A 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 regulation may result in regulatory 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 obligation 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. Ginger S. Glaser

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow your to other substantial equivalence of your device to a premarket notification. - The PDF 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 -II you desire specific as for in vitro diagnostic devices), please contact the Office of and additionally 6091794-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. ad vertibing of your a regulation entitled, "Misbranding by reference to premarket Also, prease note togation of ther 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,

Sincerely yours,

Mark N Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:_AMS Triangle Silicone-Coated Sling and Surgical Mesh

Indications For Use:

The AMS Triangle™ 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 procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

to Mark N Milliner

(Division Sign-Off) Division of General Restorative Dev 510(k) Number.