TOPAS SYSTEM

K070993 · American Medical Systems, Inc. · FTL · May 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070993
• Device Name: TOPAS SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and postcrior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

Device Story

TOPAS System comprises surgical needles and mesh; used for pelvic floor repair and soft tissue reinforcement. Device facilitates surgical procedures including urethral slings for incontinence, vaginal wall prolapse repair, and pelvic floor reconstruction. Operated by surgeons in clinical/surgical settings. Mesh provides structural support to weakened or ruptured connective tissue; needles assist in precise placement of mesh during implantation. Benefits include restoration of anatomical support and treatment of pelvic floor dysfunction.

Clinical Evidence

Bench testing only. Biocompatibility and performance requirements were evaluated and found to be substantially equivalent to the predicate device.

Technological Characteristics

System consists of surgical mesh and needles. Polymeric surgical mesh (Class II, 21 CFR 878.3300). Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients requiring connective tissue repair or soft tissue reinforcement in urological, gynecological, or gastroenterological anatomy, including treatment for incontinence, vaginal wall prolapse, vaginal suspension, 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

• Apogee™ System, Part of the AMS Pelvic Floor System (K051485)

Submission Summary (Full Text)

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Repair

### 2.3 510(k) Summary Statement

| Submitter: | American Medical Systems (AMS)<br>10700 Bren Road West<br>Minnetonka, MN 55343 |
|------------------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Sarah Peterson<br>Phone: [phone]<br>Fax: [phone] |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | TOPASTM System |
| Device Classification/<br>Classification Name: | Class II, 21 CFR Part 878.3300<br>Surgical Mesh, polymeric (FTL) |
| Predicate Device: | Apogee™ System, Part of the AMS Pelvic Floor<br>System (K051485) |

## Indications for Use

AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and postcrior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

### Device Description

The TOPAS™ System consists of needles and mesh used to repair the connective and soft tissue in the pelvic floor.

# Summary of Testing

The components of the TOPAS™ System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

American Medical Systems, Inc. % Ms. Sarah Peterson Regulatory Specialist 10700 Bren Road West Minnetonka, Minnesota 55343

MAY - 9 2007

Re: K070993

Trade/Device Name: TOPAS™ System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 6, 2007 Received: April 9, 2007

Dear Ms. Peterson:

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 application (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 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 comply 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 – Ms. Sarah Peterson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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" (21CFR 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.

Mark N. Molkerson

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

Enclosure

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K070993

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#### 2.2 Indications for Use

510(k) Number (if known): K8570993

Device Name: TOPAS™ System

Indications For Use: AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

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-CONTINUE ON ANOTHER PAGE IF NEEDED)

Division of General. Restorative. and Neurological Devices

*10(k) Number / L670993