PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM

K090934 · American Medical Systems, Inc. · FTL · Jun 2, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090934
• Device Name: PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jun 2, 2009
• 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 posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

Device Story

PFR Sling System is a sterile, single-use surgical kit; consists of stainless steel curved needle passers and an implantable mesh assembly. Used by surgeons in clinical settings for pelvic floor reconstruction and soft tissue reinforcement. Device provides mechanical support to weakened or ruptured connective tissues. Benefits include restoration of anatomical structure and treatment of incontinence. No complex data processing or software involved.

Clinical Evidence

Bench testing only; biocompatibility and performance requirements met.

Technological Characteristics

Sterile, single-use kit. Components include stainless steel curved needle passers and an implantable mesh assembly. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or connective tissue repair in urological, gynecological, and 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

• PFR Sling System (K070993)

Submission Summary (Full Text)

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# 510(k) Summary Statement

| Submitter: | American Medical Systems (AMS)<br>10700 Bren Road West<br>Minnetonka, MN 55343 |
|------------------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Sarah J.P. Meyer<br>Phone: [phone]<br>Fax: [phone] |
| | JUN - 2 2005 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | PFR Sling System, Part of the AMS Pelvic Floor<br>Repair System |
| Device Classification/<br>Classification Name: | Class II, 21 CFR Part 878.3300<br>Surgical Mesh, polymeric (FTL) |
| Predicate Device: | PFR Sling System (K070993), Part of the AMS<br>Pelvic Floor Repair 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.

#### Device Description

The PFR Sling System is a sterile, single use procedure kit that consists of stainless steel, curved needle passers and an implantable mesh assembly.

## Summary of Testing

The components of the PFR Sling System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 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 black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN - 2 2009

American Medical Systems, Incorporation % Ms. Sarah Meyer Senior Regulatory Specialist 10700 Bren Road, West Minnetonka, Minnesota 55343

Re: K090934

Trade/Device Name: PFR Sling System, Part of the AMS Pelvic Floor Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: May 6, 2009 Received: May 7, 2009

Dear Ms. Meyer:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing

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Page 2- Ms. Sarah Meyer

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/cdrh/comp/ 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" (21CFR 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Rra. Robl

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K090934

# Indications for Use Statement

| 510(k) Number:<br>(if known) | K090934 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PFR Sling System, Part of the AMS Pelvic Floor<br>Repair System |
| Indications For Use: | AMS Pelvic Floor Repair System is intended for use<br>where the connective tissue has ruptured or for<br>implantation to reinforce soft tissues where weakness<br>exists in the urological, gynecological and<br>gastroenterological anatomy. This includes but is not<br>limited to the following procedures: pubourethral<br>support, including urethral slings for the treatment of<br>incontinence, vaginal wall prolapse repairs including<br>anterior and posterior wall repairs, vaginal<br>suspension, reconstruction of the pelvic floor and<br>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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krone for MxM

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090934 35 of 72

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