AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

K082677 · American Medical Systems, Inc. · OTP · Dec 23, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082677
• Device Name: AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Dec 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The AMS Elevate 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

Device Story

AMS Elevate Anterior and Apical Prolapse Repair System is a surgical mesh device for pelvic floor reconstruction. It consists of a permanently implanted knitted polymeric mesh assembly and non-implantable surgical instruments used to facilitate mesh placement. The device is used by surgeons in a clinical/surgical setting to reinforce weakened soft tissues or repair ruptured connective tissue. The mesh provides structural support to the pelvic floor anatomy. It is a modification of the AMS Pelvic Floor Repair System (Perigee).

Clinical Evidence

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

Technological Characteristics

Knitted polymeric surgical mesh; permanently implanted; non-implantable surgical instruments included for placement; Class II device (21 CFR 878.3300).

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of ruptured connective tissue in urological, gynecological, and gastroenterological anatomy, including pelvic floor reconstruction, vaginal suspension, and urethral slings.

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

• AMS Pelvic Floor Repair System (K051485)

Submission Summary (Full Text)

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#### 510(k) Summary Statement 5.3

# DEC 2 3 2008

| Submitter: | American Medical Systems (AMS)<br>10700 Bren Road West<br>Minnetonka, MN 55343 | |
|------------------------|--------------------------------------------------------------------------------|--|
| Contact Person: | Mona Inman | |
| | Phone: [phone] | |
| | Fax: [phone] | |
| Device Common Name: | Surgical Mesh | |
| Device Trade Names: | AMS Elevate™ Anterior and Apical Prolapse Repair<br>System with IntePro® Lite™ | |
| Device Classification/ | Class II, 21 CFR Part 878.3300 | |
| Classification Name: | Surgical Mesh, polymeric (OTP) | |
| Predicate Device: | AMS Pelvic Floor Repair System (K051485) | |

### Indications for Use

The AMS Elevate 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

## Device Description

The AMS Elevate Anterior and Apical Prolapse Repair System is a modification of the Perigee System, part of the AMS Pelvic Floor Repair System family of devices. It consists of a permanently-implanted mesh assembly and non-implantable surgical instruments that can be used as aids to place the mesh assembly in the pelvic floor. The mesh assembly is made from knitted polymeric mesh.

## Summary of Testing

The components of the AMS Elevate Anterior and Apical Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.

#### 5.4 Standard Data Report for 510(k)s

Standard Data Reports for 510(k)s (Form FDA 3654) are attached in Appendix E.

AMS Elevate™ Anterior & Apical Prolapse Repair System Special 510(k) Device Modification

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Image /page/1/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 three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white.

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

American Medical Systems, Inc. % Ms. Mona Inman Senior Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K082677

> Trade/Device Name: AMS Elevate™ Anterior and Apical Prolapse Repair System with IntePro® Lite™ Regulation Number: 21 CFR 878.3300

Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: November 26, 2008 Received: November 28, 2008

Dear Ms. Inman:

This letter corrects our substantially equivalent letter of December 23, 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

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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 (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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Benjamin R. Fuchs

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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#### 5.2 Indications for Use

# Indications for Use

510(k) Number (if known):

Device Names:

AMS Elevate™ Anterior and Apical Prolapsc Repair System with IntePro® Lite™

Indications For Use:

The AMS Elevate 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
|-------------------------------------------------|---|--------|------------------------------------------------|--|

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

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

AMS Elevate
^TM Anterior & Apical (Prolapse) Repair System

| 510(k) Number | K082627 |
|------------------------------------|---------|
| Special 510(k) Device Modification | |

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