AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM

K080185 · American Medical Systems, Inc. · OTP · Apr 10, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080185
• Device Name: AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Apr 10, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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

Device Story

AMS Elevate System is a modification of the Apogee System; consists of a permanently-implanted mesh sling assembly and non-implantable surgical instruments. Instruments serve as aids for placing the mesh sling assembly within the pelvic floor. Sling assemblies are composed of polymeric mesh or a combination of polymeric mesh and porcine dermis-derived surgical mesh. Used in clinical settings by surgeons for pelvic floor reconstruction and soft tissue reinforcement. The device provides mechanical support to weakened or ruptured connective tissues, aiding in the correction of prolapse and related anatomical defects.

Clinical Evidence

Bench testing only. Components were tested for biocompatibility and performance requirements to confirm substantial equivalence to the predicate device.

Technological Characteristics

Consists of a permanently-implanted mesh sling assembly and non-implantable surgical instruments. Materials include polymeric mesh and porcine dermis-derived surgical mesh. The device is a mechanical implant for soft tissue reinforcement.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair due to connective tissue rupture or weakness in urological, gynecological, or gastroenterological anatomy, including pubourethral support, vaginal wall prolapse repair, vaginal suspension, and pelvic floor reconstruction.

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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K080185

#### 5.3 510(k) Summary Statement

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

## Indications for Use

The 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, 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 System is a modification of the Apogee System, part of the AMS Pelvic Floor Repair System family of devices. It consists of a permanently-implanted mesh sling assembly and non-implantable surgical instruments that can be used as aids to place the mesh sling assembly in the pelvic floor. The sling assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from porcine dermis.

### Summary of Testing

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

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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 caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

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

SEP 2 8 2012

American Medical Systems (AMS) % Ms. Mona Inman 10700 Bren Road West Minnetonka, MN 55343

Re: K080185

Trade/Device Name: AMS Elevate™ with IntePro® Lite™ Prolapse Repair System AMS Elevate™ with InteXen® LP Prolapse Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: March 12, 2008 Received: March 13, 2008

Dear Ms. Inman:

This letter corrects our substantially equivalent letter of April 10, 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/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/ReportalProblem/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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#### Indications for Use 5.2

# Indications for Use

510(k) Number (if known):

K080185

Device Names:

AMS Elevate™ with IntePro® Lite™ Prolapse Repair System AMS Elevate™ with InteXen® LP Prolapse Repair System

Indications For Use:

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

Prescription Use × (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 NEEDED)

Neil A.P. Ogden for

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

AMS Elevater Prolaps 194455 Number Special 510(k) Device Modification

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