AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

K111118 · American Medical Systems · OTP · Jul 1, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K111118
• Device Name: AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Applicant: American Medical Systems
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Jul 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement. The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

Device Story

Surgical mesh kit for transvaginal pelvic organ prolapse repair; consists of permanently implanted synthetic mesh assembly and non-implantable needle passers/surgical aids. Modification to predicate includes anterior needle passer with new handle release mechanism and adjusted tissue fixation element geometry to accommodate new needle tip. Used by surgeons in clinical settings for transvaginal placement of mesh to support pelvic floor. Device provides structural support to correct prolapse; benefits include surgical correction of vaginal wall defects.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including design verification, biocompatibility, sterilization, packaging, and product performance requirements.

Technological Characteristics

Permanently implanted synthetic mesh assembly; non-implantable needle passers; modified handle release mechanism; modified tissue fixation element geometry. Sterilization and biocompatibility standards applied.

Indications for Use

Indicated for transvaginal surgical treatment of anterior, posterior, and apical vaginal wall prolapse in patients requiring surgical mesh repair.

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 Elevate Prolapse Repair Systems with PC Coated IntePro Lite (K090713)

Submission Summary (Full Text)

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JUL - 1 2011

#### 5.3 510(k) Summary Statement (21 CFR 807.92)

Submitter:

Owner/Operator:

Manufacturing Sites:

Contact Person:

Alternative Contact:

June 29, 2011

Device Common Name:

Summary Preparation Date:

Device Trade Names:

)

Class II, 21 CFR Part 878.3300

Surgical Mesh, polymeric (OTP);

Surgical Mesh

AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite AMS Elevate 9 PC Anterior and Apical Prolapse Repair System with IntePro 6 Lite

Device Classification

Classification Name:

American Medical Systems (AMS) 10700 Bren Road West Minnetonka, MN 55343

American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55434-USA

American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55434-USA FDA Establishment Registration Number: 2183959

Sterigenics US, Inc. 7775 South Quincy Street Willowbrook, IL 60527 FDA Establishment Registration Number: 1450293

Mona Inman Senior Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Mona. [e-mail]

Laura Moen-Ftacek Principal Regulatory Affairs Specialist Telephone: [phone] Fax: [phone] Laura. [e-mail]

Mesh, surgical, gynecologic, for pelvic organ prolapse transvaginally placed (OTP)

AMS Elevate® PC Prolapse Repair System with IntePro® Lite Special 510(k) Device Modification

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# Predicate Device:

AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite (K090713)

## Indications for Use:

The indication for use for the AMS Elevate PC Prolapse Repair System has been revised from a general indication to a more specific indication based on the intended use of each mesh kit type. There is no change to the intended use of the device.

### Elevate PC Anterior & Apical Repair System

The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

#### Elevate PC Apical & Posterior Repair System

The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

### General Device Description

The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a permanentlyimplanted synthetic mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor.

The devices is identical to the predicate device AMS Elevate Prolapse Repair System with PC Coated IntePro Lite, with the following exceptions: (1) The anterior needle passer has been modified to add a release mechanism on the handle; and (2) as a result of the anterior needle passer modifications, the connection interface for the tissue fixation elements of the anterior center graft that correspond with the anterior needle passer also changed. The geometry of the internal diameter and the base of the tissue fixation elements changed slightly to accommodate the new shape of the anterior needle tip. There are no changes to the mesh design, shape, size, or material.

### Summary of Non-Clinical Testing / Statement of Equivalence:

The components of the AMS Elevate PC Prolapse Repair Systems with IntePro Lite have been subjected to testing which included design verification, biocompatibility, sterilization, packaging, and product performance requirements. The test results conclude the AMS Elevate PC Prolapse Repair Systems with IntePro Lite to be substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite.

American Medical Systems considers the product performance to be significantly equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

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

SEP 2 8 2012

K111118 Re:

> Trade/Device Name: AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite and AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: June 2, 2011 Received: June 3, 2011

Dear Ms. Inman:

This letter corrects our substantially equivalent letter of July 1, 2011.

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 (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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Perkins

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

510(K) Number (if known): K111118

Device Name: AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite

Indications for Use:

The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

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 OF NEEDED)

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| Concurrence of CDEH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K111118 |