AMS ELEVATE PC

K112842 · American Medical Systems, Inc. · OTP · Oct 25, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K112842
• Device Name: AMS ELEVATE PC
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Oct 25, 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

AMS Elevate PC Prolapse Repair Systems consist of IntePro Lite surgical mesh assembly and non-implantable needle passers/surgical aids. Used for transvaginal placement of mesh in pelvic floor to correct prolapse. Operated by surgeons in clinical settings. Device provides structural support to pelvic organs. Modification involves changes to apical needle passer sheath; mesh design, material, and indications remain identical to predicate. System facilitates surgical repair of vaginal wall and apical prolapse.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Surgical mesh kit including polymeric mesh and needle passers. Materials and mesh design are identical to predicate. Sterilization via validated methods. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring transvaginal surgical treatment for anterior or posterior vaginal wall prolapse and vaginal apical prolapse.

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 PC Anterior and Apical Prolapse Repair System with IntePro Lite (K111118)
• AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite (K111118)

Submission Summary (Full Text)

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OCT 2 5 2011 K112842
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## Section 6

## 510(k) Summary [21 CFR 807.92]

#### Submitter's Name and Address

Matthew D. Stepanek Senior Regulatory Affairs Specialist American Medical Systems, Inc. 952-939-7023 (telephone) 952-930-5785 (fax) [e-mail]

## Alternate Contact Name and Information

Josh Clarin Regulatory Affairs Manager American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7072 (telephone) 952-930-5785 (fax) [e-mail]

#### Date the Summary was Prepared

September 27, 2011

#### Device Classification Names

Surgical Mesh, polymeric Mesh, surgical, gynecologic, for pelvic organ prolapse transvaginally placed

## Device Common/Usual Name

Surgical Mesh

### Device Trade/Proprietary Name

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

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K112842
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## Product Codes

## FTL and OTP

## Classification of Device

Class II 21 CFR Part 878.3300

## Predicate Device(s)

| Device Name | Submission Number | Clearance Date |
|---------------------------------------------------------------------------------|-------------------|----------------|
| AMS Elevate PC Anterior and Apical Prolapse Repair System<br>with IntePro Lite | K111118 | July 1, 2011 |
| AMS Elevate PC Apical and Posterior Prolapse Repair System<br>with IntePro Lite | | |

## Device Description

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

The devices are identical to the predicate device AMS Elevate PC Prolapse Repair The devilous are noonidate with the following exception of the modification of the Apical Needle Passer Sheath. There are no changes to the mesh design, shape, size, material or Indications for Use.

## Existing Indication for Use & Proposed Indication for Use

There are no changes to the existing indications for use. Indications for the predicate and modified devices are as follows:

## 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.

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# Summary of the Technological Characteristics to the Predicate Device(s)

The modifications to the predicate devices are deemed equivalent and there are no The modifications to the predications, device indications for use/intended use and/or device functional scientific technology.

The subject devices use the same surgical approach and mesh placement procedures as the predicate devices.

## Summary of Non-Clinical Testing

The components of the AMS Elevate PC Anterior and Apical Prolapse Repair Systems The Components of the AMO Elevate PC Apical and AMS Elevate PC Apical and Posterior with Inter IO Lite (Elevate TO Alikonor) and Pillo Clevate PC Posterior) have best results r rolupor Repair Oyotene minitiation, and packaging. The test results for design vehiloation, olooompans.ity, equivalent to the predicate device.

## Substantial Equivalence

The modified Elevate PC Anterior and Elevate PC Posterior devices use the same surgical approach and mesh placement procedures as the predicate device.

The proposed Elevate PC Anterior and Elevate PC Posterior devices have identical indications for usefintended use, identical implant materials, identical sterilization methods; and similar delivery tool materials/characteristics as the predicate.

The proposed Elevate PC Anterior and Elevate PC Posterior device performance and fundamental scientific technology remains unchanged. The differences between the proposed device and the predicate device does not have any negative effect on the safety and effectiveness of the device.

### Conclusion

AMS considers the modified Elevate PC Anterior and Elevate PC Posterior devices to be substantially equivalent to the predicate devices.

### Manufacturing Facility

American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343

Establishment Registration Number: 2183959

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## Sterilization Facility

Sterigenics US, Inc.
7775 S Quincy St.
Willowbrook, IL 60527

# Establishment Registration Number: 1450293

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.

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

Mr. Matthew D. Stepanek Senior Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K112842

Trade/Device Name: AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite 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: September 28, 2011 Received: September 29, 2011

Dear Mr. Stepanek:

This letter corrects our substantially equivalent letter of October 25, 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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K112842

with

Statement of Indications for Use

| Section 5 | Statement of Indications for |
|-----------|------------------------------|
|-----------|------------------------------|

| 510(k) Number: | K112842 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite AMS Elevate® PC Apical and Posterior Prolapse Repair System with |

Indications for Use:

IntePro® Lite

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Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112842

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