ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

K090713 · American Medical Systems, Inc. · OTP · Apr 2, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090713
• Device Name: ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
• Applicant: American Medical Systems, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Apr 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Indications for Use

The AMS Elevate Prolapse 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

Elevate Prolapse Repair System consists of permanently-implanted mesh assemblies and non-implanted surgical instruments; used to place mesh in pelvic floor. Modification adds synthetic phosphorylcholine (PC) polymer coating to center IntePro Lite section of mesh. Device used by surgeons in clinical settings for pelvic floor repair and soft tissue reinforcement. Output is physical support for weakened or ruptured tissue. Benefit is improved structural integrity of pelvic floor anatomy. Safety assessed via dFMECA; testing confirmed risks mitigated.

Clinical Evidence

No clinical data. Bench testing performed to assess impact of PC coating modification as part of dFMECA mitigation.

Technological Characteristics

Surgical mesh, polymeric. Consists of permanently-implanted mesh assembly with synthetic phosphorylcholine (PC) polymer coating on center IntePro Lite section. Includes non-implanted surgical instruments for mesh placement.

Indications for Use

Indicated for patients requiring reinforcement of soft tissues or repair of ruptured connective tissue in urological, gynecological, and gastroenterological anatomy, including pelvic floor reconstruction, vaginal wall prolapse repair, and pubourethral support.

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

• Elevate Prolapse Repair System with IntePro Lite

Submission Summary (Full Text)

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### APR - 2 2009

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| 2.6 | 510(k) Summary |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------|
| Submitter: | American Medical Systems<br>10700 Bren Road West<br>Minnetonka, MN 55343<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Denise Thompson |
| Date Summary Prepared: | March 17, 2009 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | Elevate Prolapse Repair System with PC<br>Coated IntePro Lite |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | Elevate Prolapse Repair System with IntePro Lite |

## Device Description

The Elevate System is part of the AMS Pelvic Floor Repair System family of devices. It consists of permanently-implanted mesh assemblies and non-implanted surgical instruments that are used as aids to place the mesh assembly in the pelvic floor.

### Indications for Use

The Elevate Prolapse 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.

### Comparison to Predicate Devices

The Elevate System is identical to the previous version with the exception of a synthetic phosphorylcholine (PC) polymer coating being added to the center IntePro Lite section of the mesh assembly.

### Supporting Information

A Design Failure Mode Effects and Criticality Analysis (dFMECA) was used to assess the impact of the modification. The performance parameters which were identified as potentially able to be affected by the modification were tested as mitigation. The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised.

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## 3. Labeling

- Draft Labeling and Instructions for Use for the Elevate System with PC coated . IntePro Lite are provided in Appendix A.
- A copy of the predicate Labeling and Instructions for Use for the Elevate System . with IntePro Lite are provided in Appendix B.

Special 510(k) - AMS Elevate with PC Coated ELPP

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

American Medical Systems % Ms. Denise Thompson Sr. Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K090713 Trade/Device Name: Elevate Prolapse Repair System with PC Coated IntePro Lite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 17, 2009 Received: March 18, 2009

Dear Ms. Thompson:

This letter corrects our substantially equivalent letter of April 2, 2009.

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.

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 STATEMENT

K090713 510(k) Number (if known):

Device Name: Elevate Prolapse Repair System with PC Coated IntePro Lite

Indications For Use:

The AMS Elevate Prolapse 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 (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) (Divisi: .. . gri-gii) Division of General, Restorative, Division of General, Restorative, and Neurological Devices and Neurological Devices

**510(k) Number:** K90115

Special 510(k) - AMS Elevate with PC Coal

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