APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

K081710 · American Medical Systems · OTP · Oct 15, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081710
• Device Name: APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
• Applicant: American Medical Systems
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Traditional
• 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

Apogee and Perigee systems are pelvic floor repair devices consisting of a permanently implanted synthetic mesh assembly and non-implanted needle passer instruments. The mesh is used to reinforce soft tissues or repair ruptured connective tissue in urological, gynecological, and gastroenterological procedures. The device features a synthetic phosphorylcholine (PC) polymer coating on the center section of the mesh. The system is used by surgeons in a clinical setting to assist in pelvic floor reconstruction and prolapse repair. The mesh provides structural support to weakened anatomy, aiming to restore pelvic floor integrity and function.

Clinical Evidence

Bench testing only. No clinical data provided. Performance requirements were verified through comparative testing of mesh with and without the PC coating, including mechanical properties (tensile, cycle, elongation, stiffness) and physical dimensions (fiber diameter, pore size, density, thickness).

Technological Characteristics

Surgical mesh, polymeric (OTP). Features a synthetic phosphorylcholine (PC) polymer coating on the center section of the mesh assembly. Includes non-implanted needle passer instruments. Mechanical properties tested include tensile strength, cycle, elongation, and stiffness. Physical characteristics include fiber diameter, pore size, mesh density, and mesh thickness.

Indications for Use

Indicated for patients requiring reinforcement of soft tissues or repair of ruptured connective tissue in urological, gynecological, and gastroenterological anatomy, including pubourethral support, urethral slings, 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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K081710

# PCT 1 5 2008

#### న. 510(k) Summary

| Submitter: | American Medical Systems (AMS)<br>10070 Bren Road West<br>Minnetonka, MN 55343<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Denise Thompson |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | Apogee® and Perigee® Systems with<br>PC Coated IntePro® Lite |
| Device Classification Name: | Surgical Mesh, polymeric (OTP) |
| Predicate Devices: | AMS Pelvic Floor Repair System (K051485) |

#### Device Description

The Apogee and Perigee prolapse repair systems are part of the AMS Pelvic Floor Repair System family of devices. They consist of a permanently-implanted mesh assembly and non-implanted surgical instruments (needle passers) that are used as aids to place the mesh assembly in the pelvic floor.

## 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.

## Comparison to Predicate Devices

The Apogee and Perigee System are identical to the previous with the exception of a synthetic phosphorylcholine (PC) polymer coating being added to the center section of the mesh assembly.

#### Supporting Information

The components of the Apogee and Perigee systems have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device. A comparison of the mesh with and without the PC coating was made. Tensile, cycle, elongation and stiffness testing were performed in both the weft and warp directions of the mesh. In addition, a comparison of the dimensional characteristics was completed and included fiber diameter, pore size, mesh density and mesh thickness.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human profiles facing right.

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

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

SEP 2 8 2012

K081710 Re: Trade/Device Name: Apogee® System with PC Coated IntelPro® Lite™ Perigree® System with PC Coated IntelPro® Lite™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: October 3, 2008 Received: October 6, 2008

Dear Ms. Thompson:

This letter corrects our substantially equivalent letter of October 15, 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 (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/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. Weeks

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):

Device Name: Apogee® System with PC Coated IntePro® Lite™ Perigee® System with PC Coated IntePro® Lite™

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 tissucs 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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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(Division Sion. General. Restorative. Division and Neurologica! Beri

510(k) Number

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