APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM

K082387 · American Medical Systems · OTP · Dec 4, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082387
• Device Name: APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
• Applicant: American Medical Systems
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Dec 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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 for the treatment of incontinence, 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 sterile, single-use procedure kits for pelvic floor repair. Kits include stainless steel curved needle passers and implantable mesh assembly (IntePro Lite or InteXen LP). Used by surgeons in clinical settings to reinforce weakened or ruptured connective tissue. Mesh provides structural support for pelvic organs; needle passers facilitate precise placement during surgical procedures. Output is physical reinforcement of anatomical structures; aids in treating incontinence and prolapse. Benefits include restored pelvic floor integrity and improved patient outcomes.

Clinical Evidence

Bench testing only; no clinical data provided. Biocompatibility and performance requirements were met.

Technological Characteristics

Sterile, single-use kit. Components: stainless steel curved needle passers and polymeric surgical mesh (IntePro Lite or InteXen LP). Class II, 21 CFR 878.3300. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring connective tissue repair or soft tissue reinforcement in urological, gynecological, and gastroenterological anatomy, including treatment for incontinence, vaginal wall prolapse, 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

• Apogee and Perigee Systems with IntePro Lite and InteXen LP (K051485)

Submission Summary (Full Text)

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# DEC 0 4 2008

## 510(k) Summary Statement

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

### Indications for Use

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

#### Device Description

The Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.

#### Summary of Testing

The components of the Apogee and Perigee Systems with IntePro Lite and InteXen LP have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices.

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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 eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

American Medical Systems (AMS) %. Ms. Sarah Peterson 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K082387

Trade/Device Name: Apogee and Perigee Systems with IntePro Life and InteXen LP, Part of the AMS Pelvic Floor Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: November 3, 2008 Received: November 4, 2008

Dear Ms. Anderson:

This letter corrects our substantially equivalent letter of December 4, 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/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

| 510(k) Number: (If known) | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Apogee and Perigee Systems with IntePro Lite and InteXen LP, Part of the AMS Pelvic Floor Repair System |
| Indications For Use: | 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 for the treatment of incontinence, 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nitho Dyln for man

08238

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

**510(k) Number**

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K082387