PINNACLE PELVIC FLOOR REPAIR KIT II

K081048 · Boston Scientific Corp · OTP · Aug 22, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081048
• Device Name: PINNACLE PELVIC FLOOR REPAIR KIT II
• Applicant: Boston Scientific Corp
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The proposed device is intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Story

Sterile, single-use surgical mesh assembly for pelvic floor repair. Composed of polypropylene knitted mesh with integrated legs protected by disposable polymer sleeves. Distal end of sleeve features a lead with needle for use with Capio™ Open Access Suture Capturing Device. Facilitates passage of mesh through bodily tissues for placement as mechanical support or bridging material for fascial defects. Used by surgeons in clinical/surgical settings to treat vaginal wall prolapse. Provides structural reinforcement to pelvic floor fascial structures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance testing.

Technological Characteristics

Polypropylene knitted mesh assembly with integrated legs and disposable polymer sleeves. Includes a lead with needle for suture capturing. Sterile, single-use device.

Indications for Use

Indicated for patients requiring surgical treatment for vaginal wall prolapse, specifically for tissue reinforcement and stabilization of pelvic floor fascial structures.

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

• Pinnacle Pelvic Floor Repair Kit (K071957)
• Prolift Pelvic Floor Repair Systems (K071512)

Submission Summary (Full Text)

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### 510(k) Summary

#### A. Sponsor

Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01752

# B. Contact

Michelle Berry Senior, Regulatory Affairs Specialist 508-683-4941 or Donna Gardner Director, Regulatory Affairs 508-683-4398

### C. Device Name

Tradename: TBD Common/usual name: Surgical Mesh Classification Name: ON. - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II

#### D. Predicate Device(s)

| Tradename: | Pinnacle Pelvic Floor Repair Kit |
|-------------------------|-------------------------------------------------------------|
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTP- Mesh, Surgical, Polymeric<br>21 CFR 878.3300, Class II |
| Premarket Notification: | Boston Scientific, K071957<br>and |
| Tradename: | Prolift Pelvic Floor Repair Systems |
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTP-Mesh, Surgical, Polymeric<br>21 CFR 878.3300, Class II |
| Premarket Notification: | Gynecare, K071512 |

### E. Device Description

The proposed device is a sterile, single use device, consisting of a synthetic mesh assembly and needle holder. The mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the currently legally marketed Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

AUG 2 2 2008

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K081048

pg 2.4)2-

# F. Intended Use

The proposed device is intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

# G. Technological Characteristics

The proposed device has the same technological characteristics (i.e. mesh design and mesh material) as the predicate.

#### H. Substantial Equivalence

Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" and "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", a direct comparison of key characteristics demonstrates that the proposed mesh is substantially equivalent to the predicate mesh in terms of intended use, technological characteristics, and performance characteristics tested. The proposed device is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.

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

Ms. Michelle Berry Senior Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752

SEP 2 8 2012

Re: K081048 Trade/Device Name: Modified Pinnacle Pelvic Floor Repair Kit - Apical Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: August 13, 2008 Received: August 14, 2008

Dear Ms. Berry:

This letter corrects our substantially equivalent letter of August 22, 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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K081048

### Indications for Use Statement

510(k) Number (if Known):

Device Name: Pinnacle™ Pelvic Floor Repair Kit - Apical

Indications For Use:

The proposed Pinnacle Pelvic Floor Repair Kit is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Prescription Use X (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

Mark A Mikkelsen

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

**510(k) Number**