PINNACLE PELVIC FLOOR REPAIR KITS

K071957 · Boston Scientific Corp · OTP · Nov 8, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K071957
• Device Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Applicant: Boston Scientific Corp
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Nov 8, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Pinnacle Thi Pelvic Floor Repair Kits are 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.

Device Story

Pinnacle Pelvic Floor Repair Kits are sterile, single-use surgical mesh assemblies designed for pelvic floor reconstruction. The device consists of a polypropylene knitted mesh body with integrated legs protected by disposable polymer sleeves. A lead with a needle at the distal end of the sleeve facilitates passage through bodily tissues for placement, intended for use with the Capio Open Access Suture Capturing Device. Available in three models (Total, Anterior/Apical, and Posterior) to address specific vaginal wall defects. Used by surgeons in clinical settings to provide mechanical support or bridge fascial defects during vaginal repair procedures, potentially improving patient outcomes by stabilizing pelvic floor structures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Polypropylene knitted mesh; sterile, single-use; includes disposable polymer sleeves and needle-based delivery system for use with Capio Suture Capturing Device. Available in Total, Anterior/Apical, and Posterior configurations.

Indications for Use

Indicated for tissue reinforcement and stabilization of pelvic floor fascial structures in patients with vaginal wall prolapse requiring surgical treatment, serving as mechanical support or bridging material for fascial defects.

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

• Polyform Synthetic Mesh (K051245)

Reference Devices

• Capio Open Access Suture Capturing Device

Submission Summary (Full Text)

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## 510(k) Summary for the Pinnacle™ Pelvic Floor Repair Mesh

#### A. Sponsor

Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01756

#### B. Contact

NOV U 8 2007

Michelle M. Berry Senior, Regulatory Affairs Specialist 508-683-4941

Or

Donna Gardner Director, Regulatory Affairs 508-683-4398

### C. Device Name

| Tradename: | Pinnacle™ Pelvic Floor Repair Kits |
|----------------------|------------------------------------|
| Common/usual name: | Surgical Mesh |
| Classification Name: | FTL – Mesh, Surgical, Polymeric |
| | 21 CFR 878.3300, Class II |

#### D. Predicate Device(s)

| Tradename: | Polyform Synthetic Mesh |
|-------------------------|---------------------------------|
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTP- Mesh, Surgical, Polymeric |
| | 21 CFR 878.3300, Class II |
| Premarket Notification: | Proxy Biomedical, Ltd., K051245 |

#### 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. The proposed mesh will be offered in three mesh models: Total, Anterior/Apical and Posterior designed for performing total vaginal repair, anterior vaginal defects and posterior and/or apical vaginal vault defects respectively.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

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

SEP 2 8 2012

Re: K071957 Trade/Device Name: Undetermined Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: October 3, 2007 Received: October 4, 2007

Dear Ms. Berry:

This letter corrects our substantially equivalent letter of November 8, 2007.

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 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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Indications for Use Statement

# 510(k) Number (if Known): KOZI957

Device Name: Undetermined

#### Indications For Use:

The Pinnacle Thi Pelvic Floor Repair Kits are 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 a Evaluation (ODE)

> (Division Division of General, Restorative, and Neurological Devices

**510(k) Number** 1671987

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