BOSTON SCIENTIFIC SURGICAL MESH

K081275 · Boston Scientific Corp · PAH · Aug 27, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081275
• Device Name: BOSTON SCIENTIFIC SURGICAL MESH
• Applicant: Boston Scientific Corp
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Aug 27, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

Sterile, single-use synthetic mesh sling assembly; consists of knitted polypropylene monofilament fiber mesh body with polypropylene carriers at ends. Packaged with delivery device. Used by surgeons in clinical settings for suburethral sling placement to treat stress urinary incontinence. Device provides mechanical support to urethra to restore continence.

Clinical Evidence

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

Technological Characteristics

Knitted polypropylene monofilament fiber mesh with polypropylene carriers. Sterile, single-use. Class II device (21 CFR 878.3300).

Indications for Use

Indicated for patients with stress urinary incontinence caused by urethral hypermobility and/or intrinsic sphincter deficiency.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Advantage Transvaginal Mid Urethral Sling System (K020110)
• Advantage Fit System (K020110)
• Lynx Suprapubic Mid Urethral Sling System (K040787)
• Obtryx Transobturator Mid Urethral Sling System (K040787)
• Prefyx PPS System (K073703)
• AMS MiniArc Sling System (K073703)

Submission Summary (Full Text)

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K081275
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#### 510(k) Summary for Surgical Mesh

#### A. Sponsor

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

#### B. Contact

Janet A. McGrath Principal Regulatory Affairs Specialist 508-683-4726 or Donna Gardner Director, Regulatory Affairs 508-683-4398

## C. Device Name

Tradename: Surgical Mesh, (SIS) Common/usual name: Surgical Mesh Classification Namer 7447 - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II

# D. Predicate Device(s)

Tradename:

Advantage® Transvaginal Mid Urethral Sling System Advantage Fit™ System Lynx ® Suprapubic Mid Urethral Sling System Obtryx® Transobturator Mid Urethral Sling System Prefyx PPS® System AMS MiniArcTM Sling System

Common/usual name: Surgical Mesh Classification Name: (PAH) - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II

#### Premarket

Notification: Boston Scientific Corporation: K020110. K040787 American Medical System.Inc .: K073703

### E. Device Description

The proposed device is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body with polypropylene carriers, each are attached to separate ends.

# Accessories

The proposed mesh sling configuration is packaged with other legally marketed accessories (e.g., Delivery Device; Class I exempt: 876.4730 Manual gastroenterology-urology surgical instrument and accessories).

AUG 2.7 2008

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K081275
kg 2022

# F. Intended Use

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

# G. Technological Characteristics

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

# 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right, and its head is slightly tilted upwards. 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. Janet A. McGrath Principal Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752

SEP 2 8 2012

K081275 Re: Trade/Device Name: Surgical Mesh, (SIS) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: August 13, 2008 Received: August 14, 2008

Dear Ms. McGrath:

This letter corrects our substantially equivalent letter of August 27, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Runkle

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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K081275

### Indications for Use Statement

510(k) Number (if Known): K081275

Device Name: Surgical Mesh , (SIS)

Indications For Use:

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Prescription Use ਮ (21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number