MODIFICATION TO SURGICAL MESH POLYMERIC

K040787 · Boston Scientific · OTN · Apr 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040787
• Device Name: MODIFICATION TO SURGICAL MESH POLYMERIC
• Applicant: Boston Scientific
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Special
• 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

Obtryx™ System (Halo or Curved) and Prefyx PPS™ System are sterile, single-use surgical mesh implants for suburethral sling procedures. Device consists of knitted polypropylene monofilament fiber mesh body, dilators with association loops, mesh sleeve, and center tab. Used with delivery devices featuring polymer handles and stainless steel needles to place implant. Operated by surgeons in clinical/surgical settings. Mesh provides mechanical support to urethra to treat stress urinary incontinence. Benefit is restoration of continence in patients with urethral hypermobility or intrinsic sphincter deficiency.

Clinical Evidence

No clinical data. Substantial equivalence based on identical materials, design, and intended use to predicate devices; bench testing and biocompatibility data previously established.

Technological Characteristics

Knitted polypropylene monofilament fiber mesh. Delivery system includes polymer handle and stainless steel needle. Sterile, single-use. No software or electronic components.

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™, Advantage Fit™ System & Lynx™ Systems (K020110)

Submission Summary (Full Text)

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Boston Scientific Corporation

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

#### A. Sponsor

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

#### B. Contact

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

#### C. Device Name

Tradename: Obtryx™ System (Halo or Curved) and Prefyx PPSTM System Common/usual name: Surgical Mesh Classification Name: OTN - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II

#### D. Predicate Device(s)

| Tradename: | AdvantageTM, Advantage FitTM System & LynxTM<br>Systems |
|-------------------------|-------------------------------------------------------------|
| Common/usual name: | Surgical Mesh |
| Classification Name: | OTN- Mesh, Surgical, Polymeric<br>21 CFR 878.3300, Class II |
| Premarket Notification: | Boston Scientific Corporation,<br>K020110 |

#### E. Device Description

The proposed sling 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 implant, dilators with association loops, mesh sleeve and center tab.

Addition of documentation for Special 510(k) K040787 Surgical Mesh April 11, 2013

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#### Accessories

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

Two (2) delivery devices (Halo or Curved) are used in conjunction with the mesh assembly to place the mesh implant. Each of the delivery devices consist of a polymer handle and a stainless steel needle which extends from the handle. The tip of the needle has a slot which is used to attach the association loop of the mesh assembly

#### 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 intended use and the materials of the surgical mesh are identical to the predicate device.

#### 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 sling is substantially equivalent to the predicate sling in terms of intended use, technological characteristics, and performance characteristics tested. The proposed sling is as safe, as effective, and performs as well as the predicate devices.

#### 1. Non-Clinicial Testing

The surgical mesh is identical to currently marketed surgical mesh in terms of performance characteristics, biocompatibility, and intended use. Therefore, testing was not required to be repeated on the surgical mesh.

#### Conclusion:

Based on testing results of the material, biocompatiblity, bench testing, and the proposed device labeling, the device is substantially equivalent to the identified predicate device in terms of intended use, previously classified under 21 CFR 878.3300 as Class II, mesh surgical, polymeric, in terms of intended use and thefore do not adversely effect safety and effectiveness.

Addition of documentation for Special 510(k) K040787 Surgical Mesh April 11, 2013

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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 features a stylized symbol resembling a bird or a wing-like shape, composed of curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

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

September 13, 2013

Boston Scientific Corporation Urology and Gynecology Division % Janet A. McGrath Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760

Re: K040787

Trade/Device Name: Obtryx™ System (Halo or Curved) and Prefyx PPSTM System Regulation Number: 21 CFR\$ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): March 24, 2004 Received (Date on orig SE ltr): April 1, 2004

Dear Janet A. McGrath,

This letter corrects our substantially equivalent letter of April 14, 2004.

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Janet A. McGrath

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

# Herbert P. Lerner -S

for

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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Boston Scientific Corporation

CONFIDENTIAL

## Indications for Use Statement

510(k) Number (if Known): K040787

Device Name: Obtryx™ System (Halo or Curved) and Prefyx PPSTM System

#### 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 __ X (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)

# Herbe