BLUE SUI SLING

K121754 · Boston Scientific Corp · OTN · Oct 10, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121754
• Device Name: BLUE SUI SLING
• Applicant: Boston Scientific Corp
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Oct 10, 2012
• Decision: SESE
• Submission Type: Traditional
• 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 hypermobility and/or intrinsic sphincter deficiency.

Device Story

Obtryx II System is a sterile, single-use suburethral sling assembly used for treating female stress urinary incontinence. The device consists of a blue knitted polypropylene monofilament mesh implant and two delivery devices (Halo or Curved). The delivery device features a polymer handle and a stainless steel needle with a slotted tip for attaching the mesh association loop. During surgery, the physician uses the delivery device to place the mesh implant suburethrally. The mesh provides support to the urethra to address incontinence resulting from hypermobility or intrinsic sphincter deficiency. The device is intended for clinical use by physicians.

Clinical Evidence

No clinical data. Evidence consists of bench testing to verify performance specifications and biocompatibility testing conducted in accordance with EN ISO 10993-1.

Technological Characteristics

Synthetic mesh implant made of blue knitted polypropylene monofilament fiber. Includes association loops, dilator legs, sleeves, leader loops, center tab, and lead. Delivery system includes polymer handle and stainless steel needle. Biocompatibility tested per EN ISO 10993-1. Sterile, single-use.

Indications for Use

Indicated for female patients with stress urinary incontinence caused by 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 & Lynx Systems (K020110)
• Obtryx, Prefyx Systems (K040787)

Submission Summary (Full Text)

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K121754
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# 510(k) Summary for Blue SUI Sling

#### A. Sponsor

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

### 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

Obtryx II System Tradename: Common/usual name: Surgical Mesh Classification Name: OTN - Mesh, Surgical, Synthetic, Urogynecologic, for Stress Urinary Incontinence, Female, Multi-Incision 21 CFR 878.3300, Class II

#### D. Predicate Device(s)

| Tradename: | Advantage , Advantage Fit & Lynx Systems<br>Obtryx, Prefyx Systems |
|-------------------------|--------------------------------------------------------------------|
| Common/usual name: | Surgical Mesh |
| Classification Name: | FTL- Mesh, Surgical, Polymeric<br>21 CFR 878.3300, Class II |
| Premarket Notification: | Boston Scientific Corporation,<br>■ K020110<br>■ K040787 |

## 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 blue knitted polypropylene monofilament fiber mesh body implant, association loops, dilator legs, sleeves, leader loops, center tab and lead.

Traditional 510(k) Obtryx II System

OCT 10 2012

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K121754
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The proposed sling is packaged with (2) delivery devices (Halo or Curved) which 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 hypermobility and/or intrinsic sphincter deficiency.

## G. Technological Characteristics

The proposed sling has the same and/or equivalent technological characteristics (i.e. mesh design and mesh material) as the predicates K020110 & K040787.

## 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.

## I . Non-Clinicial Testing

Material testing was performed to demostrate that the material properites are suitable for the intended use.

Bench testing was performed to demostrate that the device as manufactured meets performance specifications. Test results demostrate that the device meets the predetermine specifications and is acceptable for clinical use.

Biocompatiblity testing was performed in accordance to standard EN ISO 10993-1 for each of the patient contacting materials, and results demonstrate that the device is biocompatible for its intended use.

## Conclusion:

Based on material, biocompatiblity, bench testing, and the proposed device labeling, the Obtryx II System is substantially equivalent to the identified predicate devices in terms of intended, use , safety and effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

#### Public Health Service

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

OCT 10 2012

Ms. Janet A. McGrath Principal Specialist Global Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way, M21 MARLBOROUGH MA 01752

Re: K121754

Trade/Device Name: Obtryx II System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: September 19, 2012 Received: September 20, 2012

#### Dear Ms. McGrath:

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.

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

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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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin K. Evanko

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

# Indications for Use Statement

510(k) Number (if Known): _KlZ|75L

Device Name: Obtryx II System

Indications For Use:

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

09 Oct 2012

oductive, Gastro-Renal, and

Traditional 510(k) Obtryx II System