WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM

K073266 · Boston Scientific Corp · ESW · Feb 27, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073266
• Device Name: WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Feb 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed device is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula

Device Story

Self-expanding Nitinol stent with partial silicone covering; delivery system uses coaxial tubing assembly to constrain stent until deployment. Used in clinical setting for maintaining esophageal luminal patency in patients with malignant strictures or fistulas. Stent diameters 18mm (23mm flare) and 23mm (28mm flare); lengths 103-155mm. Physician-operated; device provides mechanical support to esophageal wall to prevent occlusion. Benefits include restoration of luminal patency and management of fistula.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluation included dimensional analysis, radial expansion force, radial compression force, deployment and reconstrainment force, and bond integrity testing.

Technological Characteristics

Nitinol self-expanding stent with partial silicone covering. Coaxial tubing delivery system. Available in 18mm and 23mm body diameters with corresponding flares and multiple lengths. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors and for the occlusion of concurrent esophageal fistula.

Regulatory Classification

Identification

An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Ultraflex™ Covered Esophageal NG Stent System (K032930, K012883, K955347, K940838)
• Wallstent™ Esophageal II Stent (K940395)
• Polyflex™ Esophageal Stent System (K030559, K010068)
• Wallflex™ Enteral Colonic Stent System and Anchor Lock Delivery System (K042065)

Submission Summary (Full Text)

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X073266

page 1 of 2

FEB 2 7 2008

510(k) Summary

SECTION 5

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01760-1537

Contact: Neil Kelly Regulatory Affairs Specialist Date Prepared: October 30, 2007

#### 2. Device:

Trade Name: WallFlex™ Partially Covered Esophageal Stent System Common Name: Esophageal Stent Classification Name: Prosthesis, Esophageal Product Code: ESW Classification: Class II per 21 CFR 878.3610

## 3. Predicate Devices:

#### Stent:

Ultraflex™ Covered Esophageal NG Stent System (K032930, K012883, K955347, and K940838) Wallstent™ Esophageal II Stent (K940395) Polyflex™ Esophageal Stent System (K030559 and K010068)

## Delivery System:

Wallflex™ Enteral Colonic Stent System and Anchor Lock Delivery System (K042065)

## 4. Device Description:

The proposed WallFlex™ Partially Covered Esophageal Stent System consists of a selfexpanding metal stent and a delivery system. The proposed stent is manufactured of Nitinol and offered with a partial silicone covering. The stent configurations include two diameters, a 18mm body diameter with a 23mm flare, and a 23mm body diameter with a 28mm flare and three lengths. The 18mm body diameter stent is offered in 103mm, 123mm, and 153mm stent lengths. The 23mm body diameter stent is offered in 105mm, 125mm, and 155mm stent lengths. The proposed delivery system consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released.

> Premarket Notification, WallFlex Partially Covered Esophageal Stent System Proprietary and Confidential Information of Boston Scientific Corporation

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1072266 2 of 2

## 5. Intended Use:

The proposed device is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula

#### 6. Technological Characteristics:

The proposed WallFlex™ Partially Covered Esophageal Stent System has similar technological characteristics as the predicate devices. The proposed stent combines the design features of the Ultraflex™ Covered Esophageal NG stent, the Wallstent Esophageal II stent, and the Polyflex Esophageal Stent system. The proposed delivery system has similar technological characteristics to the predicate Wallflex Enteral Colonic Stent System with Anchor Lock Delivery System.

## 7. Performance Data:

Comparative performance testing was performed to establish substantial equivalence between the proposed WallFlex™ Partially Covered Esophageal Stent System, and the predicate devices. This testing included but was not limited to a dimensional evaluation, radial expansion force, radial compression force, deployment and reconstrainment force, and bond integrity.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed WallFlex™ Partially Covered Esophageal Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed stent systems: Ultraflex™ Covered Esophageal NG Stent, Wallstent Esophageal II Stent System, Polyflex Esophageal Stent System, and the Wallflex Enteral Colonic Stent System with Anchor Lock Delivery System.

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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 consists of a stylized eagle with three stripes representing human services, public health, and human potential. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.

FEB 2 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Neil Kelly Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy 100 Boston Scientific Wav MARLBOROUGH MA 01752-1234

Re: K073266

> Trade/Device Name: WallFlex™ Partially Covered Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: February 14, 2008 Received: February 19, 2008

Dear Mr. Kelly:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K073266

SECTION 4 Indications for Use Statement

K073266
510(k) Number (if known): To Be Determined

Device Name: WallFlex™ Partially Covered Esophageal Stent System

Indications For Use:

The proposed device is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula

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

Over-The-Counter Use (21 CFR 807 Subpart C)

000

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal,<br>and Radiological Devices | |
| 510(k) Number | K073266 |

Premarket Notification, WallFlex Partially Covered Esophageal Stent System Proprietary and Confidential Information of Boston Scientific Corporation