WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730

K091510 · Boston Scientific Corporation · ESW · Jun 26, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091510
• Device Name: WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
• Applicant: Boston Scientific Corporation
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Jun 26, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by instrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

Device Story

Self-expanding metal stent system for esophageal use; consists of metallic radiopaque cylindrical mesh stent fully covered with silicone polymer; includes coaxial delivery system with clear exterior tube for stent constraint/reconstraint and interior tube for 0.038" guidewire; includes proximal suture for removal during initial placement. Used by physicians in clinical settings to maintain luminal patency in malignant strictures and occlude fistulae; provides mechanical support to esophageal wall; benefits patient by restoring esophageal function and managing fistula-related complications.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Metallic radiopaque cylindrical mesh stent; silicone polymer full covering; coaxial delivery system; 0.038" guidewire compatible; self-expanding mechanism.

Indications for Use

Indicated for maintaining esophageal luminal patency in patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and for 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

• WallFlex Esophageal Partially Covered Stent System (K073266)
• ALIMAXX-E Esophageal Stent System (K051621, K080838)

Submission Summary (Full Text)

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# 011510 1 of 2

# SECTION 5 510(k) SUMMARY

#### 510(k) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Marybeth Gamber Manager, Regulatory Affairs Date Prepared: May 21, 2009

#### 2. Device:

Trade Name: WallFlex Esophageal Fully Covered Stent System Classification Name: Prosthesis, Esophageal Regulation Number: 21 CFR 878.3610 Product Code: ESW Classification: Class II

#### 3. Predicate Device:

WallFlex Esophageal Partially Covered Stent System K073266 Manufactured by Boston Scientific, Inc.

K051621, K080838

ALIMAXX-E Esophageal Stent System Manufactured by Alveolus, Inc

#### 4. Device Description:

The proposed WallFlex Esophageal Fully Covered Stent System consists of a selfexpanding metal stent and a delivery system. The proposed stent is manufactured from a metallic radiopaque material that is formed into a cylindrical mesh. It is fully covered with a silicone polymer. A suture is threaded through the proximal end of the stent and is intended to aid in removal during the initial stent placement procedure, to be used in the event of incorrect placement. The delivery system is a coaxial tube design. The exterior tube is used to constrain the stent before deployment and reconstrain the stent, if desired, after partial deployment. The exterior tube has a clear section so that the contrained stent is visible. The interior tube has a single central lumen to accommodate a 0.038" guidewire.

#### 5. Intended Use:

The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by instrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

## 6. Technological Characteristics:

The proposed WallFlex Esophageal Fully Covered Stent System is similar in design. materials, and manufacturing processes to the predicate devices, the WallFlex Esophageal

JUN 26 2009

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K091570
pg 2 of 2

Partially Covered Stent System (K073266) and the ALIMAXX-E Esophageal Stent System (K051621, K080838).

### 7. Performance Data:

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed WallFlex Esophageal Fully Covered Stent System is substantially equivalent to the currently marketed WallFlex Esophageal Partially Covered Stent System (K073266) and the ALIMAXX-E Esophageal Stent System (K051621, K080838).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes, oriented diagonally.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 2009

Ms. Marybeth Gamber Manager II, Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way Endoscopy Division, M11 MARLBOROUGH MA 01752

Re: K091510

Trade/Device Name: WallFlex Esophageal Fully Covered Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: May 21, 2009 Received: May 27, 2009

Dear Ms. Gamber:

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 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 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/CDRHOffices/ucm115809.html 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Indications for Use:

This application

WallFlex Esophageal Fully Covered Stent System

The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

091510

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

until (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

510(k) Number