WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030

K062750 · Boston Scientific Corp · MUM · Dec 4, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062750
• Device Name: WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
• Applicant: Boston Scientific Corp
• Product Code: MUM · General, Plastic Surgery
• Decision Date: Dec 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed WallFlex™ Enteral Duodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

Device Story

WallFlex Enteral Duodenal Stent System consists of implantable Nitinol stent and coaxial Anchor Lock Delivery System. Stent features 22mm body diameter, 27mm distal flare, and lengths of 6cm, 9cm, or 12cm. Delivery system constrains stent until deployment via retraction of exterior tube. Used by clinicians for palliative treatment of malignant gastroduodenal obstructions. Stent provides mechanical patency to relieve obstruction, improving patient quality of life.

Clinical Evidence

Clinical data included in support of the proposed indication for the WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System.

Technological Characteristics

Nitinol stent; 22mm body diameter; 27mm distal flare; 6cm, 9cm, 12cm lengths. Coaxial tubing assembly delivery system. Mechanical expansion principle. No software or electronic components.

Indications for Use

Indicated for palliative treatment of gastroduodenal obstructions caused by malignant neoplasms in patients requiring stent placement.

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™ Enteral Colonic Stent System with Anchor Lock Delivery System (K042065)
• Wallstent Enteral Endoprosthesis (K000281)

Submission Summary (Full Text)

{0}------------------------------------------------

# UEL - 4 2006

## 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: Allyson Barford, RAC Regulatory Affairs Specialist Date Prepared: September 13, 2006

#### 2. Device:

Trade Name: WallFlex™ Enteral Duodenal Stent System with Anchor Lock Delivery System Common Name: Esophageal prosthesis Classification Name: Expandable, metallic duodenal stent Regulation Number: 878.3610 Product Code: MUM Classification: Class II

#### 3. Predicate Device:

WallFlex™ Enteral Colonic Stent System with Anchor Lock Delivery System, K042065 Wallstent Enteral Endoprosthesis, K000281 The predicate devices are class II devices per 21 CFR 878.3610

#### 4. Device Description:

The proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and has a 22mm body diameter with a 27mm distal flare diameter, and is offered in three lengths, 6cm, 9cm, and 12cm. The Anchor Lock Delivery System consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

#### 5. Intended Use:

The proposed WallFlex™ Enteral Duodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

{1}------------------------------------------------

### 6. Technological Characteristics:

The proposed WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System has the identical technological (materials, construction, processing) characteristics as the predicate WallFlex Enteral Colonic Stent with Anchor Lock Delivery System and has the identical indication statement as the predicate Wallstent Enteral Endoprosthesis.

### 7. Performance Data:

Clinical data in support of the proposed indication for the WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System has been included in this premarket notification.

### 8. Conclusion:

Boston Scientific Corporation has demonstrated that proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is substantially equivalent to the currently marketed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and in terms of the proposed indication to Boston Scientific's Wallstent Enteral Endoprosthesis.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wing, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC - 4 2006

Ms. Allyson Barford Regulatory Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752

Re: K062750

> Trade/Device Name: WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MUM Dated: September 13, 2006 Received: September 14, 2006

Dear Ms. Barford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rotened 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 ass stated in the enerobare) to regarly than of the Medical Device Amendments, or to devices that prov to May 20, 1976, the onabilities and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, Act (free) market the device, subject to the general controls provisions of the Act. The general therefore, manor the act include requirements for annual registration, listing of devices, good controls provisions or colors, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your device is oldsmired (000 as 11) diffinial controls. Existing major regulations affecting your Applovar, it may be saylor to outs Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" inside a circular border. The logo features the letters "FDA" in a stylized font above the word "Centennial". There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

{3}------------------------------------------------

Page 2 --

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.litml.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

{4}------------------------------------------------

# SECTION 4 INDICATIONS FOR USE STATEMENT

Indications for Use:

510(k) Number (if known): To Be Determined - KO 6 2750

K062750

Device Name: WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System

Indications For Use:

The WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

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)

Premarket Notification, WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System Proprietary and Confidential Information of Boston Scientific Corporation

00009

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------