WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540

K083627 · Boston Scientific Corporation · FGE · Apr 7, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083627
• Device Name: WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
• Applicant: Boston Scientific Corporation
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Apr 7, 2009
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Device Story

Self-expanding metal stent with Permalume coating; includes proximal retrieval loop for removal during initial placement. Stent mounted on coaxial sheath delivery system; delivery system constrains stent until release via retraction of exterior tube. Used in clinical settings by physicians for biliary stricture management. Device provides mechanical patency to obstructed bile ducts, facilitating palliative care for malignant neoplasms. Safety/effectiveness for vascular use not established.

Clinical Evidence

In-vitro, in-vivo, and clinical testing performed. All components and subassemblies met required specifications. No specific clinical metrics (e.g., patency rates, adverse event counts) provided in summary.

Technological Characteristics

Self-expanding metal stent; Permalume coating; coaxial sheath delivery system. Mechanical expansion mechanism. No software or electronic components.

Indications for Use

Indicated for palliative treatment of biliary strictures caused by malignant neoplasms in patients requiring biliary stenting.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• WallStent™ RX Biliary Endoprosthesis (K012752, K030107)
• WallFlex® Biliary RX Stent System (K061231)

Submission Summary (Full Text)

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KOB3627 g10f2

SECTION 5 510(k) SUMMARY

#### 510(k) SUMMARY

### 1. Submitter:

APR - 7 2009

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01760 Telephone: [phone] Fax: [phone]

Contact: Marybeth Gamber Manager, Regulatory Affairs Date Prepared: December 5, 2008

# 2. Device:

Trade Name: WallFlex® Biliary RX Fully Covered Stent System Common Name: Biliary Stent Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II

### 3. Predicate Device:

WallStent™ RX Biliary Endoprosthesis Manufactured by Boston Scientific. Inc. WallFlex® Biliary RX Stent System Manufactured by Boston Scientific, Inc. · K012752, K030107

K061231

#### 4. Device Description:

The WallFlex Biliary RX Fully Covered Stent System consists of a self-expanding metal stent and a delivery system. The stent is fully covered with Permalume coating and includes a retrieval loop at the proximal end of the stent to aid in removal during the initial stent placement procedure. The stent is mounted onto a sheath delivery system. The delivery system is a coaxial tubing assembly that constrains the stent onto the delivery system shaft until the stent is released by retracting the exterior tube.

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### 5. Intended Use:

The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

### 6. Technological Characteristics:

The WallFlex Biliary RX Fully Covered Stent System has the same technological characteristics as the currently marketed WallFlex Biliary RX Uncovered Stent System (K061231) and the Wallstent™ RX Biliary Endoprosthesis (K012752, K030107).

## 7. Performance Data:

In-vitro, in-vivo, and clinical testing have 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 Biliary RX Fully Covered Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed WallFlex Biliary RX Stent System (K061231) and Wallstent RX Biliary Endoprosthesis (K012752, K030107).

ર્ટર્

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written along the border of the seal. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR - 7 2009

Re: K083627

Trade/Device Name: WallFlex® Biliary RX Fully Covered Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 16, 2009 Received: March 31, 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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## Page 2 - Ms. Marybeth Gamber

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.html.

Sincerely yours,

Voetman

Donna-Bea Tillman, Ph.D., M.P.A. Director 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):

This application K083627

WallFlex® Biliary RX Fully Covered Stent System

Indications for Use:

Device Name:

The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

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

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

చెప్ప

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

QSTN

(DNision Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 68362 510(k) Number,

Premarket Notification, WallFiex® Biliary RX Fully Covered Stent System