WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

K993232 · Boston Scientific Scimed, Inc. · FGE · Dec 30, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993232
• Device Name: WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Dec 30, 1999
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wallstent® Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

Device Story

Self-expanding biliary stent; constructed of biomedical superalloy and elastomeric polymer; braided wire structure; optional elastomeric covering. Used to maintain or increase inner lumen diameter of biliary duct in patients with malignant biliary strictures. Delivered via coaxial tubing assembly (Unistep™ Plus Delivery System); stent constrained by outer sheath; release achieved by sheath retraction. Intended for single use; sterile. Physician-operated in clinical setting. Reduced profile (smaller French size) compared to predicate. Stent provides outward radial force for stabilization. Safety/effectiveness for vascular use not established.

Clinical Evidence

Bench testing only; in vitro testing performed to compare deployment forces and handling characteristics of the reduced-profile delivery system against the predicate.

Technological Characteristics

Self-expanding braided wire stent; materials: biomedical superalloy, elastomeric polymer; radiopaque core in smaller models. Delivery system: coaxial tubing assembly. Reduced profile (smaller French size) compared to predicate. Sterile, single-use.

Indications for Use

Indicated for the palliation of malignant neoplasms in the biliary tree.

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® Biliary Endoprosthesis with Unistep™ Plus Delivery System (K964119)

Submission Summary (Full Text)

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| | | K993232 |
|--------------------------------|----------------|------------------------------------------------------------------------------------------------------------------|
| DEC 30 1999 | | Premarket Notification for the WALLSTENT® Biliary Endoprosthesis<br>With Unistep™ Plus Delivery System<br>1 of 2 |
| 16. 510(k) Summary | | |
| Date Prepared | | September 24, 1999 |
| Submitter | Address: | Boston Scientific Corporation<br>Plymouth Technology Center<br>5905 Nathan Lane<br>Minneapolis, MN 55442 |
| | Phone:<br>Fax: | [phone]<br>[phone] |
| Contact Person | | Ronald W. Bennett<br>Regulatory Affairs Project Manager |
| Device Name and Classification | | |
| | Trade Name | WALLSTENT® Biliary Endoprosthesis<br>with Unistep™ Plus Delivery System |
| | Common Name | Biliary Stent |
| | Classification | Class II |
| Predicate Devices | | WALLSTENT® Biliary Endoprosthesis |

## Device Description

The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure that may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumen diameter of the biliary duct.

with Unistep™ Plus Delivery System - K964119

The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

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## Indication

The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.

### Technological Characteristics

The purpose of this 510(k) is to allow an alternate delivery system. Compared to the present Unistep™ Plus Delivery System (K964119), this version of the Unistep™ Plus delivery system has a reduced profile, that is smaller French size.

The alternate delivery system can be found substantially equivalent based on the results of in vitro testing that demonstrates the deployment forces and handling characteristics are comparable to the current delivery systems.

#### Summary

In summary Boston Scientific Corporation has demonstrated that the WALLSTENT® Biliary Endoprosthesis with Unistep™ Plus Delivery with reduced profile for the delivery system is substantially equivalent based on design, test results, and indications for use to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a bird in flight, with three wavy lines representing the bird's wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 1999

Mr. Ronald W. Bennett Regulatory Affairs Project Manager Plymouth Technology Center Boston Scientific Corporation 5905 Nathan Lane Plymouth, MN 55442

Re: K993232 Wallstent® Biliary Endoprosthesis Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: September 24, 1999 Received: September 27, 1999

Dear Mr. Bennett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 - Mr. Ronald W. Bennett

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Cover Cood Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with he GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Lumber C. Richter for

David W. Feigal, Jr., M.D., M.P.H. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ l of 1

510(k) Number (if known): K993232

Device Name: Wallstent® Biliary Endoprosthesis________________________________________________________________________________________________________________________________

FDA's Statement of the Indications For Use for device:

The Wallstent® Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

(Division of Recording Abdominal, ENT, Division ( ... .. .. .. .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...

510(k) Number --

Prescription Use_L/ OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________