ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM

K982346 · AngioDynamics, Inc. · FGE · Jan 29, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K982346
• Device Name: ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
• Applicant: AngioDynamics, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jan 29, 1999
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANGIODYNAMICS ANGIOSTENT Biliary Stent System is indicated for palliative treatment of malignant strictures in the biliary tree.

Device Story

AngioDynamics AngioStent Biliary Stent System; metallic stent for palliative treatment of malignant biliary strictures. Device deployed in biliary ducts to maintain patency; relieves obstructions caused by malignancy. Used by clinicians in clinical settings. Output is mechanical support of ductal structure; improves patient quality of life by facilitating bile flow. Safety/effectiveness for vascular use not established; labeling must explicitly state biliary use.

Technological Characteristics

Metallic biliary stent; intended for ductal placement. Class II device (21 CFR 876.5010).

Indications for Use

Indicated for palliative treatment of malignant strictures 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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

Mr. Brian Kunst Vice President, Regulatory Affairs and Quality Assurance AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, New York 12804

Re: K982346

> AngioDynamics AngioStent Biliary Stent System for use in biliary ducts Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: October 30, 1998 Received: November 2, 1998

Dear Mr. Kunst:

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.

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

## Page 2 - Mr. Brian Kunst

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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 the 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,

Susan Alpert, Ph.D., M.D.

Susan Alpert, Ph.D., M.D Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## INDICATIONS FOR USE

510(k) Application: New Application

ANGIODYNAMICS ANGIOSTENT Biliary Stent System Device Name:

Indications for Use:

The ANGIODYNAMICS ANGIOSTENT Biliary Stent System is indicated for palliative treatment of malignant strictures in the biliary tree.

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use