ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM by ANGIODYNAMICS, INC.

This document is a 510(k) clearance letter from the FDA for a medical device: the AngioDynamics® Balloon Expandable Biliary Stent System. It approves the device for marketing based on "substantial equivalence" to legally marketed predicate devices.

Crucially, this document does not contain the acceptance criteria of a study or a study that proves the device meets acceptance criteria.

Instead, it indicates:

Marketing Clearance: The device received FDA clearance (K991793) for marketing.
Intended Use: The device is "indicated for palliative treatment of malignant strictures in the biliary tree."
Regulatory Class: Class II (Product Code: 78 FGE).
Limitations/Warnings: The FDA explicitly states, "The safety and effectiveness of this device for use in the vascular system have not been established," and requires this warning to be prominently displayed.

The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring new, full-scale clinical trials proving safety and effectiveness from scratch against predefined acceptance criteria. The document mentions "review of your Section 510(k) notification of intent to market the device," which would have included a comparison to predicate devices and potentially performance data, but that specific data and the associated acceptance criteria are not in these provided pages.

Therefore, I cannot provide the requested information as it is not present in the given text. The document is a regulatory approval, not a scientific study report.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Ms. Teri Juckett Regulatory Affairs Associate AngioDynamics®, Inc. 603 Queensbury Ave. Oueensbury, New York 12804

Re: K991793

AngioDynamics® Balloon Expandable Biliary Stent System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: May 24, 1999 Received: May 26, 1999

Dear Ms. Juckett:

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 - Ms. Teri Juckett

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 (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 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 (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Kimber Richter for

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

Enclosure

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

Page _ 1 of 1

510(k) Number (if known): K991793

Device Name:AngioDynamics® Balloon Expandable Biliary Stent System

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

The AngioDynamics® Balloon Expandable Biliary Stent System is indicated for palliative treatment of malignant strictures in the biliary tree.

Prescription Use / OR
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Szymon
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
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.(b)
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.