ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER

K060023 · AngioDynamics, Inc. · FGE · Mar 9, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060023
• Device Name: ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
• Applicant: AngioDynamics, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANGIODYNAMICS Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.

Device Story

The AngioDynamics Total Abscession Biliary Drainage Catheter is a medical device used for percutaneous transhepatic biliary drainage. It is designed to facilitate the drainage of bile from the biliary tree. The device is intended for use by physicians in a clinical or hospital setting. It functions as a drainage catheter to relieve biliary obstruction or manage biliary conditions. The device is placed percutaneously under imaging guidance to provide a pathway for bile to exit the body, thereby aiding in patient decompression and symptom management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Biliary drainage catheter; class II device under 21 CFR 876.5010; product code FGE. Materials and specific dimensions are not detailed in the provided text.

Indications for Use

Indicated for percutaneous transhepatic biliary drainage in patients requiring biliary decompression.

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)

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2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Teri Juckett Regulatory Affairs Manager AngioDynamics, Inc. 603 Queensbury Avenue QUEENSBURY NY 12804

Re: K060023

> Trade/Device Name: ANGIODYNAMICS Total Abscession Biliary Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 9, 2006 Received: February 10, 2006

MAR 9

Dear Ms. Juckett:

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms leter with anon-you to vegal inding of substantial equivalence of your device to a legally prematication: "The PDF mainly sification 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR And production the regulation on your responsibilities under the Act from the 001:37): " Cormal Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrl/industry/support/index.html.

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

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K060023 page 1 of 1

Confidential

## INDICATIONS FOR USE

510(k) Application: Special 510(k) Device Modification

Device Name: ANGIODYNAMICS Total Abscession Biliary Drainage Catheter

## Indications for Use:

The ANGIODYNAMICS Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tancy bradlen

Division of Reproductive, Abdo and Radiological Devices 510(k) Number