(64 days)
The ANGIODYNAMICS Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ANGIODYNAMICS Total Abscession Biliary Drainage Catheter). It primarily concerns the regulatory approval based on substantial equivalence to a predicate device and states the indications for use.
This document does not contain any information about:
- Acceptance criteria and reported device performance.
- Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot fulfill your request for this specific input.
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Image /page/0/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
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 (800) 638-2041 or (301) 443-6597 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
§ 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.