(20 days)
The Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.
The Total Abscession Biliary Drainage Catheters includes a variety of related components including:
- Total Abscession Biliary Drainage Catheter .
- . Stiffening Cannula
- Flexible Cannula .
- Standard Injection Port ●
- Needless Injection Port ●
The Total Abscession Biliary Drainage Catheter family includes 8F, 10F, 12F, and 14F catheters in working lengths of 40cm. The Total Abscession Biliary Drainage Catheter are used to percutaneously drain fluids from the biliary tree.
The provided document is a 510(k) premarket notification for a medical device, specifically the AngioDynamics Total Abscession Biliary Drainage Catheter. It outlines the regulatory approval process and describes the device, its intended use, and comparative testing against a predicate device.
However, the document does not contain any information about a study involving AI, image analysis, computer vision, or machine learning. It focuses on the physical properties and performance of a catheter, specifically material formulation changes and mechanical tests.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, as the input document does not describe such a device or study.
To answer your request, I would need a document detailing an AI-powered medical device and its validation studies.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2017
AngioDynamics, Inc. Teri Juckett Regulatory Affairs Manager 603 Queensbury Avenue Queensbury, NY 12804
Re: K170743
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: March 7, 2017 Received: March 10, 2017
Dear Teri 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Charles Viviano -S
For
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Angiodynamics. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of two interlocking shapes, one in blue and one in red. The company name "angiodynamics" is written in blue, sans-serif font.
510(K) SUMMARY FOR THE ANGIODYNAMICS, INC. TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
Date Prepared: 08 March 2017
| A. | Sponsor: | AngioDynamics, Inc. |
|---|---|---|
| 10 Glens Falls Technical Park | ||
| Glens falls, New York, 12801 | ||
| B. | Contact: | Teri Juckett |
| Manager Regulatory Affairs | ||
| Tel: 518-795-1142 | ||
| Fax: 518-742-4323 | ||
| Email: tjuckett@angiodynamics.com |
Subject (Proposed) Device:
| Trade Name: | AngioDynamics Total Abscession Biliary Drainage Cathete |
|---|---|
| Common Name: | Biliary Drainage Catheters |
| Regulation Number; | 21 CFR 876.5010 |
| Regulation Name: | Biliary Catheter and Accessories |
| Regulatory Class: | Class II, Product Code FGE |
| Classification Panel: | Gastroenterology |
Predicate Device:
| Trade Name: | AngioDynamics Total Abscession Biliary Drainage Catheter |
|---|---|
| 510(k) Reference: | K060023 |
| Common Name: | Biliary Drainage Catheter |
| Regulation Number; | 21 CFR 876.5010 |
| Regulation Name: | Biliary Catheter and Accessories |
| Regulatory Class: | Class II. Product Code FGE |
| Classification Panel: | Gastroenterology |
C. Device Description:
The Total Abscession Biliary Drainage Catheters includes a variety of related components including:
- Total Abscession Biliary Drainage Catheter .
- . Stiffening Cannula
- Flexible Cannula .
- Standard Injection Port ●
- Needless Injection Port ●
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The Total Abscession Biliary Drainage Catheter family includes 8F, 10F, 12F, and 14F catheters in working lengths of 40cm. The Total Abscession Biliary Drainage Catheter are used to percutaneously drain fluids from the biliary tree.
D. Intended Use/Indications for Use:
The Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.
E. Summary of Similarities and Differences in Technology Characteristics and Performance:
The proposed device has similar materials, design, and technical characteristics as the predicate device. The purpose of this 510(k) submission is to introduce into commercial distribution a modified AngioDynamics Total Abscession Biliary Drainage Catheter. There are two modifications. The first modification is a slight change in material formulation for the flexible cannula tubing. The second change is a slight modification to the material formulation used for the slide (hub) of the catheter.
F. Performance Data:
The performance testing included non-clinical bench testing. The following tests were performed.
- · Flexible Cannula Hub to Tubing Tensile and Compression
- · Flexible Cannula Dimensional Testing
- Flexible Cannula Surface finish
- · Flexible Cannula Tip (Visual)
- · Flexible Cannula Advancement and Position
- · Locking Mechanism Retention Force
- · Locking Mechanism "Click"
- · Biocompatibility per ISO 10993-1
G. Conclusion:
Based upon successful results of testing and responses to questions posed within FDA's 510(k) Decision-Making Tree, the proposed device is determined to be substantially equivalent.
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.
§ 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.