(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.
§ 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.