(25 days)
Cannulation of the Papilla of Vater to deliver contrast medium for fluoroscopic visualization of the biliary/pancreatic system.
The ProFormaTM HF 4.5 Cannula is used for endoscopic cannulation of the biliary ductal system. With a tapered, atraumatic tip, and high flow injection port, this device provides cannulation of the papilla and access into the biliary system. The 4.5 French tip accepts a 0.035" (0.889 mm) guidewire. The unique multi-lumen port design at the proximal end, allows for injection of contrast medium through two lumens with a separate port for guidewire passage.
Colored visual markers located on the distal tip endoscopically aid in the assessment of cannulation and insertion into the biliary system. A distal radiopaque maker band aids in fluoroscopic visualization. A proximal marker band indicates when the catheter exists the duodenoscope.
The provided K050777 document does not contain information about a study proving device performance against acceptance criteria for an AI/ML powered device.
This document describes a 510(k) submission for a medical device called the "ProForma™ HF 4.5 Cannula," which is used for endoscopic cannulation of the biliary ductal system. The submission is from 2005, significantly predating the widespread use and regulatory framework for AI/ML in medical devices.
Therefore, I cannot fulfill your request for information related to acceptance criteria and a study proving an AI/ML device meets them based on this document. The document focuses on establishing substantial equivalence for a physical medical device based on its technological characteristics, biocompatibility, and functionality testing, not on the performance of a software algorithm.
§ 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.