(288 days)
The Pruitt Biliary Catheters are intended for use in the removal of stones, ductal debris and the exploration of the biliary tube.
The Pruitt biliary catheter is a radiopaque multi lumen, balloon catheter. The ancillary lumen(s) are for injection and/or irrigation: another lumen inflates the balloon. All materials have been used by Ideas for Medicine, Inc. in cardiovascular catheters and/or laparoscopic instruments with no report of adverse events. All materials have been subject to testing per the Biocompatibility testing.
This document is a 510(k) summary for a medical device (Pruitt Biliary Catheter) submitted in 1996. It describes the device, its intended use, and claims substantial equivalence to existing devices.
The information requested in your prompt (acceptance criteria, details of a study proving device performance, sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.
510(k) summaries from this era (and most 510(k)s) primarily focus on demonstrating substantial equivalence to a predicate device, often through material comparisons, intended use comparisons, and performance data if available, but not typically a detailed clinical study demonstrating meeting specific acceptance criteria in the way envisioned by your prompt for AI/diagnostic devices.
Therefore, I cannot provide the requested information based on the provided text. The document acts as a declaration of substantial equivalence, not a detailed study report.
§ 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.