(147 days)
The GI Supply Biliary Stent is a disposable single-use device intended for use to temporarily by-pass obstructions in the biliary tree and allow drainage into the duodenum.
The GI Supply Biliary Stent is a disposable single-use device.
The provided FDA document is a 510(k) clearance letter for the GI Supply Biliary Stent. This type of document does not typically contain detailed information about the acceptance criteria, study design, or performance metrics that would be associated with a diagnostic AI/ML device.
The 510(k) process for a device like a biliary stent primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing (physical and mechanical properties), biocompatibility, and sometimes limited animal or human clinical data to assess safety and performance in a non-inferiority context. It does not involve AI model development or the detailed validation studies you've asked about for AI-driven diagnostics.
Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is a biliary stent, intended for temporarily bypassing obstructions in the biliary tree and allowing drainage into the duodenum. There is no mention of AI, machine learning, image analysis, or diagnostic functions within this document.
If you have a document pertaining to an AI/ML diagnostic device, please provide that, and I would be happy to analyze it for the requested details.
§ 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.