(94 days)
This device is used for temporary endoscopic drainage of the biliary duct through the nasal passage by use of an indwelling catheter.
The subject device consists of a drainage catheter, nasal transfer tube, drainage connecting tube and pigtail straightener (provided with drainage catheters which have a pigtail configuration at the distal end). The drainage catheter has anti-migration features, side ports and a touhy-borst connector. The anti-migration features (which include pigtails, duodenal loops and a curved tip) help prevent migration enabling the drainage catheter to remain in the desired position. The side ports, also located at the distal end of the drainage catheter assist in the drainage of bile. The touhy-borst connector allows connection of the drainage catheter to the drainage connection tube; it also allows the drainage catheter to be flushed. The drainage connection tube allows the drainage catheter to be connected to a drainage collection bag. In the middle of the drainage connecting tube is a three way stopcock; this allows a flow through the drainage connecting tube during the procedure. The nasal transfer tube enables the drainage catheter to be threaded through the oral cavity and out through the nostril. The drainage catheter contains radiopaque material which allows the user to ensure the drainage catheter is accurately positioned using fluoroscopically.
The provided document is a 510(k) premarket notification for a medical device (Nasal Biliary Drainage Set) and does not contain information related to software or AI performance testing against acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them for a software/AI context. The document describes a traditional medical device and its substantial equivalence to a predicate device based on manufacturing, materials, and physical performance data, not for an AI/software component.
The performance data section (VII. PERFORMANCE DATA) lists physical and biocompatibility tests like:
- Biocompatibility evaluation (ISO 10993-1)
- Simulated use
- Dimensional verification
- Resistance to collapse
- Flow rate
- Tensile, leakage, radiopacity testing
- Testing (tensile and marker band attachment/corrosion) post exposure to simulated gastric environment (in simulated bile)
- MRI testing
- Shelf life testing
These are typical for physical medical devices and do not involve AI or software performance metrics.
§ 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.