(182 days)
Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.
Drainage Bag
The provided document is a 510(k) clearance letter from the FDA for a Drainage Bag (K990428). This type of document is a regulatory approval and does not contain information about device acceptance criteria, performance studies, or AI performance metrics as requested in the prompt.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory requirements for marketing the device.
- Stating the intended use of the device.
There is no data presented in this document about clinical studies, test sets, ground truth, or AI performance.
§ 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.