(29 days)
For percutaneous drainage of abscesses, nephrostomy and other fluids.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a General Purpose Drainage Catheter, stating its substantial equivalence to predicate devices and allowing it to be marketed.
It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or the nature of test sets.
- The number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used (pathology, outcomes data, etc.).
- Training set sample size or how its ground truth was established.
Therefore, I cannot fulfill your request for this specific information based on the text provided.
§ 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.