(50 days)
For percutaneous drainage of abscess, nephrostomy and other fluids.
Uresil General Purpose Drainage Catheters
This is a 510(k) premarket notification for a medical device (Uresil Percutaneous Drainage Catheters), which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as one would expect for a novel AI/software device.
The document is an FDA clearance letter based on substantial equivalence to pre-amendment devices, indicating that the device is a well-established type of medical product.
To answer your specific questions based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document is a 510(k) clearance letter based on substantial equivalence, not a performance study against specific acceptance criteria for a new device.
- Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
- Adjudication method: Not applicable. No test set or ground truth establishment is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical catheter, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical catheter.
- The type of ground truth used: Not applicable. No ground truth is described.
- The sample size for the training set: Not applicable. This is a physical medical catheter, not an AI/software device requiring a training set.
- How the ground truth for the training set was established: Not applicable. This is a physical medical catheter.
In summary, the provided document is a regulatory approval for a physical medical device (catheter) under the 510(k) pathway, which focuses on substantial equivalence. It does not involve the type of performance study and acceptance criteria evaluation typically associated with novel diagnostic devices, especially AI/software-based ones.
§ 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.