(69 days)
The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD):
• Used to drain pancreatic ducts
The Advanix™ Pancreatic Stent and NaviFlex™ RX Pancreatic Delivery System and Pushers is a plastic pancreatic stent designed for the delivery of the stent to the pancreatic duct and used to drain pancreatic ducts.
The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, in rounded or tapered leading end tip to facilitate access through papilla, and a rounded trailing end or about the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic or fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.
I regret to inform you that the provided text is a U.S. FDA 510(k) clearance letter and summary for a medical device (Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers).
This type of document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance bench testing and biocompatibility.
Crucially, this document does not contain information about clinical studies with human patients, nor does it establish device performance against specific acceptance criteria in a clinical setting.
Therefore, I cannot extract the information you requested regarding:
- A table of acceptance criteria and the reported device performance: These are not defined in the context of clinical outcomes within this document. The "performance" mentioned refers to bench testing.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set with ground truth established by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: This device is a physical medical device (a stent and delivery system), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the clinical performance criteria you are asking about. The "ground truth" for the bench tests would be the established engineering specifications and standards.
- The sample size for the training set: Not applicable, as there is no training set for a clinical algorithm.
- How the ground truth for the training set was established: Not applicable.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that the submission includes Performance Bench Testing and Biocompatibility Testing. These are standard tests for physical devices to ensure their safety and physical functionality, not their clinical effectiveness in terms of patient outcomes or diagnostic accuracy.
In summary, the provided document is not a study report that demonstrates clinical performance against acceptance criteria for patient outcomes or diagnostic accuracy.
§ 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.