(53 days)
This device is used in palliation of malignant neoplasms in the biliary tree
The Zilver 635® Biliary Stent (ZILBS-635) consists of the following two components: a selfexpanding metal stent and stent delivery system. The stent is a laser cut self-expanding openended cylinder of nitinol. It is a slotted tube that is designed to provide support while allowing conformance to the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining flow in the duct. The ZILBS-635 has radiopaque markers at both ends to assist in fluoroscopic visualization of the stent position. This stent delivery system like the predicate devices allows for co-axial deployment of the stent delivery system accepts a 0.035 inch wire guide. The stent delivery system includes a handle assembly and an introducer assembly. The handle assembly consists of a handle, a wire guide FLLA, holding bushing, a cannula, a check flo hub FLLA/cap and a safety tab. The introducer assembly consists of an outer sheath, an inner carrier and tip. The stent delivery system has an endoscopic pusher ring located on the inner carrier near the proximal end of the loaded stent. The outer sheath has a radiopaque maker band located within the wall of the outer sheath at the distal end. The stent delivery system is supplied with a syringe for flushing through the wire guide FLLA and the check flo hub FLLA.
This document is a 510(k) premarket notification for the Zilver 635® Biliary Stent, seeking substantial equivalence to previously cleared predicate devices. Since this is a submission for a medical device and not an AI/ML product, the information you've requested (acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, etc.) is not applicable or present in the provided text.
The document focuses on demonstrating that the Zilver 635® Biliary Stent (ZILBS-635) is substantially equivalent to existing predicate devices (Zilver® 635™ Biliary Stent and Zilver® Biliary Stent) for the palliation of malignant neoplasms in the biliary tree.
Here's an overview of the information that is available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of AI/ML or a clinical study evaluating effectiveness against specific performance metrics for the device in vivo. Instead, it refers to "Performance Data" which includes:
- Biocompatibility evaluation: Conducted in accordance with FDA's Use of International Standard ISO 10993-1.
- Performance testing: "simulated use, deployment testing, dimensional testing, joint strength testing, MRI and shelf life testing were performed as per Cook's design control system."
The specific quantitative results or acceptance criteria for these tests are not provided in this summary. The general conclusion is that "The non-clinical data supports the safety of the subject device and demonstrates that the Zilver 635® Biliary Stent (ZILBS-635) is safe and effective and should perform as intended in the specified use conditions."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and is not present in the document. The document describes non-clinical performance testing (e.g., biocompatibility, simulated use, mechanical testing) rather than a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and is not present in the document, as it pertains to medical devices and not an AI/ML diagnostic or prognostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not present in the document.
5. 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 information is not applicable and is not present in the document, as it pertains to medical devices and not an AI/ML diagnostic or prognostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and is not present in the document.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and is not present in the document. For a medical device like a stent, "ground truth" would typically refer to the physical and mechanical properties meeting engineering specifications, and evidence of safety and performance in simulated and potentially clinical environments. The document refers to "biocompatibility evaluation," "simulated use, deployment testing, dimensional testing, joint strength testing, MRI and shelf life testing" as the basis for demonstrating safety and effectiveness.
8. The sample size for the training set
This information is not applicable and is not present in the document.
9. How the ground truth for the training set was established
This information is not applicable and is not present in the document.
In summary, the provided text is a regulatory submission for a medical stent, focusing on demonstrating substantial equivalence to predicate devices through engineering and non-clinical performance testing. It does not contain any information related to AI/ML device performance or the specific criteria and studies you've asked about in that context.
§ 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.