(18 days)
The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
The Zilver® 518 and 635TM Biliary Stent is a self-expandable stent made of nitinol. The special laser-cut pattern of the nitinol tube provides a construction with strong radial force and high flexibility. It is a slotted tube that is designed to provide support while maintaining flexibility in 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 constant flow in the duct. The stent has radiopaque markers (gold rivets) at both ends to assist in fluoroscopic visualization of the stent position. The delivery system for both ZIB5 and ZIB6 devices includes a handle assembly and an introducer catheter assembly. The Zilver® 518 and 635™ Biliary Stent is mounted on the inner catheter of the delivery system and is restrained by an outer sheath. The delivery system is used to deliver the stent to the appropriate location. The stent is deployed by retracting the outer sheath while holding the central metal cannula stationary. Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent is placed using fluoroscopic and percutaneous techniques.
This is a 510(k) premarket notification for a medical device, not an AI/ML-powered device. Therefore, the common acceptance criteria and study information typically associated with AI models (such as AUC, sensitivity, specificity, MRMC studies, training/test set details, and ground truth establishment) are not applicable.
The document describes the Zilver® 518™ Biliary Stent and Zilver® 635™ Biliary Stent, which are physical medical devices (self-expandable stents). The submission, K182980, is for a modification to the instructions for use of an already cleared device (K163169).
Here's a breakdown of the relevant information provided in the context of the device:
1. A table of acceptance criteria and the reported device performance:
Since this is a submission for a modification to "Instructions for Use" and not a new device or a device with new functionality requiring performance metrics, there are no specific performance acceptance criteria or reported device performance metrics in the typical sense (e.g., accuracy, sensitivity). The "acceptance criteria" here relate to demonstrating substantial equivalence for the modified labeling.
The key "acceptance criteria" for this 510(k) appears to be:
- Substantial Equivalence: The modified device (with updated IFU) must be substantially equivalent to the predicate device (Zilver® 518™ and 635™ Biliary Stent, K163169).
Reported Device Performance:
The document explicitly states: "There were no device changes, therefore no additional testing was required to support the determination of substantial equivalence to the predicate devices." This implies that the performance of the device itself (mechanical, biological, etc.) was already established with the predicate device submission (K163169) and is implicitly considered to meet all relevant performance standards. The current submission does not present new performance data.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of evaluating an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI model requiring "ground truth" establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In summary: This document is related to a Class II medical device (biliary stent), and the 510(k) submission is specifically for changes to the Instructions for Use (IFU). It asserts substantial equivalence to a previously cleared predicate device (K163169) and states that no additional testing was required because there were no changes to the device's design or materials, only to the labeling. Therefore, the questions related to AI/ML model performance evaluation do not apply to this submission.
§ 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.