(177 days)
The BONASTENT® Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Bonastent® Biliary stent is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. The stent is made of Nitinol wire and is designed in such a way as to prevent migration and tumor in-growth. The stent is provided preloaded on a delivery device and is available in 2 different diameters (8mm and 10mm) in various lengths.
This document describes the Bonastent® Biliary stent, addressing its substantial equivalence to predicate devices for the palliation of malignant strictures in the biliary tree. However, it does not contain information regarding specific acceptance criteria for performance metrics (such as accuracy, sensitivity, or specificity), nor does it describe any study designed to prove the device meets such criteria.
The document is a 510(k) summary for a medical device cleared by the FDA, which typically focuses on demonstrating substantial equivalence to pre-existing devices rather than independent performance validation studies with acceptance criteria.
Therefore, I cannot provide the requested information from the provided text for the following points:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document focuses on regulatory clearance through substantial equivalence, not on specific performance data against predefined acceptance criteria from a clinical study.
- Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not described.
- 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): Not described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not 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 described. This is a physical medical device (stent), not an AI diagnostic/assistive technology, so such a study would not be applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described.
- The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/algorithm where a training set size would be relevant.
- How the ground truth for the training set was established: Not applicable.
Summary of what is available in the document:
- Device Name: Bonastent® Biliary
- Intended Use: Palliation of malignant strictures in the biliary tree.
- Device Description: Self-expanding polygon mesh surface, tubular prosthesis made of Nitinol wire. Designed to prevent migration and tumor in-growth. Available in 8mm and 10mm diameters in various lengths.
- Technological Characteristics: Weaved using hook & cross wire construction (reduces delivery device diameter). Includes 3 groups of 4 radiopaque markers at the center and both ends.
- Predicate Devices:
- Regulatory Conclusion: EndoChoice believes the device is substantially equivalent to its predicate devices without raising new safety or effectiveness issues.
- FDA Clearance: K093003, cleared on March 24, 2010.
- FDA Imposed Limitations: A warning must appear in the labeling: "The safety and effectiveness of this device for use in the vascular system have not been established." Additionally, the indication for biliary use must be prominently displayed in all labeling.
§ 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.