(82 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 turnor ingrowth. 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 510(k) submission for the Bonastent® Biliary stent, K140760. This submission is for material changes to the delivery device of an already cleared product (K093003) and not for initial market clearance of a novel device or software. Therefore, the information regarding acceptance criteria, study design for performance, and ground truth establishment is significantly different from what would be expected for a software-as-a-medical-device (SaMD) or a new device effectiveness study.
Based on the provided text, here’s a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" and "reported device performance" are framed around ensuring the safety and effectiveness of the device were maintained despite the material changes to the delivery system. The primary acceptance criterion was that the changes did not negatively impact biocompatibility or mechanical performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Biocompatibility: No new safety issues due to material changes. | Passed Cytotoxicity, Sensitization, and Irritation tests. |
| Deployment: No negative impact on device deployment. | Passed deployment testing. |
| Tensile Strength: No negative impact on device tensile strength. | Passed tensile strength testing. |
| Overall Safety & Effectiveness: Device remains substantially equivalent to the predicate device. | All tests support that no new safety and effectiveness issues are raised due to the changes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for efficacy. Instead, the testing relates to bench testing for the physical device components.
- Sample Size for Bench Tests: Not explicitly stated in terms of number of devices or components. The text mentions "bench tests were performed."
- Data Provenance: N/A for clinical data. This refers to laboratory and bench testing of the device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
N/A. As this submission pertains to material changes and not a clinical efficacy study, there was no "ground truth" derived from expert review of patient data. The "truth" here is established through validated laboratory and engineering tests against predefined specifications for biocompatibility and mechanical performance.
4. Adjudication Method for the Test Set
N/A. There was no clinical test set requiring adjudication from experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is typically conducted for diagnostic devices, especially those involving image interpretation by human readers, to assess the impact of AI on their performance. This 510(k) is for a physical medical device (biliary stent) and material changes to its delivery system, not an AI or diagnostic tool.
6. If a Standalone Performance Study Was Done
Yes, in a way. The "verification & validation activities" including biocompatibility and bench tests (deployment and tensile strength) can be considered standalone performance studies for the modified delivery device, aiming to demonstrate that it performs as intended and meets safety requirements. These studies are focused on the device's intrinsic mechanical and material properties.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" would be the engineering specifications and scientific standards for biocompatibility (e.g., ISO standards for cytotoxicity, sensitization, irritation) and mechanical performance (e.g., predefined force limits for deployment, tensile strength requirements). The results of these tests are compared against these established technical specifications.
8. The Sample Size for the Training Set
N/A. There is no training set mentioned, as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set, this is not applicable.
§ 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.