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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.

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.

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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:

1. 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.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not described.
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): Not described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not described.
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 described. This is a physical medical device (stent), not an AI diagnostic/assistive technology, so such a study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described.
8. 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.
9. 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:
  • Niti-S Biliary Stent by Taewoong Medical Co., Ltd, K073667
  • WallFlex™ Biliary RX Stent System by Boston Scientific Corporation, K081733
• 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.

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