(130 days)
The WallFlex" Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
The proposed 10mm X 40mm Uncovered WallFlex™ Biliary RX Stent System consists of a self-expanding 10mm outer diameter by 40mm length metal stent and a delivery catheter. The proposed stent features Platinum cored Nitinol wires wound together to form a cylinder with proximal and distal flares. The stent is mounted onto a sheath delivery system which is a coaxial tubing assembly. This tubing assembly constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
The manufacturer did not provide specific acceptance criteria with numerical targets. Instead, the performance data focused on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Dimensional Evaluation | Performed similarly to predicate device |
| Radial Expansion Force | Performed similarly to predicate device |
| Radial Compression Force | Performed similarly to predicate device |
| Trackability | Performed similarly to predicate device |
| Deployment Force | Performed similarly to predicate device |
| Reconstrainment Force | Performed similarly to predicate device |
2. Sample Size and Data Provenance for Test Set:
The document does not specify exact sample sizes for each performance test. It states that "Performance testing was completed to establish substantial equivalence." The tests were presumably conducted on the proposed 10mm X 40mm Uncovered WallFlex™ Biliary RX Stent System.
The provenance of the data is not explicitly stated (e.g., country of origin, retrospective or prospective). However, it is an in-house performance test conducted by Boston Scientific Corporation.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This study focuses on engineering performance data of a medical device, not on diagnostic accuracy requiring expert interpretation for ground truth.
4. Adjudication Method:
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.
5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This device is a medical stent, and the study presented here focuses on its physical and mechanical performance compared to a predicate device, not on diagnostic accuracy or reader improvement with AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted in the sense that the device's engineering characteristics were tested independently. The performance tests (dimensional evaluation, radial expansion/compression force, trackability, deployment force, reconstrainment force) were conducted on the proposed device. The results were then compared to the predicate device to establish substantial equivalence.
7. Type of Ground Truth Used:
The "ground truth" in this context refers to the established functional and mechanical properties expected of a biliary stent and, more specifically, the performance characteristics of the legally marketed predicate device (uncovered WallFlex Biliary RX Stent System, K061231). The goal was to show that the new size configuration performed "similarly" to the predicate.
8. Sample Size for Training Set:
Not applicable. This is not a machine learning or AI-based study that would require a "training set."
9. How Ground Truth for Training Set Was Established:
Not applicable. This is not a machine learning or AI-based study.
§ 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.