(91 days)
The Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The proposed Wallstent RX Biliary Endoprostheses consists of a stent and a delivery catheter. The self-expanding metal stent is delivered endoscopically with the delivery catheter. The stent is a tubular mesh constructed from a biomedical super alloy wire with a tantalum core to allow for visibility under fluoroscopy. The stent is offered bare or covered. The proposed delivery catheter consists of a coaxial tubing assembly that constrains the stent until it is released by retracting the exterior tube assembly. The interior tube of the coaxial system contains a central lumen to accommodate a 0.035" guidewire that exits near the tip of the delivery catheter. Radiopaque markers are located on the interior and exterior tubes to facilitate imaging during stent deployment. The device will be offered in 8mm & 10mm diameters and 40mm, 60mm & 80mm lengths.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (BSC Wallstent Biliary Endoprostheses - K000308, K982184, K964119, & K961262) | Demonstrated Aided by Bench Testing |
Note: The provided document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics. The primary acceptance criterion for this 510(k) submission is the demonstration of "substantial equivalence" to a predicate device.
- Sample Size for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Bench testing was conducted."
- Data Provenance: Not specified, but generally, bench testing involves in vitro or ex vivo laboratory evaluations. It does not typically involve human patient data from a specific country or a retrospective/prospective study design in the same way clinical trials do.
- Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. Bench testing, as described here, typically involves engineering or laboratory testing against defined specifications or predicate device characteristics, not expert-derived ground truth as would be used in an AI/imaging device.
- Adjudication Method for the Test Set:
This information is not applicable. As stated above, bench testing does not involve human expert adjudication in the context of establishing ground truth for a test set.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (a stent and delivery catheter), not an AI-assisted diagnostic tool for human readers.
- Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
This information is not applicable. The device is a physical medical device, not a standalone algorithm.
- The Type of Ground Truth Used:
"Ground truth" in the traditional sense of human expert consensus or pathology is not directly applicable here. For bench testing of a physical device, the "ground truth" would be the established performance characteristics, specifications, and design of the already-marketed predicate device. The performance of the new device would be compared against these known attributes.
- Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not an AI algorithm requiring a training set.
- How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
§ 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.