(28 days)
The Express™ Biliary LD Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.
The 27 mm Express Biliary LD Premounted Stent System will be identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630). The Express Biliary LD Stent is a balloon expandable metallic stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs. The Express Biliary LD Stent is made from 316L surgical grade stainless steel tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, after which it is cleaned and electropolished to obtain smooth rounded struts. The geometry is a continuous pattern consisting of large and small sinusoidal bands connected by axial struts. The deployed stent provides radial strength while conforming to the natural curvature of the anatomy. The stent provides a ghost like image using conventional radiographic imaging equipment. The currently marketed Express Biliary LD Premounted Stent System is offered with stent diameters of 6 - 10 mm, in one mm increments. The 6 - 8 mm diameter stents has lengths of 17 mm, 37 mm, and 57 mm. The 27 mm length is proposed for these stent diameters and is the subject of this submission. These are considered to be the Small Lumen (SL) models. The 9 mm and 10 mm diameter stents have lengths of 25 mm. 37 mm, and 57 mm. These are considered to be the Large Lumen (LL) models. The balloon delivery catheter for the 27 mm Express Biliary LD Premounted Stent System will be identical to the one utilized on the currently marketed Express Biliary LD Premounted Stent Systems (K021630). The Balloon Delivery Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guide wire. The proposed device is designed to be placed over guide wires which have outer diameters of 0.035" or smaller. This lumen can also be used for infusion of contrast medium. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the stenting procedure. The guide wire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.
This document describes the regulatory submission (K024048) for the Boston Scientific Express Biliary LD Premounted Stent System (27 mm). The submission asserts substantial equivalence to a previously marketed device (K021630) and does not contain detailed primary study data or explicit acceptance criteria with numerical performance targets and reported device performance.
Therefore, many of the requested sections regarding specific study details, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from the provided text.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding device performance metrics. Instead, it describes general functional testing and states that "Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Stent Component Functional Testing: | Test results verified adequacy for intended use. |
| - Tensile and elongation | (Implicitly met standards) |
| - Bile corrosion resistance | (Implicitly met standards) |
| - Dimensional verification (strut widths, stent lengths) | (Implicitly met standards) |
| - Foreshortening | (Implicitly met standards) |
| - Recoil | (Implicitly met standards) |
| - Expansion uniformity | (Implicitly met standards) |
| - Compression resistance | (Implicitly met standards) |
| - Over expansion | (Implicitly met standards) |
| - Deployment accuracy | (Implicitly met standards) |
| Balloon Delivery Catheter Functional Testing: | Test results verified adequacy for intended use. |
| - Multiple balloon inflation within a stent | (Implicitly met standards) |
| - Balloon burst within a stent | (Implicitly met standards) |
| - Balloon inflation and deflation time | (Implicitly met standards) |
| - Balloon proximal bond tensile | (Implicitly met standards) |
| - Stent / balloon crossing profile | (Implicitly met standards) |
| - Sheath insertion / withdrawal force | (Implicitly met standards) |
| - Stent securement force | (Implicitly met standards) |
| - Tracking | (Implicitly met standards) |
| - Hub to shaft tensile | (Implicitly met standards) |
| Biocompatibility | Test results verified adequacy for intended use. |
| 2-year product shelf life | Test results verified adequacy for intended use. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document describes non-clinical (functional and biocompatibility) testing. It does not mention clinical data or human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The document describes non-clinical engineering and biological testing, not expert-derived ground truth from clinical cases.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept applies to expert review of clinical cases. The testing described is objective, functional testing.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size of AI Assistance: Not applicable, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable, as this is a medical device (stent system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: For the non-clinical tests described, the "ground truth" would be established engineering specifications, material standards, and validated test methods (e.g., tensile strength, corrosion resistance, dimensional tolerances). There is no reference to expert consensus, pathology, or outcomes data for establishing ground truth in this non-clinical submission.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a medical device, not an AI model, so there is no concept of a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: 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.