(161 days)
The Boston Scientific Express™ Biliary LD Premounted Stent System is intended for the palliation of malignant neoplasms in the biliary tree.
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 excellent radial strength while conforming to the natural curvature of the anatomy. The stent provides a ghost like image using conventional radiographic imaging equipment. The Express Biliary LD Stent will be offered in Small Vessel (SV) and Large Vessel (LV) models. The SV model will be used for vessel diameters ranging from 6 mm through 8 mm, with lengths of 17 mm, 37 mm, and 57 mm. The LV model will be used for vessel diameters of 9 mm and 10 mm with lengths of 25 mm, 37 mm, and 57 mm.
The Express Biliary LD balloon delivery catheter will be substantially equivalent to the legally marketed Boston Scientific Ultra-thin SDS Balloon Dilatation Catheter (K011889 and K011909). The delivery catheter is identical to the predicate catheter with the exception of one minor component and material change and one design change associated with the number of balloon folds. The hub utilized for the delivery catheter will be the hub design currently used on the Boston Scientific Synergy Balloon Dilatation Catheter (submitted under the name SC 35 Balloon Dilatation Catheter), cleared to market under K993303 and K993305. 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 guidewire. The proposed device is designed to be placed over guidewires 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 guidewire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.
The provided document does not contain acceptance criteria for device performance in the traditional sense of a study with quantitative metrics and statistical analysis. Instead, it describes a 510(k) premarket notification for a medical device (Boston Scientific Express Biliary LD Premounted Stent System), which focuses on demonstrating substantial equivalence to a predicate device already on the market.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of regulatory submission.
However, I can extract information related to the non-clinical testing performed to establish this substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific numerical acceptance criteria alongside quantifiable reported device performance in the typical scientific study format. Instead, it lists various functional tests and concludes that the test results "verified that the Express Biliary LD Premounted Stent System is adequate for its intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter." Essentially, the "acceptance criteria" here implicitly mean passing these functional tests to demonstrate similar performance to the predicate device.
| Functional Component | Functional Tests Performed | Stated Performance (Implicit Acceptance) |
|---|---|---|
| Stent | Tensile and elongation | "Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter based on a comparison of intended use, the design, and the results of in-vitro testing and evaluation." This statement applies to all functional tests. For the shelf life testing, "the data must show acceptable results after 2 years accelerated aging in order to claim the labeled shelf life of two years." |
| Bile corrosion resistance | ||
| Dimensional verification (strut widths, stent lengths) | ||
| Foreshortening | ||
| Recoil | ||
| Expansion uniformity | ||
| Compression resistance | ||
| Over expansion | ||
| Deployment accuracy | ||
| Balloon Delivery | Multiple balloon inflation within a stent | |
| Catheter | Balloon burst within a stent | |
| Balloon inflation and deflation time | ||
| Balloon proximal bond tensile | ||
| Stent / balloon crossing profile | ||
| Sheath insertion / withdrawal force | ||
| Stent securement force | ||
| Tracking | ||
| Hub to shaft tensile | ||
| Biocompatibility | Biocompatibility testing | "Biocompatibility has also been conducted. Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use..." |
| Shelf Life | Accelerated aging (for 2 years shelf life claim) | "Product shelf life testing will be conducted and the data must show acceptable results after 2 years accelerated aging in order to claim the labeled shelf life of two years." (This is a forward-looking statement, indicating future compliance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes (e.g., number of stents or catheters tested) for any of the functional or biocompatibility tests.
- Data Provenance: The tests are described as "Non-clinical Test Summary" and "in-vitro testing and evaluation." This indicates that the tests were conducted in a laboratory setting, likely by the manufacturer (Boston Scientific Corporation, One Scimed Place, Maple Grove, Minnesota), rather than involving human clinical data. Therefore, country of origin related to patient data, retrospective/prospective, are not applicable.
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)
- This information is not applicable as the tests described are functional and biocompatibility bench/in-vitro tests, not clinical evaluations requiring expert interpretation of patient data or images to establish a "ground truth" for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable for the same reasons as point 3. These are non-clinical engineering and biological tests, not clinical studies with subjective evaluation that would require adjudication.
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
- An MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (stent system), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable, as the device is a physical medical stent system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" would be established by objective, verifiable engineering and scientific standards (e.g., direct measurements of dimensions, standardized material property tests, established biocompatibility protocols). There's no "expert consensus" or "pathology" in the human diagnostic sense involved.
8. The sample size for the training set
- This is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The device itself is what was tested.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as point 8.
§ 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.