(32 days)
The NIROYAL® Biliary Premounted Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
The NIROYAL® Biliary Premounted Stent System (NIROYAL® Biliary System) is a stent system consisting of a 0.018" balloon delivery catheter and a gold plated stainless steel stent. The modified NIROYAL® Biliary System is the same as the NIROYAL® Biliary System cleared under K003929, with the exception of the delivery balloon size for the 7 mm x 14 mm stent. The 7 mm x 14 mm stent will be mounted on a 20 mm balloon, instead of a 15 mm balloon as described in K003929.
Acceptance Criteria and Device Performance for NIROYAL® Biliary Premounted Stent System
This document outlines the acceptance criteria and the summary of the study performed to demonstrate that the NIROYAL® Biliary Premounted Stent System (with a modified balloon size) meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The following table details the functional testing performed on the modified NIROYAL® Biliary System and the corresponding acceptance criteria. The document states that "Functional testing was conducted to verify the integrity of the modified balloon length of 20 mm for the 7 mm x 14 mm NIROYAL® Biliary System." and implies that the device met these criteria, as substantial equivalence was determined.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tracking Force | 1.5 lbf maximum | Met Acceptance Criteria |
| Stent Deployment Pressure | 103 psi maximum | Met Acceptance Criteria |
| Balloon Burst Pressure Within the Stent | 176 psi minimum | Met Acceptance Criteria |
| Stent Profile | 0.075" maximum | Met Acceptance Criteria |
| Stent Expansion Uniformity at Nominal and Rated Pressure | 5% maximum | Met Acceptance Criteria |
| Stent Foreshortening at Nominal and Rated Pressure | 20% maximum | Met Acceptance Criteria |
| Balloon Burst Pressure Out of the Stent | 176 psi minimum | Met Acceptance Criteria |
| Stent Securement | 0.30 lbf minimum | Met Acceptance Criteria |
2. Sample Size and Data Provenance
The document does not specify the exact sample size used for each functional test. The study appears to be a non-clinical bench test and therefore does not involve human subjects or data from a specific country of origin in the context of clinical trials. The data provenance is internal to Boston Scientific Scimed, Inc. and is generated during product development and modification. This is a retrospective analysis of the modified features against pre-defined engineering specifications.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This study involves functional, non-clinical bench testing of a medical device, not a diagnostic or AI-driven system that requires expert consensus for ground truth.
4. Adjudication Method
Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies. This document describes non-clinical functional testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a submission for a modification to an existing medical device, involving non-clinical functional testing, not an MRMC comparative effectiveness study of a diagnostic AI system.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Non-Clinical Test Summary" section describes various functional tests performed on the device itself, independent of human interaction beyond the execution of the tests. This is a standalone (algorithm/device only) performance evaluation of the physical aspects of the stent system.
7. Type of Ground Truth Used
The "ground truth" for this study is based on engineering specifications and pre-defined performance limits established for the device's functional integrity and safety. These limits (e.g., maximum force, minimum pressure, maximum profile) serve as the objective standards against which the device's performance is measured.
8. Sample Size for the Training Set
Not applicable. This is a medical device modification submission based on non-clinical functional testing, not an AI/ML model that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/ML model; therefore, there is no training set or ground truth established for a training set in this context.
§ 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.