(76 days)
The IntraStent™ DoubleStrut™ LD Biliary Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree.
The IntraStent™ DoubleStrut™ LD is a balloon expandable stainless steel stent with an open cell design. The stent is provided unmounted, to be manually crimped onto an open lumen PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The provided text describes a 510(k) submission for the IntraStent™ DoubleStrut™ LD Biliary Stent, focusing on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria from a clinical outcome perspective.
Here's an analysis based on the information provided, specifically addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define specific clinical acceptance criteria in terms of performance metrics (e.g., patency rates, complication rates). Instead, the "acceptance criteria" are implied as demonstrating substantial equivalence through bench tests to established predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Meet same performance characteristics as predicate IntraStent™ DoubleStrut™ (K991929) | Bench tests were performed to verify this. |
| Non-pyrogenic | Pyrogenicity testing performed on a lot-to-lot basis supports this claim. |
| Identical materials to predicate devices | Stated as identical to currently marketed IntraStent™ DoubleStrut™ and Cordis Corporation/Johnson & Johnson PALMAZ™ and PALMAZ-SCHATZ™ stents. |
| Identical indication for use to predicate devices | Stated as identical: "palliative treatment for malignant strictures of the biliary tree." |
| Identical technological characteristics to predicate devices | Stated as identical, providing a larger version of IntraStent™ DoubleStrut™ (9-12 mm expanded diameter), fabricated by laser-cutting 316L stainless steel hypotube. |
2. Sample Size Used for the Test Set and Data Provenance
The submission describes bench tests and pyrogenicity testing, not clinical trials with patient data.
- Test Set Sample Size: Not explicitly stated for bench tests (e.g., number of stents tested). For pyrogenicity, it's mentioned as "lot to lot basis," implying samples from manufacturing lots.
- Data Provenance: Not applicable in the context of clinical data (no country of origin or retrospective/prospective clinical data mentioned). The data provenance is from internal bench testing conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for bench tests is the engineering specification and performance of the predicate device. There is no mention of experts establishing a "ground truth" for the test set in the sense of clinical diagnoses or interpretations.
4. Adjudication Method for the Test Set
Not applicable. This concept primarily applies to human reader studies or clinical trials where expert consensus is needed to resolve discrepancies. Bench tests rely on objective physical measurements and compliance with engineering specifications.
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?
Not applicable. This is a medical device (stent), not an AI-powered diagnostic or decision-support system. Therefore, MRMC studies comparing human readers with and without AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (stent), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the performance and characteristics of the legally marketed predicate devices (IntraStent™ DoubleStrut™ K991929 and Cordis Corporation PALMAZ™ and PALMAZ-SCHATZ™ stents). The testing (bench tests, pyrogenicity) aimed to demonstrate that the new device's performance aligns with these established predicates.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI or machine learning device.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (understood as demonstrating substantial equivalence to predicate devices) primarily involved:
- Bench Tests: These were conducted to verify that the IntraStent™ DoubleStrut™ LD met the "same performance characteristics" as the predicate IntraStent™ DoubleStrut™ (K991929). The submission states "Performance testing (bench) further supports a substantial equivalence claim." No specific details about the types of bench tests (e.g., radial force, fatigue, crimp retention) or their results are provided in this summary.
- Pyrogenicity Testing: This was performed on a "lot to lot basis" to support the claim that the device is non-pyrogenic.
The conclusion is that "The collective evidence therefore provides assurance that the IntraStent™ meets the requirements that are considered acceptable for the intended use" by demonstrating its "identical" nature in materials, indication for use, and technological characteristics, and by showing similar performance in bench tests, to its predicate devices.
§ 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.