(56 days)
The IntraStent® Mega™ LD (Large Diameter) Stent - Biliary Indication and the IntraStent® Max™ LD (Large Diameter) Stent - Biliary Indication are intended as a palliative treatment of malignant neoplasms in the biliary tree.
The IntraStent Mega and Max LD Stents are balloon expandable stainless steel stents with an open lattice design. The device is provided unmounted, to be manually crimped onto a noncompliant 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.
Medical Device: IntraStent Mega LD and IntraStent Max LD Stents
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test) | Reported Device Performance | Study to prove device meets criteria |
|---|---|---|
| Adherence to performance characteristics of predicate device (IntraStent™ Stent, K991929) | Met the same performance characteristics as the predicate IntraStent™ Stent (K991929). | Bench tests |
| Substantial equivalence in materials, indication for use, and technological characteristics to predicate devices (IntraStent™ Stent K991929 and IntraStent DoubleStrut LD K993904) | The modified IntraStent® stent is identical in materials, indication for use, and technological characteristics to the predicate devices. | Comparison of specifications and characteristics; Performance testing (bench) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample sizes for a human-based test set or any clinical data provenance. The study described is entirely based on bench testing of the devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This was a bench test study, not a clinical study involving experts establishing ground truth from patient data.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device modifications and bench testing for substantial equivalence, not clinical effectiveness studies comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical implant (biliary stent), not a software algorithm or AI. The performance reviewed is mechanical/physical, not algorithmic.
7. Type of Ground Truth Used
The "ground truth" for this submission was the performance characteristics, materials, indication for use, and technological characteristics of the predicate devices (IntraStent™ Stent, K991929, and IntraStent DoubleStrut LD, K993904). The modified devices were compared against these established characteristics of the legally marketed predicate devices to demonstrate substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This submission concerns physical medical devices, not an AI or algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set in the context of an AI or algorithm.
§ 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.