(30 days)
The Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis POWERFLEX® Plus and OPTA® LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent.
The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is mounted upon its recommended balloon catheter delivery device via the use of accessory devices - plastic crimping tubes, which are provided with the packaged stent, and crimping tools, which are provided separately. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and removed.
The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is provided sterile and is intended for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated via non-clinical design verification tests and analyses. |
| Effectiveness | Demonstrated via non-clinical design verification tests and analyses. |
| Substantial Equivalence | The device is deemed substantially equivalent to predecessor Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stents (K990631 and K991028) based on design, material, components, accessories, method of delivery, fundamental technology, and intended use. The IQ version incorporates a slightly modified stent design, also found to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a clinical test set in the traditional sense of patient data. The safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses." Therefore, there is no information on sample size, country of origin, or retrospective/prospective nature regarding patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that "non-clinical design verification tests and analyses" were conducted, there is no mention of experts establishing a ground truth for a test set based on patient data. The ground truth would have been based on engineering specifications, material properties, and performance metrics established during the design verification process.
4. Adjudication Method for the Test Set
As no clinical test set with patient data is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. The submission focuses on substantial equivalence based on non-clinical data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a medical stent, not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply.
7. Type of Ground Truth Used
The ground truth for demonstrating safety and effectiveness was based on non-clinical design verification tests and analyses. This would involve:
- Engineering specifications and performance targets.
- Material testing results.
- Mechanical property measurements.
- Simulated deployment and expansion tests.
8. Sample Size for the Training Set
This device does not involve a "training set" in the context of an AI or algorithm. The product development would have involved iterative design and testing, but not a dataset used for machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/algorithm mentioned.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent meets its acceptance criteria is a non-clinical design verification study. This study focused on demonstrating the safety and effectiveness of the device through a series of engineering tests and analyses rather than clinical trials with human subjects.
The core of the submission for K992755 relies on establishing substantial equivalence to previously cleared predicate devices (K990631 and K991028). This means that the "IQ" version was shown to be fundamentally the same as its predecessors in terms of:
- Design (with a minor modification to the stent design itself)
- Materials
- Components
- Accessories
- Method of delivery
- Fundamental technology
- Intended use
- Manufacturing methods
- Sterilization methods
Therefore, the "proof" that the device meets acceptance criteria is primarily through the demonstration of its comparable performance to existing, legally marketed devices via non-clinical testing, affirming that the minor design modifications do not introduce new questions of safety or effectiveness.
§ 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.