(29 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 hand crimped upon its recommended balloon catheter delivery device. 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.
The provided text describes a 510(k) premarket notification for a medical device, the Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of AI/software devices. Therefore, much of the requested information regarding AI device evaluation is not directly applicable or available in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document as it pertains to a traditional medical device (biliary stent) and not an AI/software device. The submission demonstrates substantial equivalence to a predecessor device, not performance against specific, quantifiable acceptance criteria in the manner an AI algorithm would be evaluated. The "Performance Data" section states: "The safety and effectiveness of the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses." However, details of these tests and their acceptance criteria are not included.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/provided. The document refers to "non-clinical design verification tests and analyses" but does not detail a "test set" in the context of evaluating an AI algorithm on data, nor does it mention data provenance for such a test.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/provided. Ground truth establishment by experts is relevant for evaluating diagnostic AI, which is not the subject of this submission.
4. Adjudication Method
This information is not applicable/provided. Adjudication methods are typically used when establishing ground truth for AI model training or evaluation, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable/provided. MRMC studies are used to evaluate the impact of AI on human reader performance, which is not relevant for a physical medical device like a biliary stent.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This submission is not for an AI algorithm.
7. The Type of Ground Truth Used
This information is not applicable/provided. For a physical medical device, "ground truth" might refer to physical properties or clinical outcomes, but it's not discussed in the context of an AI algorithm's performance against a reference standard.
8. The Sample Size for the Training Set
This information is not applicable/provided. The concept of a "training set" is for AI/machine learning models, which this device is not.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided. As above, this pertains to AI/machine learning models.
Summary Related to the Stent Device Itself:
- Device Name: Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent
- Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Technological Characteristics: Balloon-expandable, stainless steel stent, same design, deployment method, materials, technology, delivery devices, and manufacturing processes as the predicate device (K992755), but with longer stent lengths (29-39 mm) and expansion diameters from 4 to 9 mm.
- Proof of Safety and Effectiveness: Demonstrated via "non-clinical design verification tests and analyses." Specific results or acceptance criteria for these tests are not detailed in this summary.
- Regulatory Conclusion: Substantially equivalent to existing predicate devices, allowing it to be marketed. A labeling limitation was added to state that safety and effectiveness for use in the vascular system have not been established.
§ 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.