(128 days)
The PALMAZ CORINTHIAN Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Certain sizes of the OPTA LP catheters are indicated for deployment of 6-10 mm diameter x 4-10 cm length PALMAZ CORINTHIAN Transhepatic Biliary Stents. The clinical indications for these stents are described in their Instructions for Use.
Additionally, the OPTA LP catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent.
The Cordis PALMAZ CORINTHIAN 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 Transhepatic Biliary Stent and the OPTA LP Balloon Catheter are provided sterile and are intended for single use only.
The provided text describes a 510(k) submission for the Cordis PALMAZ® CORINTHIAN™ Transhepatic Biliary Stent and OPTA LP Catheter. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a standalone study with defined acceptance criteria and performance metrics for this new device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the new device. The primary "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: The document states: "The safety and effectiveness of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and its OPTA LP Balloon Catheter delivery device have been demonstrated via data collected from non-clinical design verification tests and analyses."
- No specific performance metrics (e.g., success rates, complication rates, longevity) from these tests are provided.
- The document mentions the stent's physical characteristics: "The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is provided in a range of nominal, unexpanded lengths from 40 to 100 mm and can be expanded to diameters from 6 to 10 mm." This describes its physical capabilities rather than a performance outcome.
| Acceptance Criteria (Inferred for Substantial Equivalence) | Reported Device Performance (From non-clinical verification) |
|---|---|
| Equivalence in design, material, components, accessories, method of delivery, fundamental technology, and intended use to predicate Cordis biliary stents. | "The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent incorporates the same method of deployment, materials, fundamental technology, intended use, and methods of manufacturing and sterilization as those found with its predicate Cordis Long Medium PALMAZ-SCHATZ Balloon-Expandable Stents (see 510(k) #K964688)." |
| "The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent incorporates a modified stent design that is substantially equivalent to that found with predicate Cordis metal biliary stents (see 510(k)s #K905720, #K911581, and #K964688)." | |
| Equivalence of the OPTA LP Balloon Catheter to predicate Cordis balloon catheters for biliary stent deployment. | "The Cordis OPTA LP Balloon Catheter delivery device recommended for use with the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent represents a line extension to other Cordis balloon catheters that were previously determined substantially equivalent for biliary stent deployment (see 510(k) #K990631)." |
| "Aside from the added indication for use as a delivery device for the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent, the Cordis OPTA LP Balloon Catheter remains identical to itself as represented in 510(k) #K971448 and #K981407 for use as a dilatation catheter." | |
| Demonstrated safety and effectiveness through non-clinical testing. | "The safety and effectiveness... have been demonstrated via data collected from non-clinical design verification tests and analyses." (No specific results provided) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/not stated in the document. The submission relies on "non-clinical design verification tests and analyses" and comparison to predicate devices, not a clinical test set in the traditional sense for evaluating device performance.
- Data Provenance: The data is described as "non-clinical design verification tests and analyses." This typically means laboratory testing, material characterization, and engineering analyses, not retrospective or prospective clinical human data from a specific country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. Since this is a 510(k) submission focused on substantial equivalence and non-clinical testing, there is no mention of experts establishing ground truth for a clinical test set. The FDA regulators are the experts who evaluate the substantial equivalence claim.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done. The submission is for a medical device (stent and catheter), not an AI algorithm, and focuses on substantial equivalence based on physical and functional characteristics, not on improving human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This document describes a physical medical device (stent and catheter), not an artificial intelligence algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and effectiveness profile of the predicate devices. The new device's characteristics are compared against these known, approved devices. For the non-clinical design verification, the "ground truth" would be established engineering specifications, material properties, and performance benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
In Summary:
This document is a 510(k) summary demonstrating substantial equivalence for a medical device. It does not contain information about clinical acceptance criteria or a study designed to prove device performance against such criteria in the way one might expect for an AI/algorithm submission. Instead, the proof of safety and effectiveness relies on its similarity to already-approved predicate devices and non-clinical design verification tests, which are not detailed in this summary. The FDA's letter in the provided text indicates their determination of substantial equivalence, allowing the device to be marketed.
§ 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.