FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.

The Cordis PALMAZ GENESIS 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 GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent). This type of document focuses on demonstrating substantial equivalence to a previously approved device, rather than proving performance against specific acceptance criteria through a clinical trial or a standalone study.

Therefore, many of the requested points, especially those related to acceptance criteria, specific device performance numbers, and study designs (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance), are not typically found or required in a 510(k) submission for this type of device.

Here's an analysis based on the provided text, addressing what can be found and explicitly stating what cannot:

1. A table of acceptance criteria and the reported device performance

Not Applicable / Not Provided. This document does not describe acceptance criteria in terms of quantitative performance metrics for a specific study, nor does it report specific device performance numbers against such criteria. The focus is on demonstrating "substantial equivalence" to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Provided. No test set, sample size, or data provenance information (country, retrospective/prospective) is included. The demonstration of safety and effectiveness relies on "non-clinical design verification tests and analyses" and substantial equivalence to a predicate, not a clinical study on a human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided. There is no mention of experts establishing a ground truth for a test set, as no such clinical test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. No adjudication method is described, as there is no clinical test set requiring expert review.

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 / Not Provided. This device is a transhepatic biliary stent, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant and not part of this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable / Not Provided. This is a physical medical device (stent), not an algorithm. Standalone performance for an algorithm is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided. No clinical ground truth is described in the context of this 510(k) summary. The "ground truth" for demonstrating device compliance would be based on engineering specifications and bench testing against the predicate device's characteristics.

8. The sample size for the training set

Not Applicable / Not Provided. No training set is mentioned or relevant for this type of device submission.

9. How the ground truth for the training set was established

Not Applicable / Not Provided. As there is no training set, there is no ground truth establishment for it.

Summary of what the document does provide regarding device performance and equivalence:

The document states:

"The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses."
The device is "substantially equivalent to those featured with the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258)."
The "design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ GENESIS Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis BX Transhepatic Biliary Stent and Delivery System."

In essence, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating that the new device shares fundamental technological characteristics, intended use, and similar performance to the predicate device through non-clinical testing, rather than meeting specific quantifiable performance metrics from a new clinical study.

Summary

Regulation Number and Section

§ 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.