S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by CORDIS CORP.

The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System is a system consisting of a self-expanding, open mesh, nitinol stent preloaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct.

AI/ML Overview

This document is a 510(k) submission for a medical device (Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System) and focuses on demonstrating substantial equivalence to a predicate device through preclinical testing, rather than reporting on a clinical study with detailed acceptance criteria and performance metrics for an AI-powered device. Therefore, much of the requested information cannot be extracted from this document.

Here's what can be extracted and a clear statement about what information is not present:

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

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device: The device should be substantially equivalent to the currently marketed Cordis S.M.AR.T.™ Nitinol Stent Transhepatic Biliary System.	Equivalence confirmed: "The equivalence was substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing."
Biocompatibility: All materials used in the device should be biocompatible.	Biocompatible: "All materials used in the Cordis S.M.AR.T.™ Nitinol Stent Transhepatic Biliary System are biocompatible."
Intended Use: Device is intended for palliation of malignant neoplasms in the biliary tree.	Meets Intended Use: The device description and indications for use align with this.
Performance Standards: (No specific FDA performance standards established.)	N/A

2. Sample size used for the test set and the data provenance:

Not Applicable. This document describes a traditional medical device (stent) and its submission for substantial equivalence based on pre-clinical testing, not an AI/ML device that would typically involve a "test set" in the context of data. The "pre-clinical testing" mentioned would refer to bench testing and potentially animal studies, but no specific sample sizes or data provenance (country of origin, retrospective/prospective) for a "test set" are provided in relation to an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As this is not an AI/ML device submission, there is no mention of experts establishing ground truth for a test set in this context.

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

Not Applicable. This information is relevant for AI/ML device studies, not for this type of medical device submission.

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. This is a traditional medical device (stent) and not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

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

Not Applicable. This device is a physical medical implant (stent), not an algorithm.

7. The type of ground truth used:

For the purposes of establishing substantial equivalence for this device, the "ground truth" would be the performance and characteristics of the predicate device (Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System) and established engineering/biocompatibility standards. Pre-clinical testing would have likely involved assessments of mechanical properties, deployment characteristics, and biocompatibility, directly compared to the predicate or to defined specifications. The document does not detail the specific methodology of this "pre-clinical testing."

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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510(k) Number (if known): K994068

Device Name:Cordis S.M.A.R.T.TM Nitinol Stent Transhepatic Billiary System__

FDA's Statement of the Indications For Use for device:

The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use______________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

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DEC 2 3 1999

Attachment 4

Summary of Safety and Effectiveness

General Provisions	The name of the device is:
--------------------	----------------------------

Proprietary Name	Common or Usual Name
Cordis S.M.A.R.T. TM Nitinol StentTranshepatic Biliary System	Biliary Stent

Name ofPredicateDevices	The device is substantially equivalent to:
	• Cordis S.M.A.R.T. TM Nitinol Stent Transhepatic Biliary System
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act.
Indications forUse	The Cordis S.M.A.R.T. TM Nitinol Stent Transhepatic Biliary System isintended for use in the palliation of malignant neoplasms in the biliary tree.
DeviceDescription	The Cordis S.M.A.R.T. TM Nitinol Stent Transhepatic Biliary System is asystem consisting of a self-expanding, open mesh, nitinol stent preloaded ontoa sheathed delivery catheter. The delivery system is designed to deliver thestent to the stricture site via transhepatic access. Once positioned at thestricture site, the sheath is withdrawn and the stent is released. Upon release,the stent expands and conforms to the inner lumen of the biliary duct.
Biocompatibility	All materials used in the Cordis S.M.A.R.T. TM Nitinol Stent TranshepaticBiliary System are biocompatible.

Continued on next page

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Summary of Substantial Equivalence

The Cordis S.M.A.R.T.TM Nitinol Stent Transhepatic Biliary System is The equivalence was substantially equivalent to the predicate device. confirmed through pre-clinical testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and a wavy line representing its body.

Public Health Service

DEC 2 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elena S. Jugo, R.A.C. Manager, Regulatory Affairs Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700

K994068 Rc:

Cordis S.M.A.R.T.TM Nitinol Stent Transhepatic Biliary System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: December 1, 1999 Received: December 2, 1999

Dear Ms. Jugo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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Page 2 - Ms. Elena S. Jugo

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( recting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

David W. Brinkley, MD, MPH

David W. Feigal, Jr., M.D., M.P.H. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.