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.

AI/ML Overview

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.

Summary

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K994156

Page 1/3

JAN - 7 2000

Submitter:	Cordis Corporation, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059Telephone: (908) 755-8300Fax: (908) 412-3915
Contact Person:	Chuck Ryan, RACManager, Regulatory AffairsCordis Corporation, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059Telephone: (908) 412-7446Fax: (908) 412-3915
Date Prepared:	December 8, 1999
Trade Name:	Cordis PALMAZ® CORINTHIAN™ IQ TranshepaticBiliary Stent
Common Name:	Biliary Stent and Accessories
Classification Name:	Biliary Catheter and Accessories (per 21 CFR 876.5010)
Device Classification:	Class II

510(k) Summary of Safety and Effectiveness

Summary of Substantial Equivalence:

The design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ CORINTHIAN IQ Transhopatic Biliary Stent are substantially cquivalent to those featured with the predecessor Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stents (see 510(k) :: K 992755). In short, the subject Cordis PALMAZ CORINTHIAN IQ Transhepatic Billiary Stent represents a line extension to these predecessor stents.

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Device Description:

The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is provided sterile and is intended for single use only.

Intended Use:

The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.

Technological Characteristics:

The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent incorporates the same design, method of deployment, device and packaging materials, fundamental technology, delivery devices, intended use, and manufacturing and sterilization processes as those featured with the predicate Cordis PAL.MAZ CORINTHIAN IQ Transhepatic Biliary Stents (see 510(k) #K992755), except that the subject Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent features longer stent lengths (29-39 mm) and can be expanded to diameters from 4 to 9 mm.

Performance Data:

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.

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K994156 Page 3/.

510(k) Premarket Notification

A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the stated, "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with three curved lines extending from its head, resembling feathers or wings. The image is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 JAN

Mr. Charles J. Ryan, RAC Manager, Regulatory Affairs Cordis, a Johnson & Johnson Company P.O. Box 4917 Warren, New Jersey 07059

Re: K994156

Cordis PAI.MAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: December 8, 1999 Received: December 9, 1999

Dear Mr. Ryan:

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.

I he 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 Warmings section of the PALMAZ* CORINTHIAN™ IQ Transhepatic Billiary Stent'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 stent labeling, mcluding 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 - Mr. Charles Ryan

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 affecting 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 e purments as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (1) (1 R 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 vour 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.

II vou 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 Complance at (30) ) 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,

Daniel W. H

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

Enclosure

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Page __ 1 of_1

510(k) Number (if known): K994156

Device Name: __ordis PALMAZ® CORINTHIANI™ IQ Transhepatic Biliary Stent

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

The Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.

ાર Prescription Use_V (Per 21 CFR 801 109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Signature

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device: 510(k) Number

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.