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

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (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 (see 510(k) #K001258)." "The Cordis PALMAZ GENESIS Transhepatic Biliary Stent incorporates a design, size range, method of deployment, device and packaging materials, fundamental technology, delivery devices, intended use, and manufacturing and sterilization processes substantially equivalent to those featured among the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258) and Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stents (see 510(k)s #K992755 and K994156)."
Safety and Effectiveness for Intended Use	"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."
Compliance with Regulatory Standards	The FDA's 510(k) clearance confirms that the device is "substantially equivalent... to legally marketed predicate devices" and can be marketed "subject to the general controls provisions of the Act." This implies it meets the regulatory standards for its classification.
Intended Use: Palliation of malignant neoplasms in biliary tree	The intended use is clearly stated as "for the palliation of malignant neoplasms in the biliary tree." The device performance is deemed sufficient by the FDA for this stated indication when cleared.
Device Specifications (e.g., size range)	"The PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 12-24 mm and is designed for expanded diameters of 5-8 mm." Performance is considered acceptable for these specifications.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed as "non-clinical design verification tests and analyses."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation was based on non-clinical design verification tests and analyses. This typically refers to bench testing, engineering studies, and material characterization, not patient data in the context of a "test set" as one might find in an AI/software device.
Data Provenance: Not applicable in the context of clinical data for a "test set." The data provenance for the non-clinical tests would be the Cordis Corporation's internal R&D and testing facilities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Given that the study was non-clinical design verification, the concept of "experts establishing ground truth for a test set" in the medical imaging or diagnostic sense is not directly applicable. Expertise would have been in engineering, material science, and regulatory compliance.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable for non-clinical design verification tests. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data where consensus is needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done.
AI vs. Human Improvement Effect Size: Not applicable, as this is a medical device (stent) and not an AI or software-as-a-medical-device (SaMD) being evaluated for human reader assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. This device is a physical medical implant (stent) and does not involve an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical design verification tests would be established through engineering specifications, material standards, mechanical testing results, and established scientific principles relevant to the performance and safety of a medical implant. For example, stent radial strength might be compared against a pre-defined engineering specification.

8. The Sample Size for the Training Set:

This information is not provided and is not relevant. The device is a physical stent developed through traditional engineering and manufacturing processes, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not provided and is not relevant, as there is no "training set" in the context of this device. Development processes would involve design, prototyping, and iterative non-clinical testing against engineering requirements.

In summary, the provided document describes a traditional medical device (stent) clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device and proving safety and effectiveness through non-clinical (bench) testing. It does not involve AI/ML components or clinical performance studies with human readers.

Summary

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KOI 2087

210(k) Summary of Safety and Effectiveness

Submitter:	Cordis Corporation, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059
	Telephone:Fax:	(908) 755-8300(908) 412-3915
Contact Person:	Chuck Ryan, RACManager, Regulatory AffairsCordis Corporation, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059	Telephone: (908) 412-7446Fax: (908) 412-3915
Date Prepared:	July 2, 2001
Trade Name:	Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent
Common Name:	Biliary Stent and Accessories
Classification Name:	Biliary Catheter and Accessories (per 21 CFR 876.5010)
Device Classification:	Class II

Summary of Substantial Equivalence:

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 (see 510(k) #K001258). In short, the subject Cordis PALMAZ GENESIS Transhepatic Biliary Stent represents an unmounted (provided separately from its delivery catheter) line extension to this predecessor device.

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Device Description:

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

Intended Use:

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

Technological Characteristics:

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent incorporates a design, size range, method of deployment, device and packaging materials, fundamental technology, delivery devices, intended use, and manufacturing and sterilization processes substantially equivalent to those featured among the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258) and Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stents (see 510(k)s #K992755 and K994156). The PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 12-24 mm and is designed for expanded diameters of 5-8 mm.

Performance Data:

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.

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 premarket 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Bockville MD 20850

AUG 0 1 2001

Mr. Chuck Ryan, RAC Manager, Regulatory Affairs Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059

K012087 Re:

Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent (12-24 mm Lengths) Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 2, 2001 Received: July 3, 2001

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 atore 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 - Mr. Chuck Ryan, RAC

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see acchiect to such additional controls. Existing major regulations (Premarket Apployal), it may of sacree of Federal Regulations, Title 21, Parts 800 to 895. affecting your do rive can determination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS Medical Devices. General regalation (FDA) will verify such assumptions. Failure to inspections, the Food and Drag Framilias in tegulatory action. In addition, FDA may publish Comply with the GMT regaranting 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 The IDA in a classification for your device and permits your device to proceed to the market. This resuris in a clussified.com rour 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. I herefore, 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 If you desire specific images as a onaly 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, advertising or your de ison 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,

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K012087

Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent (12-24 mm Lengths)

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

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

Prescription Use OR
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David G. Segura

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.