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

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Koi 2090

510(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 3, 2001
Trade Name:	Cordis PALMAZ® GENESIS™ Transhepatic BiliaryStent
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 with the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258) and Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stents (see 510(k) #K991028). The PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 29-79 mm and is designed for expanded diameters of 5-10 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

AUG 0 1 2001

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

K012090 Re:

Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent (29-79 mm Lengths) Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 3, 2001 Received: July 5, 2001

Dear Mr. Ryan:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed four betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the onerobars, to regarly ent date of the Medical Device Amendments, or to devices that provisions of the 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 Cosincite Act (ree). - For the Jy uitations described below. The general controls provisions of the provided of an irements 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 The Office of Dories Draintended 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, i attivitiors, the historials 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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 (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 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,

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): K012090

Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent (29-79 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 ما OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Segman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 1017 090 510(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.