The PALMAZ BLUE Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis SLALOM 0.18" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz BLUE .018 Transhepatic Biliary Stent System) 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 subsequently the delivery system is removed. The Cordis PALMAZ BLUE .018 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

AI/ML Overview

The provided 510(k) summary (K040413) for the Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System details its safety and effectiveness through substantial equivalence to predicate devices, rather than through presenting acceptance criteria and a study demonstrating the device meets those criteria.

Therefore, the requested information elements related to specific acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert reviews, and comparative effectiveness studies are not contained within the provided document.

The document focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices.

Here's a breakdown of what is available regarding safety and effectiveness, based on the provided text, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available. The document does not specify quantitative acceptance criteria or report specific device performance metrics in numerical form. It relies on demonstrating substantial equivalence to predicate devices.

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

Not available. The document states that safety and effectiveness were demonstrated via "non-clinical in-vitro and animal testing (stent placement in biliary duct)". It does not provide sample sizes for these tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective) beyond stating it was non-clinical.

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

Not available. Ground truth establishment by experts for a test set is not described, as the evaluation was non-clinical.

4. Adjudication method for the test set:

Not available. Adjudication methods are not applicable to the non-clinical testing described.

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 device is a transhepatic biliary stent system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.

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

Not applicable. See point 5.

7. The type of ground truth used:

Implied non-clinical data: The document refers to "non-clinical in-vitro and animal testing (stent placement in biliary duct)". The "ground truth" here would likely be derived from measurements, observations, and histological findings from these non-clinical tests demonstrating stent function, patency, and biocompatibility in the animal model. It is not an expert consensus, pathology, or outcomes data from human patients.

8. The sample size for the training set:

Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not applicable. See point 8.

Summary of Studies (from the document):

The document explicitly states:

"The safety and effectiveness of the device and the substantial equivalence to the predicate devices have been demonstrated via data collected from non-clinical in-vitro and animal testing (stent placement in biliary duct) which was prescribed in the FDA's – Guidance for the content of premarket notifications for metal expandable biliary stents. February 5, 1998."
"The Cobalt Chromium based stent material has been tested according to the ISO10993 part 1 and were concluded biocompatible."

The 510(k) submission relies on demonstrating substantial equivalence to already cleared predicate devices, citing similarities in:

Intended use
Components
Dimensions (size range)
Accessories
Method of delivery
Fundamental technology (operating principle)
Packaging configuration and materials
Manufacturing and sterilization processes
Stent material (Cobalt Chromium-alloy, comparing to components in knee implants)

This approach is common for medical devices where a new device is similar enough to an existing one that extensive new clinical trials are not required for market clearance.

Summary

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June 11, 2004

JUN 2 1 2004

K040413
Page 1 of 3

510(k) Summary of Safety and Effectiveness

Submitter

Cordis Europa N.V., Oosteinde 8 9301 LJ Roden The Netherlands

FDA Establishment Registration Number 9610978

Contact	Bert Roossien, Ph.D.Manager, Regulatory AffairsCordis Europa N.V.Oosteinde 89301 LJ RodenThe Netherlands	Tel:	+31 50 50 22 32
Persons:		Fax:	+31 50 50 22 45
			e-mail: broossie@crdnl.jnj.com

alternate contact person

Karen Wilk	Tel:	(908) 412 7257
Manager, Regulatory Affairs	Fax:	(908) 412 3915
Cordis Corporation	e-mail:	kwilk@crdus.jnj.com
7 Powderhorn Drive
Warren, New Jersey 07059
USA

June 11, 2004 Date Prepared:

Device Name and Classification

Trade Name:	Cordis Palmaz® BLUETM .018 Transhepatic Biliary Stent System
Common Name:	Biliary Stent (incl. Accessories)
Classification Name:	21 CFR 876.5010 - Biliary Catheter
Device Classification:	Class II
FDA Classification Panel:	Gastro-enterology
Product Code:	FGE

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June 11, 2004

K040413
Page 2 of 3

Performance Standards / Special Controls

There are no performance standards applicable under section 514 of the Food, Drug, and Cosmetic Act for this device.

The contents of this 510(k) premarket notification have been prepared based upon the FDA's -Guidance for the content of premarket notifications for metal expandable biliary stents. February ર્. 1998

Intended Use

The Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Product Description

Summary of Studies

The safety and effectiveness of the device and the substantial equivalence to the predicate devices have been demonstrated via data collected from non-clinical in-vitro and animal testing (stent placement in biliary duct) which was prescribed in the FDA's – Guidance for the content of premarket notifications for metal expandable biliary stents. February 5, 1998. The Cobalt Chromium based stent material has been tested according to the ISO10993 part 1 and were concluded biocompatible.

Summary of Substantial Equivalency

The intended use, components, dimensions (size range), accessories, method of delivery, fundamental technology (operating principle), packaging configuration and packaging materials, manufacturing and sterilization processes featured with the Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System are substantially equivalent to those featured with the predecessor Cordis PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System. With respect to the stent material (Cobalt Chromium-alloy), substantially equivalence is claimed to the De Puy Anatomic Modular Knee (AMK) Posterior Stabilized

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Image /page/2/Picture/2 description: The image shows handwritten text on a white background. The text at the top reads "K0404B", and below it, the text reads "Page 3 of 3". The handwriting appears to be in black ink and has a casual, cursive style.

Predicate Devices

The following table provides information on the predicate devices.

Device	Company	510k #	Concur Date	Substantial Equivalence
PALMAZ GENESISTranshepatic BiliaryStent on SLALOM.018" DeliverySystem	Cordis Europa, N.V. (partof Cordis Corporation)	K021345	28 Jun 2002	Same intended useSame stent delivery systemSame operating principleSame stent dimensions (diameters& lengths)
PALMAZ GENESISTranshepatic BiliaryStent on SLALOM.018" DeliverySystem	Cordis Europa,N.V. (partof Cordis Corporation)	K012056	1 Aug 2001	Same accessorySame shelf lifeSame packaging materialsSame manufacturing processesSame sterilization processSame sterilization assurance levelof 10-6
Anatomic ModularKnee (AMK)Posterior stabilized	De Puy Inc. (a Johnson& Johnson company)	K901406	23 July 1990	Same material, i.e. (L605) Cobalt-Chromium-alloy (conform ASTMF90) used for stabilizing post ofthe knee system (implant)
Anatomic ModularKnee (AMK)Landmark RevisionKnee	De Puy Inc. (a Johnson& Johnson company)	K925072	21 Jan 1994
Anatomic ModularKnee (AMK)Posterior Stabilized	De Puy Inc. (a Johnson& Johnson company)	K933304	30 August1993

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2004

Albert Roossien, Ph.D. Manager, Regulatory Affairs Manager, Roga N.V., a Johnson & Johnson Company Oosteinde 8 9301 LJ Roden THE NETHERLANDS

Re: K040413

K.040413
Trade/Device Name: Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 11, 2004 Received: June 14, 2004

Dear Dr. Roossien:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we have revewed your section 510(x) promantee is substantially equivalent (for the indications for referenced above and nave decemined the devices marketed in interstate commence
use stated in the enclosure) to legally marketed predicate marketed in the series that use stated in the enclosure) to legally maneted presentation in the managed Commond Commond Commond Commond Commond prior in May 26, 1970, the chaomistic and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the provisions of the general controls provisions of the Act (Act). You may, mercefore, market the be general controls provisions of the Act include Act and the limitations described below. The general someon proctice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that his device and acceld agas I he Office of Device Evaluation has deterfied in the proposed labeling and that such use could cause will be used for an intended use not tuentified in use proper 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 cstablished.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including Furnermore, the murcation for ontary ase mass e, and other promotional materials, in close pouch, 00%, and carter label of a similar point size, and in bold print.

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Page 2 - Albert Roossien, Ph.D.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more replations affecting your device can be found may be subject to additional controls. LAIsting major regardens and thing film may publish further
in the Code of Federal Regulations, Title 2 in Print Books . In addition, In the Couc of I cachar Regarating your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA 's issuance of a substanting with other requirements of the Act or any
FDA has made a determination that your device complies. You must comply with FDA has made a determination that your device oversies. You must comply with all
Federal statutes and regulations administered by other Federations (21 CER Part 807): Federal statures and regulations administerou 05 car registration and listing (21 CFR Part 807); the Act's requirements, including, but not mained on the requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing the collection is product rad labeling (21 CFR Part 801), good manufacturing production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic pro systems (QS) regulation (21-54-14-14-14-14-14-14-14-14-10-1050.
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Please note that the above labeling limitations are required by Section 5 3 (i)(()()() of the Act. Please note that the above labeling innitations are required by a virus ( ( ) ( ) ( ) ( ) ( ) ( ) ( ) ) ) ( ) ( ) ) from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device note If you desire specific information about the applicance at (301) 594-4616. Also, please note (21 CFR Part 801), please contact the Office of Comphanes to offication' (21 CFR Part 807.97).
the regulation entitled, "Misbranding by reference to premarket not from the Di the regulation entitled, "Misolanding by reference to promobilities under the Division
You may obtain other general information on your responsibilities under her You may obtain other general information on your Assistance at its toll-free number or Sman Mandraetar01) 443-6597 or at its Internet address (000) 0500 . fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number: K040413

Device Name: Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System

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

The Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System is indicated for the palliation . The Cordis in the biliary tree.

Prescription Use _L (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Tomm D. Lyson

(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.