PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by CORDIS CORPORATION

The device description of the Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is as follows:
• Delivery system profile in the area of stent housing is .069" (1.75mm) for stent diameters ranging from 5 - 7mm and .079" (2.0mm) for stent diameters ranging from 8 - 10mm.
• The stent will be delivered to the stricture site via the Rapid Exchange Stent Delivery System
• Guidewire lumen - 0.014"
• Stent delivery system useable length - 135cm
• Stent length - 20, 30, and 40mm
• Stent diameters - 5, 6, 7, 8, 9, and 10mm

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies with detailed acceptance criteria for performance in the same way a de novo or PMA submission might.

Therefore, the requested information about acceptance criteria, study design, sample size, expert involvement, and ground truth establishment is not explicitly contained within the provided document. The 510(k) process primarily relies on demonstrating that the new device has "similar technological characteristics" and "is as safe and effective as" a legally marketed predicate device.

However, I can extract information related to the device description and what would typically be considered performance characteristics for such a device, and connect it to the concept of substantial equivalence as the "acceptance criteria" here.

Here's how I can address the request based on the provided text, while also noting the limitations:

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

Since this is a 510(k) submission, the "acceptance criteria" are generally that the new device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" would be presented through a comparison to the predicate device.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Characteristics of the Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System)
Intended Use: Palliation of malignant neoplasms in the biliary tree.	Indications for Use: Intended for use in the palliation of malignant neoplasms in the biliary tree. (Matches predicate's likely indications).
Technological Characteristics: Similar materials, design, and dimensions enabling safe and effective deployment in the biliary tree.	Device Description: • Delivery system profile: 0.069" (1.75mm) for 5-7mm stent diameters, 0.079" (2.0mm) for 8-10mm stent diameters.• Delivery method: Rapid Exchange Stent Delivery System.• Guidewire lumen: 0.014".• Stent delivery system usable length: 135cm.• Stent lengths: 20, 30, and 40mm.• Stent diameters: 5, 6, 7, 8, 9, and 10mm.• Biocompatibility: All materials are biocompatible (implied to be similar to predicate).
Safety and Effectiveness: Demonstrate similar safety and efficacy profile as the predicate device.	Summary of Substantial Equivalence: "The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate device." (This is the primary "reported performance" for a 510(k)). The FDA letter confirms this and adds specific labeling limitations regarding contraindications and prominence of indications for use to ensure safe application.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A) / Not provided. A 510(k) submission typically does not involve a new clinical "test set" in the sense of a prospective clinical trial. The justification relies on comparison to a predicate device, which would have its own historical data. The document does not describe a new clinical study.

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)

N/A / Not provided. Since there's no new clinical test set described, there's no mention of experts establishing ground truth for a new study.

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

N/A / Not provided. No new clinical test set is 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

N/A / Not provided. This device is a physical medical stent, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this device.

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

N/A / Not provided. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A / Not provided. For a 510(k) submission of a physical device like a stent, "ground truth" typically refers to the established performance characteristics and safety profile of the predicate device, which would have been determined through prior clinical studies, literature, and real-world experience (often including pathology or patient outcomes data from those predicate studies). The current document does not detail how the predicate's ground truth was established, as it assumes the predicate is well-understood.

8. The sample size for the training set

N/A / Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

N/A / Not provided. There is no training set for this device.

Summary

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3 2004 AUG

Attachment 4

Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
-----------------------	----------------------------

Proprietary Name	Common or Usual Name
Cordis Precise™ Rx Nitinol StentTranshepatic Biliary System	Biliary Stent

Name ofPredicateDevices	The device is substantially equivalent to:
	• Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System

Classification	Class II
----------------	----------

PerformanceStandards	Performance standards have not been established by the FDA undersection 514 of the Food, Drug and Cosmetic Act.
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Indications forUse	The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System isintended for use in the palliation of malignant neoplasms in the biliarytree.
------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------

DeviceDescription	The device description of the Cordis Precise™ Rx Nitinol StentTranshepatic Biliary System is as follows:
	• Delivery system profile in the area of stent housing is .069"(1.75mm) for stent diameters ranging from 5 - 7mm and .079"(2.0mm) for stent diameters ranging from 8 - 10mm.
	• The stent will be delivered to the stricture site via the RapidExchange Stent Delivery System
	• Guidewire lumen - 0.014"
	• Stent delivery system useable length - 135cm
	• Stent length - 20, 30, and 40mm
	• Stent diameters - 5, 6, 7, 8, 9, and 10mm

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	Biocompatibility All materials used in the Cordis Precise™ Rx Nitinol StentTranshepatic Biliary System are biocompatible.
Summary ofSubstantialEquivalence	The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System issubstantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 - 2004

Ms. Elena S. Jugo Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue MIAMI LAKES FL 33014

Re: K041796

K041790
Trade/Device Name: Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: July 1, 2004 Received: July 6, 2004

Dear Ms. Jugo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 510(x) programially equivalent (for the indications for referenced above and nave acterimined and are are are as marketed in interstate commerce use stated in the enerosure/ to regary that of the Medical Device Amendments, or to devices that provision with 26, 1770, the onlettions and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordantes in the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include Act and the inmual 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 The Office of Device Brandison nas sentified in the proposed labeling and that such use could cause will oc used for an intended ass not reention 513(i)(1)(E) of the Act, the following limitation must appear in the Contraindications section of the device's labeling:

Contraindications:

Use of this product outside the biliary tree. Severe adverse events due to air embolism in . Ose of this product outside the entire) are, and stroke have been reported in connection with use of this product in the carotid arteries.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including r urthermore, the markers, 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 (PMA), it If your device is classified (see above) micr regulations affecting your device can be found
may be subject to additional control . Existing major regulations . FDA may publi may be subject to additional controls. EXIsting major regardent and thion, FDA may publish further
in the Code of Federal Regulations, Title 2 in Parts of Parts . in the Couc of Federal Nog 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 Issualice of a substantal oquirements of the Act or any
FDA has made a determination that your device complies with other was toomply with all FDA has made a determination that your active compless. You must comply with all
Federal statutes and regulations administerial by Line Federation (21 CER Part 807): Federal statutes and regulations administered by other registration and listing (21 CFR Park 807);
the Act's requirements, including, but not limited to: registration and li the Act s requirements, including, but not minited to requirements as set forth in the quality
labeling (21 CFR Part 801); good nanufacturing practice requirements as set for labeling (21 CFR Part 801), good manufacturing procession, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic prod systems (QS) regulation (21-542 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 equivalence or your device to proceed to the market. This results in a classification for your device and perior 3 described in your Section 510(k) premarket
letter will allow you to begin marketing your device as described in your letter will anow you to begin mancemig your ed above is added to your labeling.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labeling mintations are required by a 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 note If you desire spective miorination about the application of Compliance at (301) 594-4616. Also, please note (21 CFR Part 801), please contact the Ories of Compranarket notification' (21 CFR Part 807.97).
the regulation entitled, "Misbranding by reference to premarket notification o the regulation entitled, "Misolanding of responsibilities under the Act from the Division You may other other general mionination on Justice 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,

Donna-Bea Tillman, Ph.D.

onna-Bea Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number: K041796

Device Name: Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System

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

The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is intended for use in the The Cordis Procisionant neoplasms in the biliary tree.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy C. Leighton

(Division Sign-Off) Division of Reproductive, Abdon 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.