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 text describes a 510(k) submission for a medical device, the Cordis PALMAZ GENESIS Transhepatic Biliary Stent. The submission focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics in the way a novel device might.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided document, as the regulatory pathway chosen (510(k) for substantial equivalence) typically relies on non-clinical data and comparison to existing devices.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (as per document)
Design, Material, Components, Accessories, Method of Delivery, Fundamental Technology, Intended Use substantially equivalent to predicate device.	"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 PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090)."
Technological Characteristics substantially equivalent to predicate devices.	"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 following predicate Cordis devices: - Cordis PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090); - Cordis PALMAZ GENESIS Transhepatic Biliary Stent on .035 OPTA PRO . Delivery System (see 510(k) #K012590); and, - Cordis PALMAZ Balloon-Expandable Stent for use in the biliary system (see 510(k) . #K905720 and K911581)." "The subject PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 19-59 mm and is designed for expanded diameters of 10-12 mm."
Safety and Effectiveness demonstrated via non-clinical design verification tests and analyses.	"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." (Specific performance metrics are not detailed in this summary.)
Intended Use: Palliation of malignant neoplasms in the biliary tree.	Explicitly stated as the intended use.

Explanation: In a 510(k) for substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through non-clinical testing (e.g., bench testing, mechanical testing, biocompatibility) rather than human clinical trials. The document explicitly states that safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses." The specific parameters and thresholds for these tests are not provided in this summary.

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

Sample size for test set: Not applicable and not mentioned. The document refers to "non-clinical design verification tests and analyses" which typically involve testing devices or components, not "test sets" of data in the context of AI or diagnostic algorithms.
Data provenance: Not applicable. The "data" refers to results from non-clinical tests, not a dataset of patient information.

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

Not applicable and not mentioned. This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the focus of this 510(k) submission.

4. Adjudication method for the test set

Not applicable and not mentioned. This is typically for studies with human readers or image interpretation, not for demonstrating substantial equivalence of a physical stent through non-clinical testing.

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.

No. An MRMC study was not done. This device is a physical stent, not an AI or diagnostic algorithm, so such a study would not be relevant.

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

No. This is a physical medical device (stent), not an algorithm.

7. The type of ground truth used

Non-clinical testing standards and specifications: The "ground truth" for this type of device and submission would be defined by engineering specifications, material properties, mechanical performance thresholds (e.g., radial strength, fatigue life), and biocompatibility standards. These are established through recognized industry standards and internal design requirements. The document refers to "non-clinical design verification tests and analyses," which would assess the device's adherence to these standards.

8. The sample size for the training set

Not applicable and not mentioned. This concept is relevant for machine learning models, not for the regulatory approval of a physical stent through a substantial equivalence pathway.

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

Not applicable and not mentioned. As above, this is for machine learning models.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence for a physical medical device (biliary stent) based on non-clinical data and comparison to existing predicate devices. It is not an AI/algorithm-based device and therefore the questions pertaining to test sets, ground truth, experts, and AI performance metrics are not applicable to this document. The "study" mentioned is the collection of "non-clinical design verification tests and analyses" which demonstrated the device's safety and effectiveness compared to its predicates.

Summary

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K020809
Page 1 of 3

510(k) Summary of Safety and Effectiveness

Submitter:

Cordis Corporation, a Johnson & Johnson Company 40 Technology Drive Warren, New Jersey 07059

(908) 755-8300 Telephone: (908) 412-3915 Fax:

Contact Person:

Donna Marshall Regulatory Affairs Associate II Cordis Corporation, a Johnson & Johnson Company 7 Powder Horn Drive Warren, New Jersey 07059

(908) 412-3844 Telephone: (908) 412-3915 Fax:

Date Prepared:

March 12, 2002

Cordis PALMAZ® GENESIS™ Transhepatic Biliary Trade Name: Stent Biliary Stent and Accessories Common Name: Biliary Catheter and Accessories (per 21 CFR 876.5010) Classification Name: Class II Device Classification:

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 PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090). In short, the subject Cordis PALMAZ GENESIS Transhepatic Biliary Stent represents additional stent lengths and diameters for the dimensional ranges featured with the predicate 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 following predicate Cordis devices:

Cordis PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090); .
Cordis PALMAZ GENESIS Transhepatic Biliary Stent on .035 OPTA PRO . Delivery System (see 510(k) #K012590); and,
Cordis PALMAZ Balloon-Expandable Stent for use in the biliary system (see 510(k) . #K905720 and K911581).

The subject PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 19-59 mm and is designed for expanded diameters of 10-12 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.

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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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2002

Ms. Donna Marshall Regulatory Affairs Associate II Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059

Re: K020809

Trade/Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 12, 2002 Received: March 13, 2002

Dear Ms. Marshall:

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.

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 - Ms. Donna Marshall

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 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 Section 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 Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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

Enclosure

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510(k) Number (if known): K020809

Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent

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
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

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Nancy C Hodgson

Division of Reproductive, Abdominal,
and Radiological Devices K020809
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.