The balloon-expandable PERFLEX Stainless Steel Stent; .
A delivery balloon catheter (either the Cordis PowerFlex or OPTA 5 Balloon . Catheter, depending on the stent size); and,
. An insertion tool.

The Cordis PERFLEX Stainless Steel Stent and Delivery System features a balloonexpandable, stainless steel, welded wire stent that is delivered by a balloon catheter. The stent is provided premounted upon its associated balloon catheter. The Cordis PowerFlex and OPTA 5 Balloon Catheters are used for the delivery of the PERFLEX Stainless Steel Stents. The Cordis PERFLEX Stainless Steel Stent and Delivery System is advanced over a guidewire through a sheath lumen to an obstruction site in the biliary tree where the balloon is inflated to expand the stent. The balloon is then deflated and removed.

Also included with the Cordis PERFLEX Stainless Steel Stent and Delivery System is a stainless steel insertion tool that can be placed within the hemostatic valve of a commercially available introducer sheath to protect the stent / balloon catheter assembly during its insertion. Once the stent/balloon assembly passes through the valve, the insertion tool is removed.

The Cordis PERFLEX Stainless Steel Stent and Delivery System is provided sterile and is intended for single use only.

AI/ML Overview

This document, a 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System, focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness criteria through a new clinical study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific study design, and performance metrics is not present in this submission.

Here's a breakdown of what can be extracted and what is not applicable:

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

This information is not provided in the document. The 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System states: "The safety and effectiveness of the Cordis PERFLEX Stainless Steel Stent and Delivery System have been demonstrated via data collected from nonclinical tests and analyses." It does not provide specific acceptance criteria or reported device performance metrics from a clinical study. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the established safety and effectiveness of those predicates are sufficient.

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

This information is not provided in the document. The submission references "nonclinical tests and analyses," which are typically bench tests or animal studies, not human clinical trials. Thus, there is no "test set" in the context of human data.

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)

This information is not provided in the document. As there is no human "test set" or clinical study with ground truth established by experts, this is not applicable.

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

This information is not provided in the document. Not applicable as there is no human test set requiring adjudication.

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

This information is not provided in the document. MRMC studies are typically for AI/diagnostic imaging devices. This device is a medical implant (stent), and its approval process does not involve MRMC studies or AI assistance.

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

This information is not provided in the document. This is not an AI algorithm but a physical medical device; therefore, "standalone algorithm performance" is not applicable.

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

This information is not provided in the document beyond the mention of "nonclinical tests and analyses." For a physical device like a stent, ground truth in nonclinical tests would likely involve engineering specifications, materials testing results, and potentially animal model outcomes demonstrating mechanical integrity, patency, and biocompatibility, as compared to predicate devices.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" in the context of machine learning or AI. For nonclinical tests, the "sample size" would refer to the number of devices tested, but this detail is not given.

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

This information is not provided in the document. Not applicable, as there is no training set in the context of AI. For nonclinical tests, the "ground truth" would be established by validated measurement techniques and adherence to engineering standards.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The document leverages the concept of substantial equivalence to predicate devices. This means that instead of conducting a new clinical study with specific acceptance criteria, and reporting performance against those criteria, the manufacturer is arguing that their new device is fundamentally similar in design, materials, components, method of delivery, and intended use to devices already cleared by the FDA. The "performance data" mentioned refers to nonclinical tests that confirm the new device's characteristics align with those of the predicate devices and meet established engineering and biocompatibility standards. The FDA's clearance (K980653) confirms that they found the device to be substantially equivalent.

Summary

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JUN - 9 1998

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K980653 1/4

510(k) Summary

Submitter:	Cordis, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059
	Telephone:	(908) 755-8300
	Fax:	(908) 412-3915
Contact Person:	Charles J. RyanManager, Regulatory AffairsCordis, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059
	Telephone:	(908) 412-7446
	Fax:	(908) 412-3915
Date Prepared:	February 10, 1998
Trade Name:	Cordis PERFLEX Stainless Steel Stent and DeliverySystem
Common Name:	Biliary Stent
Classification Name:	Biliary Catheter and Accessories (per 21 CFR 876.5010)
Device Classification:	Class II

Summary of Substantial Equivalence:

The design, material, components, method of delivery, and intended use featured with the Cordis PERFLEX Stainless Steel Stent and Delivery System are substantially equivalent to those featured among predecessor Cordis devices (see 510(k) #K905720, #K911581, #K955728, #K964688, and #K972825) and competitive medical devices, such as the

Continued... Page E2

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Schneider WallStent Biliary Transhepatic Endoprosthesis (see 510(k) #K885180,

#K896163, #K911292, #K914277, #K923993, #K961262, and #K964119).

In short, the Cordis PERFLEX Stainless Steel Stent and Delivery System represents a line extension to the Cordis Biliary Stent and Delivery System (510(k) #K955728).

Device Description:

The Cordis PERFLEX Stainless Steel Stent and Delivery System consists of the following components:

The balloon-expandable PERFLEX Stainless Steel Stent; .
A delivery balloon catheter (either the Cordis PowerFlex or OPTA 5 Balloon . Catheter, depending on the stent size); and,
. An insertion tool.

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The Cordis PERFLEX Stainless Steel Stent and Delivery System is provided sterile and is intended for single use only.

Intended Use:

The Cordis PERFLEX Stainless Steel Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Technological Characteristics:

The Cordis PERFLEX Stainless Steel Stent and Delivery System incorporates the same design, components, method of deployment, materials, and intended use as those found among predicate Cordis metal biliary stents (see 510(k) #K955728 and #K964688). The Cordis PERFLEX Stainless Steel Stent is provided in a range of expanded lengths from 16 to 80 mm and in a range of expanded diameters from 7 to 10 mm.

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4/4

Performance Data:

The safety and effectiveness of the Cordis PERFLEX Stainless Steel Stent and Delivery System have been demonstrated via data collected from nonclinical 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 pre-market 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/4/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo is a stylized eagle with three lines representing the feathers. The text "JUN - 9" is printed below the logo, indicating a date.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chuck Ryan Manager, Regulatory Affairs Cordis 40 Technology Drive Warren, NJ 07059

Re: K980653 Cordis PERFLEX Stainless Steel Stent and Delivery System Dated: May 1, 1998 Received: May 4, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE

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 stated in the enclosure) to 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. 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.

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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number:

Device Name:

Cordis PERFLEX Stainless Steel Stent and Delivery System

Indications For Use:

The Cordis PERFLEX Stainless Steel Stent and Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓ OR Over-The-Counter Use ________(Optional Format 1-2-96)
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Peter R. Salling/

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K980653
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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.