The subject device is a system consisting of a self-expanding, open mesh, nitinol stent preloaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct. The stent is designed to maintain patency of biliary ducts which have been obstructed by malignant neoplasms.

AI/ML Overview

Device Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) Premarket Notification for the Cordis Nitinol Stent & Delivery System. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than establishing specific performance acceptance criteria and then proving the device meets them through a direct clinical trial with predefined endpoints.

Therefore, the "acceptance criteria" here are implicitly centered around demonstrating that the Cordis Nitinol Stent & Delivery System is as safe and effective as legally marketed predicate devices for the palliation of malignant neoplasms in the biliary tree.

Table of Implicit Acceptance Criteria and Reported Performance:

Acceptance Criteria (Implicit from 510(k) Process)	Reported Device Performance (Summary from 510(k))
1. Substantial Equivalence to Predicate Devices: - Comparable design and function. - Comparable intended use. - Comparable technological characteristics. - Comparable safety profile. - Comparable effectiveness for palliation of malignant neoplasms in the biliary tree.	Demonstrated Substantial Equivalence: - The device has a tubular, open mesh design, similar to predicates. - Intended for palliation of malignant neoplasms in the biliary tree, matching predicate indication. - Self-expandable stent, while predicates are self- or balloon-expandable; both types "have been shown to be safe and effective." - Constructed of biocompatible materials, as are predicates. - Delivered percutaneously via a sheathed delivery system, similar to predicate delivery systems (sheathed or balloon). "Both system types have been shown to be safe and effective." - Range of lengths and diameters comparable to predicates, intended to meet clinical need. - "Preclinical testing was conducted which confirmed the safe and effective performance and biocompatibility of the subject device." - "Comparative testing was also conducted which confirmed substantial equivalence of the subject and predicate devices."
2. Safety Profile (Preclinical): - Biocompatibility. - Mechanical integrity. - Delivery system performance.	Confirmed Safety: - Biocompatibility testing was conducted. - "Preclinical testing was conducted which confirmed the safe and effective performance..."
3. Effectiveness (Preclinical): - Ability to expand and maintain patency in simulated biliary ducts.	Confirmed Effectiveness: - "...preclinical testing was conducted which confirmed the safe and effective performance..."

Key takeaway: This 510(k) relies on demonstrating similarity to existing, legally marketed devices (predicates) rather than presenting new clinical acceptance criteria and data for novel claims.

2. Sample Size for Test Set and Data Provenance

The document does not describe a clinical study in human subjects for the Cordis Nitinol Stent & Delivery System that would involve a "test set" of patients.

Instead, the submission relies on:

Preclinical testing: "Preclinical testing was conducted which confirmed the safe and effective performance and biocompatibility of the subject device."
Comparative testing: "Comparative testing was also conducted which confirmed substantial equivalence of the subject and predicate devices."

The specifics of these preclinical and comparative tests (e.g., number of stents tested, type of models used) are not detailed in the provided summary. Therefore, there is no information on:

Sample size used for a clinical test set.
Data provenance (country of origin, retrospective/prospective), as no human clinical data is presented.

3. Number of Experts and Qualifications for Ground Truth

Since no human clinical study or data review (e.g., image interpretation) is described for the purpose of establishing a "ground truth" for a test set, there is no information about:

The number of experts used.
Their qualifications.

4. Adjudication Method for the Test Set

As no clinical test set or review requiring expert consensus is described, there is no information on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is typically performed to evaluate the performance of human readers, often with and without AI assistance, on a set of cases.

The document does not describe an MRMC comparative effectiveness study. Its purpose is to demonstrate substantial equivalence based on device characteristics and preclinical performance, not to evaluate human reader performance or the impact of AI assistance.

6. Standalone Algorithm Performance

This device is a physical medical device (a stent and delivery system), not an algorithm or AI software. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable to this submission.

7. Type of Ground Truth Used

Given that the submission focuses on preclinical testing and substantial equivalence, the "ground truth" refers to:

Preclinical Test Results: Objective measurements of device performance, biocompatibility, and mechanical properties against engineering specifications or established standards.
Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices, inferred from their regulatory clearance and clinical use.

There is no mention of "expert consensus, pathology, or outcomes data" being directly used to establish ground truth for this device's performance in humans within this 510(k) summary.

8. Sample Size for the Training Set

The concept of a "training set" applies to machine learning algorithms. As this is a physical medical device, there is no training set in the context of an AI algorithm. The device development would involve engineering design, prototyping, and iterative testing, but not an algorithmic training set.

9. How Ground Truth for the Training Set Was Established

Again, since there is no AI algorithm or training set, this question is not applicable.

Summary

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DEC 1 8 1998

Cordis Nitinol Stent & Delivery System Cordis, a Johnson & Johnson Company

510(k) Premarket Notification

510(k) SUMMARY

Submitter's name:	Cordis Corporation, a Johnson & Johnson Company14201 NW 60th AvenueMiami Lakes, Florida 33014
Contact person:	Joan MartinManager, Endovascular Regulatory Affairs(908) 412-7250
Date prepared:	March 2, 1998
Trade name:	To be determined
Common name:	Biliary Stent and Delivery System
Classification name:	§876.5010 Biliary Cathether and Accessories
Predicate devices:	Wallstent® Biliary Endoprosthesis with Unistep™ DeliverySystemSymphony™ Nitinol Stent Transhepatic Biliary SystemBard® Memotherm® Nitinol Stent Transhepatic BiliaryEndoprosthesisPALMAZ™ Balloon-Expandable StentPALMAZ™ & PALMAZ-SCHATZ™ Balloon-Expandable Stentand Stent Delivery SystemsLong Medium PALMAZ-SCHATZ™ Balloon-Expandable Stent

Device Description - The subject device is a system consisting of a self-expanding, open mesh, nitinol stent preloaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct. The stent is designed to maintain patency of biliary ducts which have been obstructed by malignant neoplasms.

The Cordis Nitinol Stent and Delivery System is intended for palliation of Labeled Indication: malignant neoplasms in the biliary tree.

Technological Characteristics: The Cordis Nitinol Stent and Delivery System is substantially equivalent in design, function and intended use to currently marketed biliary stents. The subject and predicate stents have a tubular, open mesh design intended for palliation of malignant neoplasms in the biliary tree. The subject stent is self-expandable. The predicate stents are self-expandable or balloon expandable. Both stent types have been shown to be safe and effective. The subject and predicate stents

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Cordis Nitinol Stent & Delivery System Cordis, a Johnson & Johnson Company

510(k) Premarket Notification

510(k) Summary (continued)

and delivery systems are constructed of biocompatible materials. The subject and predicate stents are delivered percutaneously via a delivery system. The subject delivery system is a sheathed delivery system. The predicate delivery systems are either sheathed delivery systems or balloon delivery systems. Both system types have been shown to be safe and effective.

The range of lengths and diameters of the subject and predicate stents are comparable and are intended to meet clinical need.

Nonclinical performance: The differences between the subject and predicate devices are minor and are not relevant to the ability of the subject device to palliate malignant neoplasms in the biliary tree. The descriptive characteristics are precise enough to demonstrate equivalence. Preclinical testing was conducted which confirmed the safe and effective performance and biocompatibility of the subject device. Comparative testing was also conducted which confirmed substantial equivalence of the subject and predicate devices.

Conclusion: The Cordis Nitinol Stent and Delivery System is substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined figures representing the human services aspect of the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1998

Ms. Joan Martin Manager, Regulatory Affairs Cordis Corporation P.O. Box 4917 Warren, New Jersey 07059

Re: K980823

Cordis Nitinol Stent and Delivery System for use in biliary ducts Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: October 28, 1998 Received: October 29, 1998

Dear Ms. Martin:

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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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 Ouality 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 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,

Susan Alpert, Ph.D., M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): To be Assigned

Cordis Nitinol Stent and Delivery System Device Name:

Indications for Use:

The Cordis Nitinol Stent and Delivery System is intended for 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 i (Per 21 CFR 801.109)

OR
Over-the-Counter Use __
(Optional Format 1/2/96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: X980823/S^{ricez}

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.