The device description of the proposed SMARTTM ControlTM Nitinol Stent Transhepatic Biliary System is as follows. 6 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 6, 7, 8, 9, and10 mm; Stent lengths: 20, 30, 40, 60, 80, and 100 mm; Stent delivery system usable length 80 and 120 cm; and Guidewire lumen 0.035". Proximal Deployment Handle

AI/ML Overview

There is no information in the provided text about a study proving the device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) that would typically be associated with AI/software devices. The document is a 510(k) summary for a medical device (a biliary stent), not an AI algorithm.

Here's a breakdown based on the categories requested, highlighting the lack of information pertinent to AI device studies:

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

Acceptance Criteria: Not explicitly stated as performance metrics. The submission is a 510(k) for a physical medical device (stent), not a software/AI device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to predicate devices, primarily through pre-clinical testing for biocompatibility and mechanical properties.
Reported Device Performance: The document states, "The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate devices. The equivalence was confirmed through pre-clinical testing." No quantitative performance metrics (e.g., accuracy, sensitivity, specificity) are reported, as these are not relevant for this type of device submission.

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

Not applicable. This is a 510(k) for a physical medical device, not a data-driven AI device. There is no mention of a "test set" in the context of data. Pre-clinical testing would involve physical samples of the device.

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)

Not applicable. There is no "ground truth" establishment in the context of data for an AI device.

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

Not applicable.

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 is for a physical medical device (stent), not an AI assistance tool for human readers.

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

Not applicable. There is no algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of what the document does indicate:

Device Type: SMART™ Control™ Nitinol Stent Transhepatic Biliary System (a biliary stent).
Purpose of Submission: 510(k) for demonstrating substantial equivalence to predicate devices.
Method of Proving Equivalence: Pre-clinical testing (likely mechanical, material, and biocompatibility testing) confirmed the device is substantially equivalent to predicate devices.
Key Finding from FDA: The device is substantially equivalent, but a specific warning regarding unestablished safety and effectiveness for vascular use, and clear labeling for biliary use, is required.

Summary

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AUG 1 4 2002

510(k) Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	SMARTTM ControlTM Nitinol StentTranshepatic Biliary System	Biliary Stent
Name ofPredicateDevices	The device is substantially equivalent to:Cordis PreciseTM Nitinol Stent Transhepatic Biliary System (6F) (510(k) #K012993 - October 15, 2001) - Cordis Corporation. S.M.A.R.T.TM Nitinol Stent and Delivery System (Improved Radiopacity)(510(k) # K001843 – July 18, 2000 - Cordis Corporation. Cordis SAVVYTM PTA Balloon Catheter (510(k) # K971010 – June 18,1997) - Cordis Corporation. Bridge SE Self Expanding Stent Delivery System – (510(k) # K011080 –October 11, 2001 - Medtronic AVE Inc.
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act.
Indicationsfor Use	The SMARTTM ControlTM Nitinol Stent Transhepatic Biliary System isintended for use in the palliation of malignant neoplasms in the biliary tree.
DeviceDescription	The device description of the proposed SMARTTM ControlTM Nitinol StentTranshepatic Biliary System is as follows. 6 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalummicromarkers; Expanded stent diameters 6, 7, 8, 9, and10 mm; Stent lengths: 20, 30, 40, 60, 80, and 100 mm; Stent delivery system usable length 80 and 120 cm; and Guidewire lumen 0.035". Proximal Deployment Handle

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All materials used in the SMART™ Control™ Biocompatibility Nitinol Stent Transhepatic Biliary System are biocompatible.

The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is Summary of substantially equivalent to the predicate devices. The equivalence was Substantial confirmed through pre-clinical testing. Equivalence

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 forming its wing, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

Mr. Sam Mirza Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue MIAMI LAKES FL 33014

Re: K021898

Trade/Device Name: Cordis SMART™ Control™ 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: June 15, 2002 Received: July 16, 2002

Dear Mr. Mirza:

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 - Mr. Sam Mirza

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 Quality System Regulation (QS) 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,

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K021898

Device Name: Cordis SMART™ Control™ Nitinol Stent Transhepatic Biliary System

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

The Cordis SMART™ Control™ Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

David G. Symm

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.