MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by CORDIS CORP.

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows. 7 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 12, and 14 mm; Stent lengths: 20, 30, 40, 60, and 80mm; Stent delivery system usable length 80 and 120 cm; Guidewire lumen 0.035" compatible; and Proximal Deployment handle

AI/ML Overview

The provided text is a 510(k) summary for the SMART™ Control™ Nitinol Stent Transhepatic Biliary System. It does not describe a study involving device performance metrics, acceptance criteria, or ground truth establishment in the context of an AI/ML device.

Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The document highlights the device's technical specifications, indications for use, and a comparison to existing, legally marketed stents.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set information, or ground truth establishment methods) because this information is not present in the provided 510(k) summary.

The document only states:

Study that proves the device meets acceptance criteria: "The equivalence was confirmed through pre-clinical testing." (Page 2, Summary of Substantial Equivalence). This refers to pre-clinical testing for biocompatibility and mechanical properties, not a clinical study involving specific performance metrics as might be seen for devices like diagnostic AI.

To elaborate on why each requested point cannot be answered:

A table of acceptance criteria and the reported device performance: Not present. The approval is based on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria for a new type of device performance (e.g., diagnostic accuracy).
Sample size used for the test set and the data provenance: Not applicable to the presented pre-clinical testing for substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established here.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not a diagnostic AI device, so MRMC studies are not relevant in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical medical device (a stent), not an algorithm.
The type of ground truth used: For the pre-clinical testing mentioned, ground truth would relate to material properties, mechanical integrity, and biocompatibility, typically established through standardized in-vitro and in-vivo animal testing, not expert consensus on human data. Specifics are not provided beyond "pre-clinical testing."
The sample size for the training set: Not applicable; this is a physical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K0317777", which appears to be a reference or identification number. Below this, the text "page 1 of 2" indicates that this is the first page of a two-page document.

510(k) Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	SMART™ Control™ Nitinol StentTranshepatic Biliary System	Biliary Stent
Name ofPredicateDevices	The device is substantially equivalent to:Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent Transhepatic Biliary System (510(k) # K021898 – August 14, 2002) - Cordis Corporation. S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System (510(k) # K994068 - December 23, 1999 – Cordis Corporation. Bard LUMINEXX™ 6 Fr Biliary Stent and Delivery System (510(k) # K020682 - April 02, 2002) - C.R. Bard 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 SMART™ Control™ 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 SMART™ Control™ Nitinol StentTranshepatic Biliary System is as follows. 7 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 12, and 14 mm; Stent lengths: 20, 30, 40, 60, and 80mm; Stent delivery system usable length 80 and 120 cm; Guidewire lumen 0.035" compatible; and Proximal Deployment handle
Biocompatibility	All materials used in the SMART™ Control™ Nitinol StentTranshepatic Biliary System are biocompatible.

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K031777
page 2 of 2

The SMARTM ControlTM 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 7 2003

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

Re: K031777

Trade/Device Name: S.M.A.R.T.™ 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 9, 2003 Received: June 10, 2003

Dear Mr. Mirza:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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.

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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.

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 vour 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 (OS) 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 described above is added to your labeling.

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), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

David C. Schultz, M.E.

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): _K031777

Device Name: Cordis S.M.A.R.T.™ Control™ Nitinol Stent Transhepatic Biliary System

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

The Cordis S.M.A.R.T.™ Control™ Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

Nancy C. Hogdon
Division Sign-Off

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.