MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by CORDIS CORP.

The device description of the proposed Precise™ Nitinol Stent Transhepatic Biliary System (6F) is as follows.
• 5 / 6 French stent delivery system profile;
• Stent material – Nickel Titanium alloy;
• Expanded stent diameters 8, 9, and 10 mm;
• Stent lengths: 20, 30, and 40 mm;
• Stent delivery system usable length 135 cm; and
• Guidewire lumen 0.018".

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Precise™ Nitinol Stent Transhepatic Biliary System (6F)". This document focuses on demonstrating substantial equivalence to a predicate device through preclinical testing and does not contain information regarding clinical studies, acceptance criteria, or performance metrics in the way typically required for AI/ML device evaluations.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from the given text.

The document primarily covers:

Device Name: Precise™ Nitinol Stent Transhepatic Biliary System (6F)
Predicate Device: Precise™ Nitinol Stent Transhepatic Biliary System (510(k) # K010445)
Classification: Class II
Indications for Use: Palliation of malignant neoplasms in the biliary tree.
Device Description: Stent delivery system profile, stent material, expanded stent diameters, stent lengths, usable length, and guidewire lumen.
Biocompatibility: Stated that all materials are biocompatible.
Substantial Equivalence: Stated that equivalence was confirmed through "pre-clinical testing."

There is no mention of:

Acceptance criteria for device performance.
Any clinical study or performance study on humans or with AI/ML components.
Sample sizes for test sets or training sets.
Data provenance, expert ground truth, adjudication methods, or MRMC studies.
Ground truth types.

Summary

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OCT - 5 2001

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510(k) Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	Precise™ Nitinol Stent TranshepaticBiliary System (6F)	Biliary Stent
Name ofPredicateDevices	The device is substantially equivalent to:• Precise™ Nitinol Stent Transhepatic Biliary System (510(k) # K010445 –May 16, 2001).
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 Precise™ Nitinol Stent Transhepatic Biliary System (6F) is intendedfor use in the palliation of malignant neoplasms in the biliary tree.
DeviceDescription	The device description of the proposed Precise™ Nitinol StentTranshepatic Biliary System (6F) is as follows.• 5 / 6 French stent delivery system profile;• Stent material – Nickel Titanium alloy;• Expanded stent diameters 8, 9, and 10 mm;• Stent lengths: 20, 30, and 40 mm;• Stent delivery system usable length 135 cm; and• Guidewire lumen 0.018".
Biocompatibility	All materials used in the Precise™ Nitinol Stent Transhepatic BiliarySystem (6F) are biocompatible.
Summary ofSubstantialEquivalence	The Precise™ Nitinol Stent Transhepatic Biliary System (6F) issubstantially equivalent to the predicate device. The equivalence wasconfirmed through pre-clinical testing.
Precise™ Nitinol Stent Transhepatic Biliary System (6F)Special 510(k)

Special 510(k)
September 5, 2001

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5 2001 OCT

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sam A. Mirza Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014

Re: K012993

Trade/Device Name: Precise™ Nitinol Stent Transhepatic Biliary System (6F) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: September 5, 2001 Received: September 6, 2001

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.

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

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Page 2 - Mr. Sam Mirza

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): K012993

Device Name: Precise™ Nitinol Stent Transhepatic Biliary System (6F)

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

Precise™ Nitinol Stent Transhepatic Biliary System (6F) is indicated for The use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use_

Colin M. Pollard

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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.