SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K020052 · Cordis Corp. · FGE · Feb 11, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020052
• Device Name: SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Feb 11, 2002
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System is a self-expanding stent delivery system designed for biliary applications. The device consists of a nickel-titanium (Nitinol) alloy stent with tantalum radiopaque markers, mounted on a 7 French delivery system. It is used by clinicians to provide palliation for malignant neoplasms within the biliary tree. The stent is deployed via a 0.035" guidewire lumen. The system is available in various diameters (6-10 mm) and lengths (20-80 mm) with a 40 cm usable delivery length. The device is intended for biliary use only; safety and effectiveness for vascular use have not been established.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Nickel-Titanium alloy stent, tantalum radiopaque markers. Delivery system: 7 French profile, 40 cm usable length, 0.035" guidewire lumen. Stent diameters: 6, 7, 8, 9, 10 mm. Stent lengths: 20, 40, 60, 80 mm. Biocompatible materials.

Indications for Use

Indicated for the palliation of malignant neoplasms in the biliary tree in patients requiring biliary stenting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cordis SMART™ Nitinol Stent Transhepatic Biliary System (K001843)

Submission Summary (Full Text)

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2-11-02 510(k) Summary of Safety and Effectiveness 020052 The name of the device is: General Provisions Common or Usual Name Proprietary Name Biliary Stent Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm The device is substantially equivalent to: Name of Cordis SMART™ Nitinol Stent Transhepatic Biliary System (510(k) # Predicate ● K001843 - July 18, 2000). Devices Class II. Classification Performance standards have not been established by the FDA under section Performance 514 of the Food, Drug and Cosmetic Act. Standards The Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm Indications is intended for use in the palliation of malignant neoplasms in the biliary tree. for Use The device description of the proposed Cordis SMART™ Nitinol Stent Device Transhepatic Biliary System - 40 cm is as follows. Description 7 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, 40, 60, and 80 mm; ● Stent delivery system usable length 40 cm; and . Guidewire lumen 0.035". . All materials used in the Cordis SMART™ Nitinol Stent Transhepatic Biocompatibility Biliary System - 40 cm are biocompatible. The Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm Summary of is substantially equivalent to the predicate device. The equivalence was Substantial Equivalence confirmed through pre-clinical testing. SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm Special 510(k) January 4, 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

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

Re: K020052

Trade/Device Name: Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic

Biliary System - 40 cm Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: January 4, 2002 Received: January 8, 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 (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 your 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 (QS) 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 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Bernard land, 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): K020052

Device Name: Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm

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

The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm is intended for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use OR
(Per 21 CFR 801.109)

Over-The-Counter Use

Nancy C brogdon

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