SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K021898 · Cordis Corp. · FGE · Aug 14, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021898
• Device Name: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 14, 2002
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMARTTM ControlTM Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

Self-expanding nitinol stent system for biliary tract; used for palliation of malignant biliary neoplasms. System includes 6 French delivery catheter with proximal deployment handle; stent composed of nickel-titanium alloy with tantalum micromarkers. Available in diameters 6-10 mm and lengths 20-100 mm. Operated by clinicians during interventional procedures to maintain biliary patency. Device is delivered via guidewire (0.035").

Clinical Evidence

Bench testing only.

Technological Characteristics

Nickel-titanium alloy stent with tantalum micromarkers; 6 French delivery system; 0.035" guidewire lumen; self-expanding mechanism; usable lengths 80 and 120 cm; biocompatible materials.

Indications for Use

Indicated for the palliation of malignant neoplasms in the biliary tree.

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 PreciseTM Nitinol Stent Transhepatic Biliary System (6F) (K012993)
• S.M.A.R.T.TM Nitinol Stent and Delivery System (K001843)
• Cordis SAVVYTM PTA Balloon Catheter (K971010)
• Bridge SE Self Expanding Stent Delivery System (K011080)

Submission Summary (Full Text)

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## AUG 1 4 2002

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# 510(k) Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Proprietary Name | Common or Usual Name |
| | SMARTTM ControlTM Nitinol Stent<br>Transhepatic Biliary System | Biliary Stent |
| Name of<br>Predicate<br>Devices | The device is substantially equivalent to:<br>Cordis PreciseTM Nitinol Stent Transhepatic Biliary System (6F) (510(k) #<br>K012993 - October 15, 2001) - Cordis Corporation. S.M.A.R.T.TM Nitinol Stent and Delivery System (Improved Radiopacity)<br>(510(k) # K001843 – July 18, 2000 - Cordis Corporation. Cordis SAVVYTM PTA Balloon Catheter (510(k) # K971010 – June 18,<br>1997) - Cordis Corporation. Bridge SE Self Expanding Stent Delivery System – (510(k) # K011080 –<br>October 11, 2001 - Medtronic AVE Inc. | |
| Classification | Class II. | |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Food, Drug and Cosmetic Act. | |
| Indications<br>for Use | The SMARTTM ControlTM Nitinol Stent Transhepatic Biliary System is<br>intended for use in the palliation of malignant neoplasms in the biliary tree. | |
| Device<br>Description | The device description of the proposed SMARTTM ControlTM Nitinol Stent<br>Transhepatic Biliary System is as follows. 6 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum<br>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 | |

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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 [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 §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 [phone] or [phone] 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