MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K032457 · Cordis Corp. · FGE · Sep 4, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032457
• Device Name: MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Sep 4, 2003
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMART™ Control™ 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 in clinical settings to maintain biliary patency. Device delivered via guidewire (0.035" lumen) to target site; stent expands upon deployment to provide structural support. Benefits include relief of biliary obstruction caused by malignancy.

Clinical Evidence

No clinical data; substantial equivalence supported by pre-clinical bench testing.

Technological Characteristics

Materials: Nickel-titanium alloy (nitinol) stent, tantalum micromarkers. Delivery system: 6 French profile, 80/120 cm usable length, 0.035" guidewire lumen. Deployment: Proximal handle. 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

• SMART™ Control Nitinol Stent Transhepatic Biliary System (K021898)
• SMART™ Control Nitinol Stent Transhepatic Biliary System (K031777)

Submission Summary (Full Text)

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SEP - 4 2003

K032457
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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 |
| | SMART™ Control™ Nitinol Stent<br>Transhepatic Biliary System | Biliary Stent |
| Name of<br>Predicate<br>Devices | The predicate devices are as follows:<br>SMART™ Control Nitinol Stent Transhepatic Biliary System (510(k) # K021898 – August 14, 2002) - Cordis Corporation. SMART™ Control Nitinol Stent Transhepatic Biliary System (510(k) # K031777 – July 07, 2003) - Cordis Corporation. | |
| 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 SMART™ Control™ 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 SMART™ Control™ 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 | |
| Biocompatibility | All materials used in the SMART™ Control™ Nitinol Stent<br>Transhepatic Biliary System are biocompatible. | |

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K032457
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The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is Summary of Substantial substantially equivalent to the predicate devices. The equivalence was Equivalence confirmed through pre-clinical testing.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 2003

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

Re: K032457

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: August 8, 2003 Received: August 11, 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 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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.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): K032457

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

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

The Cordis S.M.A.R.T.TM 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)

OR

Over-the-Counter Use

Nancy C. Brayton

(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number