PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K032137 · Cordis Corp. · FGE · Sep 17, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032137
• Device Name: PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Sep 17, 2003
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The Precise™ Rx Nitinol Stent Transhepatic Biliary System is a self-expanding nitinol stent designed for biliary applications. The device is delivered to the lesion site via a Rapid Exchange (Rx) delivery system compatible with 0.014" guidewires. The delivery system features a 5 F profile for 5-7 mm diameter stents and a 6 F profile for 8-10 mm diameter stents. Stent lengths range from 20 to 40 mm. The device is intended for use by clinicians in a clinical setting to provide palliative relief for malignant biliary obstructions. The stent is deployed to maintain patency in the biliary tree, potentially improving patient quality of life by alleviating symptoms associated with malignant neoplasms. The device is not indicated for vascular use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitinol stent; Rapid Exchange (Rx) delivery system; 5 F (5-7 mm diameter) or 6 F (8-10 mm diameter) delivery profile; 0.014" guidewire compatibility; 135 mm usable length; 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 Precise™ Nitinol Stent Transhepatic Biliary System (K012993)
• Cordis Precise™ Nitinol Stent Transhepatic Biliary System (K010445)
• Cordis SMART Control Nitinol Stent Transhepatic Biliary System (K021898)
• Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery system (K012822)
• Bard LUMINEXX™ 6 Fr Biliary Stent and Delivery System (K020682)

Submission Summary (Full Text)

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# SEP 1 7 2003

K032137
page 1 of 2

# 510(k) Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Proprietary Name | Common or Usual Name |
| | Precise™ Nitinol Stent Transhepatic<br>Biliary System | Biliary Stent |
| Name of<br>Predicate<br>Devices | The predicate devices are as follows:<br>Cordis Precise™ Nitinol Stent Transhepatic Biliary System<br>System (510(k) # K012993 – October 5, 2001) - Cordis Corporation. Precise™ Nitinol Stent Transhepatic Biliary System<br>(510(k) # K010445 - March 16, 2001) Cordis Corporation. SMART Control Nitinol Stent Transhepatic Biliary System (510(k) #<br>K021898 - August 14, 2002) - Cordis Corporation. Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail<br>Delivery system (510(k) # K012822 – October 24, 2001) – Boston<br>Scientific Corporation. Bard LUMINEXX™ 6 Fr Biliary Stent and Delivery System (510(k) #<br>K020682 - April 02, 2002) - C.R. Bard 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 proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System is<br>intended for use in the palliation of malignant neoplasms in the biliary tree. | |

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K032137
Page 2 of

Device
Description
The device description of the proposed Precise™ Rx Nitinol Stent
Transhepatic Biliary System is as follows.

- Delivery system profile in the area of stent housing is 5 F for stent diameters ranging from 5-7 mm and 6F for stent diameters ranging from 8-10 mm.
- The stent will be delivered to the lesion site via the Rapid Exchange Stent Delivery System
- Guidewire Lumen - 0.014"
- Stent delivery system useable length - 135 mm
- Stent lengths - 20, 30 and 40 mm
- Stent diameters - 5, 6, 7, 8, 9, and 10 mm

Biocompatibility
All materials used in the proposed Precise™ Rx Nitinol Stent
Transhepatic Biliary System are biocompatible.

The proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System is Summary of substantially equivalent to the predicate devices. The equivalence was Substantial 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20050

### SEP 1 7 2003

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

Re: K032137

Trade/Device Name: Cordis Precise™ Rx 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 14, 2003 Received: August 18, 2003

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 yours,

Daniel G. Schultz, M.D.

Director Office of Device Evaluation Center for Devices and Radiological Health

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#### Page _ 1 of 1

510(k) Number (if known): K032137

Device Name: Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System

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

The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Daniel h. Lyman
(Division Sign-Off)

(Division Sign-Off) Division of Reproductiv and Radiological De 510(k) Number