PALMAZ XL TANSHEPATIC BILIARY STENTS

K993091 · Cordis Corp. · FGE · Oct 29, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993091
• Device Name: PALMAZ XL TANSHEPATIC BILIARY STENTS
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Oct 29, 1999
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Cordis PALMAZ® XL Transhepatic Biliary Stents are intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The Cordis PALMAZ® XL Transhepatic Biliary Stent is a balloon-expandable, laser-cut stent manufactured from 316L stainless steel. It is supplied unmounted in 40 mm and 50 mm lengths, designed to expand to a 10 mm diameter. The device is intended for use in the biliary tree to provide palliation for malignant neoplasms. It is deployed using a Cordis POWERFLEX™ PLUS Percutaneous Transluminal Angioplasty (PTA) balloon catheter. The device is intended for prescription use by clinicians. Safety and effectiveness for use in the vascular system have not been established.

Clinical Evidence

Bench testing only.

Technological Characteristics

Balloon-expandable, laser-cut stent; material: 316L stainless steel; lengths: 40 mm and 50 mm; expansion diameter: 10 mm; supplied unmounted for use with PTA balloon catheter; biocompatible materials.

Indications for Use

Indicated for patients requiring 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 PALMAZ® Balloon Expandable Transhepatic Biliary Stents

Submission Summary (Full Text)

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## OCT 2 9 1999

## Attachment 4

.. * --、

## Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Proprietary Name | Common or Usual Name |
| | Cordis PALMAZ® XL Transhepatic Biliary<br>Stents | Biliary Stent |
| Name of<br>Predicate<br>Devices | The device is substantially equivalent to:<br>• Cordis PALMAZ® Balloon Expandable Transhepatic Biliary Stents | |
| 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 for<br>Use | The Cordis PALMAZ® XL Transhepatic Biliary Stents are intended for use<br>in the palliation of malignant neoplasms in the biliary tree. | |
| Device<br>Description | The PALMAZ® XL Transhepatic Biliary Stent is a balloon-expandable,<br>laser cut stent made from 316L stainless steel tubing.<br>The stent is<br>supplied in two nominal lengths: 40 mm, and 50 mm. The stent is<br>designed to expand to 10mm diameter.<br>The PALMAZ® XL<br>Transhepatic Biliary Stent is sold unmounted for use with the Cordis<br>POWERFLEX™ PLUS Percutaneous Transluminal Angioplasty (PTA)<br>balloon catheter. | |
| Biocompatibility | All materials used in the Cordis PALMAZ® XL Transhepatic Biliary Stents<br>are biocompatible. | |

Cordis PALMAZ™ XL Transhepatic Biliary Stent Special 510(k) September, 1999

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The Cordis PALMAZ® XL Transhcpatic Biliary Stents are substantially Summary of equivalent to the predicate device. The equivalence was confirmed through Substantial Equivalence pre-clinical testing.

Cordis PALMAZ™ XL Transhepatic Biliary Stent Special 510(k) September, 1999

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of several curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1999

Ms. Ariel MacTavish, RAC Manager, Regulatory Affairs Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700

Re: K993091 Cordis PALMAZ® XL Transhepatic Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: October 14, 1999 Received: October 15, 1999

Dear Ms. MacTavish:

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 In incels in the start comments, 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, includes proximity to the trade name, of a similar point size, and other proniot

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Page 2 - Ms. Ariel MacTavish

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 a 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]. Aller please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) Other general information on your responsibilities under the Academi 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,

Kimber C. Richter for

David W. Feigal, Jr., M.D., M.P.H. Acting 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): K993091

Device Name: _Cordis PALMAZ® XL Transhepatic Biliary Stent____________________________________________________________________________________________________________________

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

The Cordis PALMAZ® XL Transhepatic Biliary Stent 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__________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K993091/5 |
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