CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT

K012087 · Cordis Corp. · FGE · Aug 1, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012087
• Device Name: CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 1, 2001
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.

Device Story

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent designed for biliary applications. It is provided unmounted and sterile. In a clinical setting, a physician hand-crimps the stent onto a recommended balloon catheter (e.g., Cordis OPTA PRO). The assembly is advanced over a guidewire through a sheath lumen to the biliary obstruction site using a metal introducer tube. The balloon is inflated to expand the stent, then deflated and removed, leaving the stent in place to maintain patency. The device is intended for single use. It provides mechanical support to palliate malignant biliary obstructions. The device is not indicated for vascular use.

Clinical Evidence

Bench testing only. Safety and effectiveness were demonstrated via non-clinical design verification tests and analyses.

Technological Characteristics

Balloon-expandable stainless steel stent. Nominal unexpanded lengths 12-24 mm; expanded diameters 5-8 mm. Sterilized via gamma irradiation. Single-use. Mechanical deployment via balloon catheter.

Indications for Use

Indicated for palliation of malignant neoplasms in the biliary tree. Not for use in the vascular system.

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 BX Transhepatic Biliary Stent and Delivery System (K001258)
• Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stents (K992755)
• Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stents (K994156)

Submission Summary (Full Text)

{0}------------------------------------------------

KOI 2087

# 210(k) Summary of Safety and Effectiveness

| Submitter: | Cordis Corporation, a Johnson & Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059 | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | Telephone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Chuck Ryan, RAC<br>Manager, Regulatory Affairs<br>Cordis Corporation, a Johnson & Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059 | Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 2, 2001 | |
| Trade Name: | Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent | |
| Common Name: | Biliary Stent and Accessories | |
| Classification Name: | Biliary Catheter and Accessories (per 21 CFR 876.5010) | |
| Device Classification: | Class II | |

## Summary of Substantial Equivalence:

The design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ GENESIS Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258). In short, the subject Cordis PALMAZ GENESIS Transhepatic Biliary Stent represents an unmounted (provided separately from its delivery catheter) line extension to this predecessor device.

{1}------------------------------------------------

### Device Description:

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is hand crimped upon its recommended balloon catheter delivery device. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and removed.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.

#### Intended Use:

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.

### Technological Characteristics:

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent incorporates a design, size range, method of deployment, device and packaging materials, fundamental technology, delivery devices, intended use, and manufacturing and sterilization processes substantially equivalent to those featured among the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258) and Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stents (see 510(k)s #K992755 and K994156). The PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 12-24 mm and is designed for expanded diameters of 5-8 mm.

#### Performance Data:

The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses.

A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the stated, "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Bockville MD 20850

AUG 0 1 2001

Mr. Chuck Ryan, RAC Manager, Regulatory Affairs Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059

K012087 Re:

Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent (12-24 mm Lengths) Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 2, 2001 Received: July 3, 2001

Dear Mr. Ryan:

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 atore 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.

{3}------------------------------------------------

# Page 2 - Mr. Chuck Ryan, RAC

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see acchiect to such additional controls. Existing major regulations (Premarket Apployal), it may of sacree of Federal Regulations, Title 21, Parts 800 to 895. affecting your do rive can determination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS Medical Devices. General regalation (FDA) will verify such assumptions. Failure to inspections, the Food and Drag Framilias in tegulatory action. In addition, FDA may publish Comply with the GMT regaranting 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 The IDA in a classification for your device and permits your device to proceed to the market. This resuris in a clussified.com rour 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. I herefore, 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 If you desire specific images as a onaly 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, advertising or your de ison 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

{4}------------------------------------------------

510(k) Number (if known): K012087

Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent (12-24 mm Lengths)

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

The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.

Prescription Use OR
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David G. Segura

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