CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM

K012056 · Cordis Europa, N.V. · FGE · Aug 1, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012056
• Device Name: CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
• Applicant: Cordis Europa, N.V.
• 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 on SLALOM .018" Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

Balloon-expandable, stainless steel stent premounted on SLALOM .018" balloon catheter; used for palliation of malignant neoplasms in biliary tree. Stent available in 12, 15, 18, and 24 mm lengths; expandable to 3-6 mm diameters. Operated by physician in clinical setting. Stent deployed via balloon inflation to maintain biliary patency; provides mechanical support to biliary duct. Single-use, sterile device.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated via non-clinical design verification tests and analyses. Biocompatibility of all materials confirmed.

Technological Characteristics

Balloon-expandable stainless steel stent; premounted on SLALOM .018" balloon catheter. Stent lengths: 12, 15, 18, 24 mm; expansion diameter: 3-6 mm. Sterile, single-use. No software or electronic components.

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 BX Transhepatic Biliary Stent and Delivery System (K001258)
• Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent and Delivery System (K992755 and K994156)
• Cordis SLALOM PTA Balloon Catheter (K003159)

Submission Summary (Full Text)

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Cordis Europa N.V. , a Johnson & Johnson company Special 510(k) Premarket Notification

Attachment 1

KO12056

## Summary of Safety and Effectiveness

| Submitter: | Harm Hovinga<br>Regulatory Affairs Associate<br>Cordis Europa, N.V.<br>Oosteinde 8<br>NL-9301 LJ Roden<br>The Netherlands<br>Tel: +31 - (5050) 22479<br>Fax: +31 - (5050) 22456<br>e-mail: <a href="mailto:[e-mail]">[e-mail]</a> |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Chuck Ryan<br>Manager, Regulatory Affairs<br>Cordis Corporation<br>7 Powder Horn Drive<br>Warren, New Jersey 07059<br>USA<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: <a href="mailto:[e-mail]">[e-mail]</a> |
| Date prepared | 29 June 2001. |
| General provisions | |
| | Trade name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System. |
| | Common Name: Biliary stent and accessories |
| | Classification Name: 21 CFR 876.5010 Biliary Catheter. |
| Device Classification | Class II. |
| Name of predicate device(s) | ➤ Cordis BX Transhepatic Biliary Stent and Delivery System (reference K001258)<br>➤ Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent and Delivery System (ref. K992755 and K994156)<br>➤ Cordis SLALOM PTA Balloon Catheter (ref. K003159) |

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Cordis Europa N.V. , a Johnson & Johnson company Special 510(k) Premarket Notification

| Performance<br>standards | Performance standards have not been established for this device by the FDA under<br>section 514 of the Food, Drug and Cosmetic Act. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery<br>System is a balloon-expandable, stainless steel stent that is provided premounted<br>upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in<br>four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed<br>for expansion to diameters from 3 to 6 mm, depending on the diameter of the<br>associated balloon upon which it is mounted.<br><br>The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery<br>System is provided sterile and is intended for single use only. |
| Intended Use | The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018"<br>Delivery System is intended for use in the palliation of malignant neoplasms in the<br>biliary tree. |
| Performance<br>Data | The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary<br>Stent on SLALOM .018" Delivery System has been demonstrated via data collected<br>from non-clinical design verification tests and analyses. |
| Biocompati-<br>bility | All materials used in the PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM<br>.018" Delivery System are biocompatible. |
| | A statement of substantial equivalence to another product is required by 21<br>CFR 807.87 and relates only to whether the present product can be marketed<br>without prior reclassification or clinical approval. The present submission is<br>therefore not related to the coverage of any patent and is not to be interpreted<br>as an admission or used as evidence in a patent infringement lawsuit. As the<br>commissioner of the FDA stated: "A determination of substantial equivalence<br>under the Fedral Food, Drug and Cosmetic Act releted to the fact that the<br>product can be lawfully marketed without pre-market approval or<br>reclassification. The determination is not intended to have any bearing<br>whatsoever on the resolution of patent infringement suits." 42 Federal Register<br>42, 50 et seq. (1977). |

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the three branches of government. The logo is surrounded by a circle of text that reads "U.S. Department of Health & Human Services - USA."

AUG 0 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cordis Europa, N.V. c/o Mr. Chuck Ryan, RAC Manager, Regulatory Affairs Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059

Re: K012056

> Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: June 29, 2001 Received: July 2, 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 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. Chuck Ryan, RAC

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". ﻬﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Sincerely yours,

Bernard E. Statland, M.D., Ph.D.

Director Office of Device Evaluation Center for Devices and Radiological Health

: 2

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510(k) Number (if known): K012056

Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System

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

The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" The Court I ALTH LS & Sor the palliation of malignant neoplasms in the biliary tree.

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

David C. Symons
(Division Sign-Off)

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