← Product Code [FGE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE) · K033394 # CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM (K033394) _Cordis Corp. · FGE · Dec 22, 2003 · Gastroenterology, Urology · SESU_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K033394 ## Device Facts - **Applicant:** Cordis Corp. - **Product Code:** [FGE](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE.md) - **Decision Date:** Dec 22, 2003 - **Decision:** SESU - **Submission Type:** Special - **Regulation:** 21 CFR 876.5010 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree. ## Device Story The PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, laser-cut 316L stainless steel stent mounted on an OPTA PRO balloon catheter delivery system. It is used by physicians in a clinical setting to treat malignant neoplasms in the biliary tree. The device is delivered to the site via the catheter; the balloon is inflated to expand the stent to a diameter of 4mm to 10mm, providing structural support to the biliary duct. This palliation helps maintain biliary patency. The delivery system includes a 304 stainless steel introducer tube. The device is a line extension of a previously cleared system, maintaining the same fundamental scientific technology. ## Clinical Evidence Bench testing only. Safety and effectiveness were demonstrated through non-clinical design verification tests and analyses. All materials were tested for biocompatibility per ISO-10993, Part 1. ## Technological Characteristics Stent: 316L stainless steel (ASTM F138), laser-cut, balloon-expandable. Delivery system: OPTA PRO PTA balloon catheter. Accessory: 304 stainless steel introducer tube. Stent lengths: 12mm to 79mm. Expansion diameters: 4mm to 10mm. Biocompatibility: ISO-10993 compliant. ## Regulatory 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 GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System ([K012590](/device/K012590.md)) ## Reference Devices - OPTA PRO PTA balloon catheter ([K032737](/device/K032737.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO Delivery System Cordis Corporation, a Johnson & Johnson Company 510(k) Premarket Notification ## Attachment 1 Ko3394 ## Summary of Safety and Effectiveness | Submitter &
Contact
person: | Cordis Europa, N.V., a Johnson & Johnson Company
Harm Hovinga
Senior Regulatory Affairs Associate
Oosteinde 8
NL-9301 LJ Roden,
The Netherlands
Tel .: (+31) (5050) 22479
Fax: (+31) (5050)-22456
e-mail: hhovinga@crdnl.jnj.com | |------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared | October 22, 2003 | | Trade Name | Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"
Delivery System. | | Classification
Name &
Device
Classification | Common Name: Biliary Stent and accessories
Classification Name: 21 CFR 876.5010: Biliary Catheter and Accessories.
Class II; Product Code: 78FGE. | | Device
description | The PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"
Delivery System represents a line extension to the original Cordis premounted
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"
Delivery System (ref. 510(k) #K012590) with no change to the indication for
use or to the fundamental scientific technology of the predecessor device.
Stent:
The PALMAZ GENESIS Transhepatic Biliary stent is a balloon expandable,
laser cut stent mounted on a Cordis balloon catheter (OPTA PRO) and is
currently provided in ten (10) nominal unexpanded stent lengths from 12mm
to 79 mm. The stent is designed for expansion to diameters from 4mm to 10
mm, depending on the diameter of the associated balloon upon which it is
mounted. | {1}------------------------------------------------ 510(k) Premarket Notification ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | The PALMAZ Genesis stent is laser cut from a 316L stainless steel tube that
meets the chemical analysis requirements of American Society for Testing
Materials (ASTM) standard F138. | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Delivery system:
The delivery system features the same OPTA PRO PTA balloon catheter,
which was recently cleared by FDA via 510(k) #K032737, determined
substantially equivalent on October 02, 2003), which incorporated this
modified hub.
Accessory: | | | The delivery system features the same accessory (a 304 stainless steel
Introducer Tube), which is packaged in the device packaging. | | Intended Use | The Intended Use has not changed and remains as
"The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO
.035" Delivery System is indicated for use in the palliation of malignant
neoplasms in the biliary tree". | | Name of
affected
device | Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"
Delivery System. | | Performance
standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not
established performance standards for these devices. | | Safety and
Performance
Data | The safety and effectiveness of the affected balloon expandable stent and
delivery system has been demonstrated via data collected from non-clinical
design verification tests and analyses. All materials used in this modified
device have been tested according to ISO-10993, Part 1 and were found
biocompatible. | | Conclusion | The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO
.035" Delivery System is substantially equivalent to the predicate original
device. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping waves or curves, possibly representing the flow of health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 2 2003 Ms. Karen Wilk Regulatory Affairs Manager Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059 Re: K033394 > Trade/Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 24, 2003 Received: November 25, 2003 Dear Ms. Wilk. 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. {3}------------------------------------------------ Page 2 - Ms. Karen Wilk 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 (OS) 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 (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html. Sincerely yours, Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K033394 Device Name: _Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System FDA's Statement of the Indications For Use for device: The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree. Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109) vision of Reproductive. and Radiological Devi- 510(k) Number K033394 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K033394](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGE/K033394) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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