(60 days)
No
The description focuses on the mechanical components of a stent and delivery system, with no mention of AI or ML.
Yes
The device is indicated for "palliation of malignant neoplasms in the biliary tree," which is a therapeutic purpose.
No
This device is a stent delivery system used for palliation of malignant neoplasms, meaning it is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components including a stent made of 316L stainless steel, a balloon catheter, and a stainless steel introducer tube. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a stent and a delivery system used to treat malignant neoplasms in the biliary tree. This is an implantable medical device used directly within the body for therapeutic purposes (palliation of malignant neoplasms).
- Intended Use: The intended use is to palliate malignant neoplasms in the biliary tree, which is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the provided information, the Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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".
Product codes
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
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.(b)
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.
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