(43 days)
Cordis PALMAZ® Balloon Expandable Transhepatic Biliary Stents
Not Found
No
The summary describes a physical medical device (a stent) and its intended use, without any mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
Explanation: The device is intended for the palliation of malignant neoplasms in the biliary tree, which is a therapeutic purpose.
No
The device is a stent used for palliation of malignant neoplasms, which is a treatment, not a diagnosis.
No
The device description clearly states it is a physical stent made from stainless steel tubing, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Cordis PALMAZ® XL Transhepatic Biliary Stent is a physical implantable device (a stent) designed to be placed inside the body (in the biliary tree) to open up blockages.
- Intended Use: The intended use is to palliate malignant neoplasms in the biliary tree, which is a therapeutic intervention performed in vivo.
The description clearly indicates a device used for a therapeutic procedure performed within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Cordis PALMAZ® XL Transhepatic Biliary Stents are intended for use in the palliation of malignant neoplasms in the biliary tree.
Product codes
78 FGE
Device Description
The PALMAZ® XL Transhepatic Biliary Stent is a balloon-expandable, laser cut stent made from 316L stainless steel tubing. The stent is supplied in two nominal lengths: 40 mm, and 50 mm. The stent is designed to expand to 10mm diameter. The PALMAZ® XL Transhepatic Biliary Stent is sold unmounted for use with the Cordis POWERFLEX™ PLUS Percutaneous Transluminal Angioplasty (PTA) balloon catheter.
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 equivalence was confirmed through pre-clinical testing.
Key Metrics
Not Found
Predicate Device(s)
Cordis PALMAZ® Balloon Expandable Transhepatic Biliary Stents
Reference Device(s)
Not Found
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.
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OCT 2 9 1999
Attachment 4
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Summary of Safety and Effectiveness
| General
| Provisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Cordis PALMAZ® XL Transhepatic Biliary | ||
| Stents | Biliary Stent | |
| Name of | ||
| Predicate | ||
| Devices | The device is substantially equivalent to: | |
| • Cordis PALMAZ® Balloon Expandable Transhepatic Biliary Stents | ||
| Classification | Class II. | |
| Performance | ||
| Standards | Performance standards have not been established by the FDA under section | |
| 514 of the Food, Drug and Cosmetic Act. | ||
| 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 | ||
| Description | The PALMAZ® XL Transhepatic Biliary Stent is a balloon-expandable, | |
| laser cut stent made from 316L stainless steel tubing. | ||
| The stent is | ||
| supplied in two nominal lengths: 40 mm, and 50 mm. The stent is | ||
| designed to expand to 10mm diameter. | ||
| The PALMAZ® XL | ||
| Transhepatic Biliary Stent is sold unmounted for use with the Cordis | ||
| POWERFLEX™ PLUS Percutaneous Transluminal Angioplasty (PTA) | ||
| balloon catheter. | ||
| Biocompatibility | All materials used in the Cordis PALMAZ® XL Transhepatic Biliary Stents | |
| are biocompatible. |
Cordis PALMAZ™ XL Transhepatic Biliary Stent Special 510(k) September, 1999
1
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
2
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 (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 |
|---|---|
| --------------- | ----------- |