(60 days)
Not Found
Not Found
No
The device description focuses on the mechanical components of a stent and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the palliation of malignant neoplasms in the biliary tree, which is a therapeutic intervention aimed at alleviating symptoms and improving the patient's condition.
No
The device is a stent intended for palliation of malignant neoplasms in the biliary tree, which is a therapeutic rather than diagnostic function.
No
The device description clearly details a physical medical device (stent, balloon catheter, delivery system) made of materials like stainless steel and designed for physical implantation and manipulation within the body. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body to treat a condition.
- Device Description: The device is a stent and a delivery system designed to be implanted in the biliary tree. This is an invasive medical device used for treatment.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve any of these activities.
Therefore, the Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, laser- cut stent made from 316L Stainless Steel tubing. The stent is sold mounted on a Cordis SLALOM percutaneous transluminal angioplasty (PTA) balloon catheter. The stent is provided in nominal, unexpanded stent lengths from 12 – 39 mm. The stent is designed for expansion to diameters from 3 - 8 mm, depending on the diameter of the associated balloon upon which it is mounted with system lengths of 80 cm and 135 cm. The delivery system utilizes an over-the-wire (OTW) dual lumen design and is a PTA balloon catheter with a distal DURALYN™ balloon and a proximal Y-connector. The balloon has two radiopaque markers that aid in stent placement within the stenosis and is designed with a known diameter and length. The Y-connector has an injectate lumen (marked "THRU") that is used to inject contrast medium via hand injection and to track the catheter over a guide wire up to .018". The inflation lumen (marked "BALLOON") is used to inflate and deflate the balloon with a contrast medium/saline mixture. The nominal balloon size and length is printed on the Y-connector. A metal introducer tube is included in the packaging. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile (via ethylene oxide) and is intended for single use only
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System has been demonstrated via data collected from non-clinical design verification tests and analyses. As the materials did not change, the materials used are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 .018 SLALOM Delivery System
Cordis Europa, N.V., a Johnson & Johnson Company
510(k) Premarket Notific
Attachment 1
ದ
510 (k) Summary
| Submitter's name and address | Cordis Europa, NV Oosteinde 8 NL-9301 LJ Roden The Netherlands |
|---|---|
| Contact Person | Harm Hovinga Senior Regulatory Affairs Associate Tel: +31 - (5050) 22479 Fax: +31 - (5050) 22456 e-mail: hhovinga@crdnl.jnj.com |
| Date prepared | April 26, 2002. |
| Device Trade Name | Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System. |
| Common Name | Biliary stent and accessories |
| Classification Name | FGE (21 CFR 876.5010 Biliary Catheter.) |
| Device Classification | Class II. |
| Performance standards | Performance standards have not been established for this device by the FDA under section 514 of the Food, Drug and Cosmetic Act. |
1
,
--
. /
| Product Description | The PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, laser- cut stent made from 316L Stainless Steel tubing. The stent is sold mounted on a Cordis SLALOM percutaneous transluminal angioplasty (PTA) balloon catheter. The stent is provided in nominal, unexpanded stent lengths from 12 – 39 mm. The stent is designed for expansion to diameters from 3 - 8 mm, depending on the diameter of the associated balloon upon which it is mounted with system lengths of 80 cm and 135 cm. The delivery system utilizes an over-the-wire (OTW) dual lumen design and is a PTA balloon catheter with a distal DURALYN™ balloon and a proximal Y-connector. The balloon has two radiopaque markers that aid in stent placement within the stenosis and is designed with a known diameter and length. The Y-connector has an injectate lumen (marked "THRU") that is used to inject contrast medium via hand injection and to track the catheter over a guide wire up to .018". The inflation lumen (marked "BALLOON") is used to inflate and deflate the balloon with a contrast medium/saline mixture. The nominal balloon size and length is printed on the Y-connector. A metal introducer tube is included in the packaging. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile (via ethylene oxide) and is intended for single use only |
|---|---|
| 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. |
| Technological comparison | Comparisons of the subject and predicate device shows that technological characteristics, such as materials, mode of operation, performance properties, biocompatibility, sterilization and packaging are substantially equivalent to the currently marketed predicate device, which bears the same Tradename "PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System". |
| Performance Data | The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System has been demonstrated via data collected from non-clinical design verification tests and analyses. As the materials did not change, the materials used are biocompatible. |
2
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 FDA 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 pre-market approval or reclassification. The determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2002
Cordis Europa, N.V. c/o Ms. Karen Wilk Manager, Regulatory Affairs Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059
K021345 Re:
Trade/Device Name: PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: May 31, 2002 Received: June 3, 2002
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.
4
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 (QS) 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.
Bernard E. Statland. M.D., Ph.D. 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): K021345
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" Delivery System is intended for the palliation of malignant neoplasms in the biliary tree.
Prescription Use V . OR (Per 21 CFR 801.109)
Over-The-Counter Use
Otrist C. Siggman