(124 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a stent and delivery system, with no mention of AI or ML.
Yes
The device is a stent system used for the palliation of malignant neoplasms by expanding the biliary tree, which is a therapeutic intervention.
No
This device is a stent system used for the palliation of malignant neoplasms in the biliary tree, which is a treatment (therapeutic) function, not a diagnostic one.
No
The device description clearly describes a physical medical device (stent, balloon catheter, introducer tube) and its mechanical function (expansion via balloon inflation). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System is a therapeutic device. It is implanted directly into the biliary tree to physically open up blockages caused by malignant neoplasms. It does not analyze or test any bodily fluids or tissues.
- Intended Use: The intended use is "palliation of malignant neoplasms in the biliary tree," which is a treatment, not a diagnostic process.
The description clearly outlines a device that is physically placed within the body to treat a condition, which is the hallmark of a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The PALMAZ BLUE Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis SLALOM 0.18" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz BLUE .018 Transhepatic Biliary Stent System) to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and subsequently the delivery system is removed. The Cordis PALMAZ BLUE .018 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) 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 device and the substantial equivalence to the predicate devices have been demonstrated via data collected from non-clinical in-vitro and animal testing (stent placement in biliary duct) which was prescribed in the FDA's – Guidance for the content of premarket notifications for metal expandable biliary stents. February 5, 1998. The Cobalt Chromium based stent material has been tested according to the ISO10993 part 1 and were concluded 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.
K021345, K012056, K901406, K925072, K933304
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
June 11, 2004
JUN 2 1 2004
K040413
Page 1 of 3
510(k) Summary of Safety and Effectiveness
Submitter
Cordis Europa N.V., Oosteinde 8 9301 LJ Roden The Netherlands
FDA Establishment Registration Number 9610978
| Contact | Bert Roossien, Ph.D.
Manager, Regulatory Affairs
Cordis Europa N.V.
Oosteinde 8
9301 LJ Roden
The Netherlands | Tel: | +31 50 50 22 32 |
|----------|------------------------------------------------------------------------------------------------------------------------------|------|--------------------------------|
| Persons: | | Fax: | +31 50 50 22 45 |
| | | | e-mail: broossie@crdnl.jnj.com |
alternate contact person
| Karen Wilk | Tel: | (908) 412 7257 |
|---|---|---|
| Manager, Regulatory Affairs | Fax: | (908) 412 3915 |
| Cordis Corporation | e-mail: | kwilk@crdus.jnj.com |
| 7 Powderhorn Drive | ||
| Warren, New Jersey 07059 | ||
| USA |
June 11, 2004 Date Prepared:
Device Name and Classification
| Trade Name: | Cordis Palmaz® BLUETM .018 Transhepatic Biliary Stent System |
|---|---|
| Common Name: | Biliary Stent (incl. Accessories) |
| Classification Name: | 21 CFR 876.5010 - Biliary Catheter |
| Device Classification: | Class II |
| FDA Classification Panel: | Gastro-enterology |
| Product Code: | FGE |
1
June 11, 2004
K040413
Page 2 of 3
Performance Standards / Special Controls
There are no performance standards applicable under section 514 of the Food, Drug, and Cosmetic Act for this device.
The contents of this 510(k) premarket notification have been prepared based upon the FDA's -Guidance for the content of premarket notifications for metal expandable biliary stents. February ર્. 1998
Intended Use
The Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.
Product Description
The PALMAZ BLUE Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis SLALOM 0.18" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz BLUE .018 Transhepatic Biliary Stent System) to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and subsequently the delivery system is removed. The Cordis PALMAZ BLUE .018 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.
Summary of Studies
The safety and effectiveness of the device and the substantial equivalence to the predicate devices have been demonstrated via data collected from non-clinical in-vitro and animal testing (stent placement in biliary duct) which was prescribed in the FDA's – Guidance for the content of premarket notifications for metal expandable biliary stents. February 5, 1998. The Cobalt Chromium based stent material has been tested according to the ISO10993 part 1 and were concluded biocompatible.
Summary of Substantial Equivalency
The intended use, components, dimensions (size range), accessories, method of delivery, fundamental technology (operating principle), packaging configuration and packaging materials, manufacturing and sterilization processes featured with the Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System are substantially equivalent to those featured with the predecessor Cordis PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System. With respect to the stent material (Cobalt Chromium-alloy), substantially equivalence is claimed to the De Puy Anatomic Modular Knee (AMK) Posterior Stabilized
2
Image /page/2/Picture/2 description: The image shows handwritten text on a white background. The text at the top reads "K0404B", and below it, the text reads "Page 3 of 3". The handwriting appears to be in black ink and has a casual, cursive style.
Predicate Devices
The following table provides information on the predicate devices.
| Device | Company | 510k # | Concur Date | Substantial Equivalence |
|---|---|---|---|---|
| PALMAZ GENESIS | ||||
| Transhepatic Biliary | ||||
| Stent on SLALOM | ||||
| .018" Delivery | ||||
| System | Cordis Europa, N.V. (part | |||
| of Cordis Corporation) | K021345 | 28 Jun 2002 | Same intended use | |
| Same stent delivery system | ||||
| Same operating principle | ||||
| Same stent dimensions (diameters | ||||
| & lengths) | ||||
| PALMAZ GENESIS | ||||
| Transhepatic Biliary | ||||
| Stent on SLALOM | ||||
| .018" Delivery | ||||
| System | Cordis Europa,N.V. (part | |||
| of Cordis Corporation) | K012056 | 1 Aug 2001 | Same accessory | |
| Same shelf life | ||||
| Same packaging materials | ||||
| Same manufacturing processes | ||||
| Same sterilization process | ||||
| Same sterilization assurance level | ||||
| of 10-6 | ||||
| Anatomic Modular | ||||
| Knee (AMK) | ||||
| Posterior stabilized | De Puy Inc. (a Johnson | |||
| & Johnson company) | K901406 | 23 July 1990 | Same material, i.e. (L605) Cobalt- | |
| Chromium-alloy (conform ASTM | ||||
| F90) used for stabilizing post of | ||||
| the knee system (implant) | ||||
| Anatomic Modular | ||||
| Knee (AMK) | ||||
| Landmark Revision | ||||
| Knee | De Puy Inc. (a Johnson | |||
| & Johnson company) | K925072 | 21 Jan 1994 | ||
| Anatomic Modular | ||||
| Knee (AMK) | ||||
| Posterior Stabilized | De Puy Inc. (a Johnson | |||
| & Johnson company) | K933304 | 30 August | ||
| 1993 |
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2004
Albert Roossien, Ph.D. Manager, Regulatory Affairs Manager, Roga N.V., a Johnson & Johnson Company Oosteinde 8 9301 LJ Roden THE NETHERLANDS
Re: K040413
K.040413
Trade/Device Name: Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 11, 2004 Received: June 14, 2004
Dear Dr. Roossien:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we have revewed your section 510(x) promantee is substantially equivalent (for the indications for referenced above and nave decemined the devices marketed in interstate commence
use stated in the enclosure) to legally marketed predicate marketed in the series that use stated in the enclosure) to legally maneted presentation in the managed Commond Commond Commond Commond Commond prior in May 26, 1970, the chaomistic and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the provisions of the general controls provisions of the Act (Act). You may, mercefore, market the be general controls provisions of the Act include Act and the limitations described below. The general someon proctice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that his device and acceld agas I he Office of Device Evaluation has deterfied in the proposed labeling and that such use could cause will be used for an intended use not tuentified in use proper 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 cstablished.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including Furnermore, the murcation for ontary ase mass e, and other promotional materials, in close pouch, 00%, and carter label of a similar point size, and in bold print.
4
Page 2 - Albert Roossien, Ph.D.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more replations affecting your device can be found may be subject to additional controls. LAIsting major regardens and thing film may publish further
in the Code of Federal Regulations, Title 2 in Print Books . In addition, In the Couc of I cachar Regarating your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA 's issuance of a substanting with other requirements of the Act or any
FDA has made a determination that your device complies. You must comply with FDA has made a determination that your device oversies. You must comply with all
Federal statutes and regulations administered by other Federations (21 CER Part 807): Federal statures and regulations administerou 05 car registration and listing (21 CFR Part 807); the Act's requirements, including, but not mained on the requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing the collection is product rad labeling (21 CFR Part 801), good manufacturing production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic pro systems (QS) regulation (21-54-14-14-14-14-14-14-14-14-10-1050.
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 The FDA Inding of substantial equivatelies or your device to proceed to the market. This results in a classification for your device as described in your Section 510(k) premarket
letter will allow you to begin marketing your device as described in your lebeling notification if the limitation statement described above is added to your labeling.
Please note that the above labeling limitations are required by Section 5 3 (i)(()()() of the Act. Please note that the above labeling innitations are required by a virus ( ( ) ( ) ( ) ( ) ( ) ( ) ( ) ) ) ( ) ( ) ) from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device note If you desire specific information about the applicance at (301) 594-4616. Also, please note (21 CFR Part 801), please contact the Office of Comphanes to offication' (21 CFR Part 807.97).
the regulation entitled, "Misbranding by reference to premarket not from the Di the regulation entitled, "Misolanding by reference to promobilities under the Division
You may obtain other general information on your responsibilities under her You may obtain other general information on your Assistance at its toll-free number or Sman Mandraetar01) 443-6597 or at its Internet address (000) 0500 . fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health
5
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K040413
Device Name: Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System is indicated for the palliation . The Cordis in the biliary tree.
Prescription Use _L (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Tomm D. Lyson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.