(128 days)
No
The device description and performance studies focus on the mechanical properties and delivery system of a stent and balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is indicated for "palliation of malignant neoplasms in the biliary tree" and to "dilate stenoses" and for "treatment of obstructive lesions," all of which imply a therapeutic intent to improve a patient's health condition.
No.
The device descriptions and stated indications for use (palliation of malignant neoplasms, dilation of stenoses, treatment of obstructive lesions) clearly indicate that this device is intended for therapeutic intervention, not for diagnosis.
No
The device description clearly details a physical, balloon-expandable stainless steel stent and associated hardware components (catheters, crimping tubes, crimping tools, introducer tube). There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the PALMAZ CORINTHIAN Transhepatic Biliary Stent and the OPTA LP Balloon Catheter are devices used within the body to treat physical obstructions in the biliary tree and arteries. They are implanted or used to dilate vessels.
- Intended Use: The intended use is for the palliation of malignant neoplasms in the biliary tree and dilation of stenoses in various arteries and fistulae. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.
Certain sizes of the OPTA LP Balloon Catheter are indicated for deployment of the PALMAZ CORINTHIAN Transhepatic Biliary Stent in the biliary system.
Also, the OPTA LP Balloon Catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This is the same intended use previously cleared for this balloon catheter (via 510(k) #K971448 and #K981407).
FDA's Statement of the Indications For Use for device:
The PALMAZ CORINTHIAN Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Certain sizes of the OPTA LP catheters are indicated for deployment of 6-10 mm diameter x 4-10 cm length PALMAZ CORINTHIAN Transhepatic Biliary Stents. The clinical indications for these stents are described in their Instructions for Use.
Additionally, the OPTA LP catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
78 FGE
Device Description
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is mounted upon its recommended balloon catheter delivery device via the use of accessory devices – plastic crimping tubes, which are provided with the packaged stent, and crimping tools, which are provided separately. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, 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 removed.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and the OPTA LP Balloon Catheter are provided sterile and are intended for single use only.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is provided in a range of nominal, unexpanded lengths from 40 to 100 mm and can be expanded to diameters from 6 to 10 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree, iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries, arteriovenous dialysis fistulae
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 CORINTHIAN Transhepatic Biliary Stent and its OPTA LP Balloon Catheter delivery device have been demonstrated via data collected from non-clinical design verification tests and analyses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K964688, K905720, K911581, K990631
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
| AUG - 4 1999
510(k)
| Summary of Safety and Effectiveness | |
|---|---|
| Submitter: | Cordis Corporation, a Johnson & Johnson Company |
| 40 Technology Drive | |
| Warren, New Jersey 07059 | |
| Telephone: | (908) 755-8300 |
| Fax: | (908) 412-3915 |
| Contact Person: | Chuck Ryan |
| Manager, Regulatory Affairs | |
| Cordis Corporation, a Johnson & Johnson Company | |
| 40 Technology Drive | |
| Warren, New Jersey 07059 | |
| Telephone: | (908) 412-7446 |
| Fax: | (908) 412-3915 |
| Date Prepared: | May 5, 1999 |
| Trade Name: | Cordis PALMAZ® CORINTHIAN™ Transhepatic Biliary |
| Stent and OPTA LP Catheter | |
| Common Name: | Biliary Stent and Accessories |
| and Balloon Catheter | |
| Classification Name: | Biliary Catheter and Accessories (per 21 CFR 876.5010) |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent are substantially equivalent to those featured among predecessor Cordis biliary stents (see 510(k) #K905720, #K911581, and #K964688).
1
In short, the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent represents a line extension to its predecessor, the Cordis Long Medium PALMAZ-SCHATZ® Balloon-Expandable Stents (510(k) #K964688).
The Cordis OPTA® LP Balloon Catheter delivery device recommended for use with the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent represents a line extension to other Cordis balloon catheters that were previously determined substantially equivalent for biliary stent deployment (see 510(k) #K990631).
Device Description:
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is mounted upon its recommended balloon catheter delivery device via the use of accessory devices – plastic crimping tubes, which are provided with the packaged stent, and crimping tools, which are provided separately. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, 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 removed.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and the OPTA LP Balloon Catheter are provided sterile and are intended for single use only.
Intended Use:
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.
Certain sizes of the OPTA LP Balloon Catheter are indicated for deployment of the PALMAZ CORINTHIAN Transhepatic Biliary Stent in the biliary system.
Also, the OPTA LP Balloon Catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This is the same intended use previously cleared for this balloon catheter (via 510(k) #K971448 and #K981407).
Technological Characteristics:
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent incorporates the same method of deployment, materials, fundamental technology, intended use, and methods of manufacturing and sterilization as those found with its predicate Cordis Long Medium
2
PALMAZ-SCHATZ Balloon-Expandable Stents (see 510(k) #K964688). The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent incorporates a modified stent design that is substantially equivalent to that found with predicate Cordis metal biliary stents (see 510(k)s #K905720, #K911581, and #K964688).
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is provided in a range of nominal, unexpanded lengths from 40 to 100 mm and can be expanded to diameters from 6 to 10 mm.
Aside from the added indication for use as a delivery device for the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent, the Cordis OPTA LP Balloon Catheter remains identical to itself as represented in 510(k) #K971448 and #K981407 for use as a dilatation catheter.
Performance Data:
The safety and effectiveness of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and its OPTA LP Balloon Catheter delivery device have been demonstrated via data collected from non-clinical design verification tests and analyses.
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 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. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seg. (1977).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three wavy lines, which are meant to represent the human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1999
Mr. Chuck Ryan Manager, Regulatory Affairs Cordis, a Johnson & Johnson Company P.O. Box 4917 Warren, New Jersey 07059
Re: K991028
Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and OPTATM LP PTA Balloon Catheter for Biliary Stent Deployment Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: May 5, 1999 Received: May 6, 1999
Dear Mr. Ryan:
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 PALMAZ CORINTHIAN Transhepatic Biliary Stent'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 stent 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 - Mr. Chuck Ryan
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see above) microlas in (Spicing major regulations affecting your
Approval), it may be subject to such additional controls. Existing major regul Approval), it may be subject to such additions. Title 21, Parts 800 to 895. A substantially
device can be found in the Code of Federal Regulations, Title 21, Practice device can be found in the Code of Federal Regulances From Good Manufacturing Practice
equivalent determination assumes compliance with the Current Good Manufacturing Practic equivalent determination assumes compilance with the Ourlon Off of Medical Devices: General
requirements, as set forth in the Quality System Regulation (OS) for Medical Dev requirements, as set forth in the Quality System regulation (25) 2017
regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug regulation (21 CFR Part 820) and this, incough benouver in the GMP regulation Administration (FDA) will verity studion, FDA may publish further announcements concerning a may result in regulatory action. In addition, I this response to your premarket notification
your device in the Federal Register. Please note: this response to your progra your device in the Lederal Register. Fredse not: hus respenses to Joan for any of the of the submission does not aftect any obligation you may and between of the Federal laws or regulations.
The FDA finding of substantial equivalence of your device to a legally marketed proceed to the market. This The FDA finding of substantial equivalence of your device to proced to the market. This
results in a classification for your device and permits your device in pour 510(k) pr results in a classification for your device and penned in your 510(k) premarket
letter will allow you to begin marketing your device as described in your 510(lig. letter will allow you to begill marketing your dories as accomment above is as described.
In tification if the limitation statement above is added to your labeling, as descri
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act.
The Act of the School of the first the adjusited in any way or remove Please note that the above labeling immanons are required of Souther ( ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) from the device's labeling.
If you desire specific information about the application of other labeling requirements to your If you desire specific information about in applications or only of the spomotion and device (2T CFR Part 801 and additionally, for rolling westing on the promotion and Office of Compliance at (301) 394-4010. Additions of Compliance at (301) 594-4639. Also,
advertising of your device, please contact the Office of Compliance at (301) conse advertising of your device, please contact the other of econcert to premarket notification"
please note the regulation entitled, "Misbranding by references to premarket notif please note the regulation entitled, "Wissounsbilities under the Act may be
(21 CFR 807.97). Other general information on your responsibilities unimber (21 CFR 807.97). Offici general minuten and 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,
Sincerely yours,
Susan Albert
Susan Alpert, Ph.D., M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page _ 1 of 1
510(k) Number (if known): K991028
Device Name: _Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and OPTATM LP PTA Balloon Catheter for Biliary Stent Deployment
FDA's Statement of the Indications For Use for device:
The PALMAZ CORINTHIAN Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Certain sizes of the OPTA LP catheters are indicated for deployment of 6-10 mm diameter x 4-10 cm length PALMAZ CORINTHIAN Transhepatic Biliary Stents. The clinical indications for these stents are described in their Instructions for Use.
Additionally, the OPTA LP catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use
Skird A. Symon
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number