(87 days)
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is a balloon-expandable, stainless steel stent that is provided mounted upon its balloon catheter delivery device. The Cordis JUPITER Balloon Catheters are used for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent. These balloon catheters are substantially equivalent to the balloon catheter delivery devices used with the aforementioned predicate Cordis device.
The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided with the stent and its delivery 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 removed.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is provided sterile and is intended for single use only.
The provided text describes a 510(k) submission for a medical device, the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System. The acceptance criteria and supporting study are described in terms of substantial equivalence to a predicate device, rather than a clinical performance study with specific metrics like sensitivity or specificity. This is common for 510(k) submissions for devices that are line extensions or modifications of already cleared devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent in design, material, components, method of delivery, fundamental technology, and intended use as the predicate Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System (K990631). | The subject device "represents a line extension to the predicate Cordis stent and delivery system which allows for the use of an alternate balloon catheter delivery device." The "Cordis JUPITER Balloon Catheters are used for the delivery... These balloon catheters are substantially equivalent to the balloon catheter delivery devices used with the aforementioned predicate Cordis device." The subject device "incorporates the same method of deployment, fundamental technology and intended use as those found with the predicate Cordis biliary stent and delivery system." |
| Demonstrated safety and effectiveness. | "The safety and effectiveness... have been demonstrated via data collected from nonclinical tests and analyses." (Specific metrics are not provided in this summary, as is typical for 510(k) which relies on substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "The safety and effectiveness of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System have been demonstrated via data collected from nonclinical tests and analyses."
- Sample Size: Not applicable in the traditional sense of a clinical study with patients. The nonclinical tests would have involved physical or mechanical testing of the device and its components. The specific number of devices tested or the specifications of those nonclinical tests are not detailed in this summary.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for nonclinical tests. These tests are typically conducted in a laboratory setting by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not provided as the submission relies on nonclinical testing and substantial equivalence to a predicate device, not on expert-adjudicated clinical data.
4. Adjudication Method for the Test Set
- This information is not provided as the submission relies on nonclinical testing and substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and nonclinical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No, this is not an AI/algorithm-based device. It is a physical medical device (stent and delivery system), so a standalone algorithm study is not applicable.
7. The Type of Ground Truth Used
- For the purposes of this 510(k) submission, the "ground truth" is established through bench testing and engineering analysis demonstrating that the device performs as intended and is equivalent to the predicate device in terms of material properties, dimensions, deployment mechanism, and overall function. There is no biological or diagnostic "ground truth" as would be established through pathology or outcomes data for an AI or diagnostic device.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for this type of device.
In summary:
This 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared predicate device. The "study" proving the device meets the acceptance criteria (which is substantial equivalence) consists of nonclinical tests and analyses comparing the subject device's design, materials, components, and performance characteristics to those of the predicate. This approach is standard for line extensions of existing devices to streamline regulatory review when no new safety or effectiveness concerns are raised by the modifications. No clinical studies involving human subjects, expert adjudication, or AI model training are described or required for this type of submission.
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K991674 p. 1/3
510(k) Summary of Safety and Effectiveness
| Submitter: | Cordis Corporation, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059 | |
|---|---|---|
| Telephone: | (908) 412-7446 | |
| Fax: | (908) 412-3915 | |
| Contact Person: | Charles J. RyanManager, Regulatory AffairsCordis Corporation, a Johnson & Johnson Company40 Technology DriveWarren, New Jersey 07059 | |
| Telephone: | (908) 412-7446 | |
| Fax: | (908) 412-3915 | |
| Date Prepared: | May 14, 1999 | |
| Trade Name: | Cordis PALMAZ CORINTHIAN Transhepatic BiliaryStent and Delivery System | |
| Common Name: | Biliary Stent and Delivery Catheter | |
| Classification Name: | Biliary Catheter and Accessories (per 21 CFR 876.5010) | |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The design, material, components, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System are substantially equivalent to those featured with the predicate Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System (see 510(k) #K990631).
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K991674 p.2/3
510(k) Premarket Notification
In short, the subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System represents a line extension to the predicate Cordis stent and delivery system which allows for the use of an alternate balloon catheter delivery device.
Device Description:
The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is a balloon-expandable, stainless steel stent that is provided mounted upon its balloon catheter delivery device. The Cordis JUPITER Balloon Catheters are used for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent. These balloon catheters are substantially equivalent to the balloon catheter delivery devices used with the aforementioned predicate Cordis device.
The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided with the stent and its delivery 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 removed.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is provided sterile and is intended for single use only.
Intended Use:
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Technological Characteristics:
The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System incorporates the same method of deployment, fundamental technology and intended use as those found with the predicate Cordis biliary stent and delivery system. The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System features an alternative balloon catheter delivery device that is substantially equivalent to that found with the predicate Cordis biliary stent and delivery system.
The subject PALMAZ CORINTHIAN Stent is provided in a range of unexpanded lengths from 15 to 18 mm and in a range of expanded diameters from 5 to 6 mm.
Performance Data:
The safety and effectiveness of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System have been demonstrated via data collected from nonclinical tests and analyses.
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K991674 p. 3/3
PALMAZ® CORINTIIIAN™ Transhepatic Biliary Stent and Delivery System Cordis Corporation, a Johnson & Johnson Company
510(k) Premarket Notification
A statement of substantial equivalence to another product is required by 21 CFR A statement of substantial equit as the present product can be marketed without ov/.o / and relates only to whenler movel. The present submission is therefore not prior reclassification of cinners appt and is not to be interpreted as an admission or i clared to the coverage of any pringement lawsuit. As the commissioner of the used as CVIdence in a pavent marked ander the Federal Food, Drug
stated, "A determination of substantial equivalence under the Federal started stated, "A decermination of be fact that the product can be lawfully marketed and Cosment Act realers wo the reclassification. This determination is not intended without pre-market upprover on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).
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Image /page/3/Picture/14 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 1999
Mr. Charles J. Ryan Manager, Regulatory Affairs Cordis Corporation, a Johnson & Johnson Company P.O. Box 4917 Warren, New Jersey 07059
Re: K991674
K991674
Cordis PALMAZ® CORINTHIAN™ Transhepatic Biliary Stent and Delivery System Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: May 14, 1999 Received: May 17, 1999
Dear Mr. Ryan:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section > rocky notined to the indications for use indications for use above and we nave delemined the devices marketed in interstate commerce stated in the enclosure) to legally marketed processor and ments, or to devices that prior to May 26, 1970, the chacment dato of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls of Act (Act). You may, therefore, market and as now , cary of controls provisions of the Act include the Act and the minitations desortoed below. - The 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 I he Olice of Device Evaluation has determined in the proposed labeling and that such use device will be used for all meended ass not a with Section 513(i)(I)(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 I ulthermore, the midledion for binary box for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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
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Page 2 -- Mr. Charles J. Ryan
i affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895.
The County of the formation assumes compliance with the Current Good affecting your device can be found in the Coundiance with the Current Good
A substantially equivalent determination assumes compliance with the Current Regulation ( A substantially equivalent determination assumes complanoc while many of them Regulation (QS) for
Manufacturing Practice requirements, as set forth in the Quality System Regu Manufacturing Practice requirements, as set lordin and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic of a Medical Devices: General regulation (PDA) will vifty such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assumptions) Follur inspections, the Food and Drug Administration (FDA) will vents comply with the GMP regulation may result in the Federal Register. Please note: this further announcements concerning your devices in the regence. response to your premarket notification submission and the Electronic Product Ration
under sections 531 through 542 of the Act for devices under the Electronic Product Radiat under sections 551 through overal 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 proceed to the market. This
results in a classification for your device and permits your device to proceed to th results in a classification for your device and penines your device in your 510(k) premarket
letter will allow you to begin marketing your device as described. letter will allow you to begin marketing your device as associety of the subscribed.
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.
The Act. In and Management before these limitations are modified in any way o Please note that the above labeling limitations are required by Boals. For ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) 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 the application of our and devices), please contact
device (21 CFR Part 801 and 2011 11/16 - Aditionally for guestions on the promoti device (21 CFR Part 801 and additionally 809.10 lot millio cultures on the promotion and the Office of Compliance at (301) 394-4610. Administrat (301) 594-4639. Also,
advertising of your device, please contact the Office of Compliance at (301) 594-4639. advertising of your device, please contact the online of estage to premarket notification"
please note the regulation entitled, "Misbranding by reference to premarket notific please note the regulation entitled, "Misor for responsibilities under the Act may be
(21 CFR 807.97). Other general information on your responsibilities under the Act may be (21 CFR 807.97). Other general miormation on your sistem at its toll-free number
obtained from the Division of Small Manufacturers Assistance at its toll-free number obtained from the Driston of S597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Sumafro
Susan Alpert, Ph.D., M Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510 (k) Number:
Device Name:
Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System
Indications For Use:
The Cordis PALMAZ CORNTHIAN Stent and Delivery System is indicated for the palliation
of malignant neonlasms in the bilians tree of malignant neoplasms in the biliary tree.
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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _____________ (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) f Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number 991674 :
§ 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.