(30 days)
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.
The PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System is a balloon-expandable, stainless steel stent that is provided premounted upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed for expansion to diameters from 3 to 6 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile and is intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System), not a study that establishes acceptance criteria and proves the device meets those criteria.
The 510(k) process is used to demonstrate that a device is substantially equivalent to a predicate device, meaning it is at least as safe and effective. It does not typically involve the establishment of new acceptance criteria through clinical studies in the same way an investigational device exemption (IDE) or premarket approval (PMA) application would for novel devices.
Here's a breakdown based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. This document does not detail specific acceptance criteria for performance metrics that would be commonly found in a clinical study (e.g., success rates, complication rates, stent patency rates, etc.). | The document states: "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." No specific performance data (e.g., numerical results, percentages, etc.) is reported. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/Not provided. The document refers to "non-clinical design verification tests and analyses," which are typically bench testing and engineering verification, not human clinical trials with 'sample size' in the traditional sense of patient numbers.
- Data Provenance: Not applicable/Not provided. Since it's described as "non-clinical design verification," there is no country of origin for patient data or retrospective/prospective classification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not provided. This information pertains to studies where human experts evaluate cases to establish a "ground truth" (e.g., diagnosing disease from images). The provided text describes engineering verification tests, not expert-adjudicated clinical data.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. Pertains to expert review, which is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not mention any MRMC study, human reader performance, or AI assistance. The device in question is a physical medical device (stent), not a diagnostic AI algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This question is also not applicable as the device is a physical stent, not an algorithm.
7. Type of Ground Truth Used:
- Not explicitly stated in terms of "ground truth" for a clinical outcome. The "effectiveness" is demonstrated through "non-clinical design verification tests and analyses." This would imply that the "ground truth" for these tests would be compliance with engineering specifications, material properties, mechanical performance, etc., as determined by validated test methods.
8. Sample Size for the Training Set:
- Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. (Refer to point 8).
In summary:
This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical design verification tests and analyses for a physical medical device (biliary stent). It explicitly states that "Performance standards have not been established for this device by the FDA under section 514 of the Food, Drug and Cosmetic Act." Therefore, the document does not contain the information about acceptance criteria, clinical study designs, sample sizes for patient data, expert ground truth establishment, or AI-related metrics that your prompt requests.
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Cordis Europa N.V. , a Johnson & Johnson company Special 510(k) Premarket Notification
Attachment 1
KO12056
Summary of Safety and Effectiveness
| Submitter: | Harm HovingaRegulatory Affairs AssociateCordis Europa, N.V.Oosteinde 8NL-9301 LJ RodenThe NetherlandsTel: +31 - (5050) 22479Fax: +31 - (5050) 22456e-mail: hhovinga@crdnl.jnj.com |
|---|---|
| Contact person: | Chuck RyanManager, Regulatory AffairsCordis Corporation7 Powder Horn DriveWarren, New Jersey 07059USATel: 908.412.7446Fax: 908.412.3915e-mail: cryan@crdus.jnj.com |
| Date prepared | 29 June 2001. |
| General provisions | |
| Trade name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System. | |
| Common Name: Biliary stent and accessories | |
| Classification Name: 21 CFR 876.5010 Biliary Catheter. | |
| Device Classification | Class II. |
| Name of predicate device(s) | ➤ Cordis BX Transhepatic Biliary Stent and Delivery System (reference K001258)➤ Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent and Delivery System (ref. K992755 and K994156)➤ Cordis SLALOM PTA Balloon Catheter (ref. K003159) |
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Cordis Europa N.V. , a Johnson & Johnson company Special 510(k) Premarket Notification
| Performancestandards | Performance standards have not been established for this device by the FDA undersection 514 of the Food, Drug and Cosmetic Act. |
|---|---|
| DeviceDescription | The PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" DeliverySystem is a balloon-expandable, stainless steel stent that is provided premountedupon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided infour nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designedfor expansion to diameters from 3 to 6 mm, depending on the diameter of theassociated balloon upon which it is mounted.The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" DeliverySystem is provided sterile 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 thebiliary tree. |
| PerformanceData | The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic BiliaryStent on SLALOM .018" Delivery System has been demonstrated via data collectedfrom non-clinical design verification tests and analyses. |
| Biocompati-bility | All materials used in the PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM.018" Delivery System are biocompatible. |
| A statement of substantial equivalence to another product is required by 21CFR 807.87 and relates only to whether the present product can be marketedwithout prior reclassification or clinical approval. The present submission istherefore not related to the coverage of any patent and is not to be interpretedas an admission or used as evidence in a patent infringement lawsuit. As thecommissioner of the FDA stated: "A determination of substantial equivalenceunder the Fedral Food, Drug and Cosmetic Act releted to the fact that theproduct can be lawfully marketed without pre-market approval orreclassification. The determination is not intended to have any bearingwhatsoever on the resolution of patent infringement suits." 42 Federal Register42, 50 et seq. (1977). |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the three branches of government. The logo is surrounded by a circle of text that reads "U.S. Department of Health & Human Services - USA."
AUG 0 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cordis Europa, N.V. c/o Mr. Chuck Ryan, RAC Manager, Regulatory Affairs Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059
Re: K012056
Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: June 29, 2001 Received: July 2, 2001
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 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.
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Page 2 - Mr. Chuck Ryan, RAC
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. 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be 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". ﻬﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
Sincerely yours,
Bernard E. Statland, M.D., Ph.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
: 2
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510(k) Number (if known): K012056
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" The Court I ALTH LS & Sor the palliation of malignant neoplasms in the biliary tree.
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use
David C. Symons
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.