(58 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical device (a stent) and its delivery system. There is no mention of software, image processing, AI, ML, or any data-driven components that would suggest the use of AI/ML technology. The performance studies mentioned are bench tests, not clinical studies involving data analysis that might utilize AI/ML.
Yes
The device is intended as a "palliative treatment of malignant neoplasms in the biliary tree" and "for palliation of malignant strictures in the biliary tree," which clearly indicates a therapeutic purpose.
No
Explanation: The device is a self-expanding stent system intended for palliative treatment of malignant neoplasms or strictures in the biliary tree, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical stent made of nitinol and a delivery catheter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is a "palliative treatment of malignant neoplasms in the biliary tree" and "palliation of malignant strictures in the biliary tree." This describes a therapeutic intervention performed within the body to treat a condition.
- Device Description: The device is a "self-expanding nitinol stent" that is "provided premounted on a delivery catheter." This is a physical implantable device used to open up a blocked passage.
- Anatomical Site: The device is used in the "biliary tree," which is an internal anatomical structure.
IVDs are devices used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is clearly used in vivo (within the body) for treatment.
N/A
Intended Use / Indications for Use
The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Product codes
FGE
Device Description
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.
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
The modified device is substantially equivalent to the currently marketed stent and delivery system in intended use, materials, technological characteristics and performance. Additional more flexible stent models have been added to the 6Fr 0.035" delivery system. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé® EverFlex™Self-Expanding Biliary Stent System meets the requirements that are considered acceptable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
rage 1851
MAR 8 2006
Premarket Notification (510(k)) Summary
| 510(k) Number: | K060057 |
|---|---|
| Product Name: | Protégé® EverFlex™ |
| Self-Expanding Biliary Stent System | |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | ev3 Inc. |
| 9600 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Official Contact: | Melissa Sommerfeld |
| Regulatory Affairs Specialist | |
| Telephone: 763-398-7612 | |
| Fax: 763-398-7200 | |
| Summary Preparation Date: | January 6, 2005 |
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the Protégé® EverFlex™ Self-Expanding Biliary Stent System.
The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.
The modified device is substantially equivalent* to the currently marketed stent and delivery system in intended use, materials, technological characteristics and performance. Additional more flexible stent models have been added to the 6Fr 0.035" delivery system. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé® EverFlex™Self-Expanding Biliary Stent System meets the requirements that are considered acceptable for the intended use.
*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 35 of the US Code.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2006
Ms. Melissa Sommerfeld Regulatory Affairs Specialist ev3 Inc. 4600 Nathan Lane North PLYMOUTH MN 55442
Re: K060057
Trade/Device Name: Protégé® EverFlex™ Self-Expanding Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 3, 2006 Received: February 6, 2006
Dear Ms. Sommerfeld:
We have reviewed your Section 510(k) premarket notification of intent to market the device w for how e a your ca your sectermined the device is substantially equivalent (for the indications for referentod in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the encreat date of the Medical Device Amendments, or to devices that prior to thay 20, 1970, are cordance 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.
2
Page 2 -- Ms. Melissa Sommerfeld
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your do the navilional controls. Existing major regulations affecting your device can be found indy 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 described above is added to your labeling.
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), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Afrotem for
Donna Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K060057 -----
Device Name: Protégé® EverFlex™ Self-Expanding Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Prescription Use _ V (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Nancuc trogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060057