(214 days)
Not Found
No
The device description focuses on the material and mechanical properties of a self-expanding stent and delivery system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are bench tests comparing mechanical characteristics.
Yes
The device is described as a "palliative treatment of malignant neoplasms in the biliary tree" and is "intended for permanent implantation" to "establish patency," indicating it directly treats a medical condition.
No
The device is described as a self-expanding nitinol stent system intended for permanent implantation to treat malignant neoplasms, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description clearly states it is a "self-expanding nitinol stent system" and describes physical components like the stent, delivery system, and radiopaque markers. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a physical implantable device (a stent) intended to be placed inside the body (in the biliary tree) to treat a medical condition (malignant neoplasms). It does not involve the analysis of specimens taken from the body.
The device is a therapeutic device, not a diagnostic one.
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.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The PROTÉGÉ® EverFlex™ Self-Expanding Biliary Stent System is a self-expanding nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (nitinol) and comes pre-mounted on a 6F, 0.035" overthe-wire delivery system. The stent is cut from a nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency.
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)
Performance Data: Bench testing pertaining to performance characteristics was conducted on the 5mm Protégé EverFlex Self-Expanding Biliary Stent System and compared to the predicate device testing to demonstrate equivalency.
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.
K060057, K033537, K003793, K002143
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
510(k) Summary Protégé® EverFlex™ Self-Expanding Biliary Stent System
MAR 1 8 2008
510(k) Number: Y072301
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.
| Submitter/Contact Person: | |
|---|---|
| Applicant | |
| (Manufacturer) | ev3 |
| 4600 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Tel: (763) 398-7000 | |
| Fax: (763) 398-7200 | |
| Submitter's Name: | ev3 |
| 9600 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Tel: (763) 398-7000 | |
| Fax: (763) 398-7200 | |
| Official Contact: | Bruce Backlund |
| Sr. Regulatory Affairs Specialist | |
| ev3 | |
| 4600 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Tel: (763) 398-7612 | |
| Fax: (763) 398-7200 | |
| bbacklund@ev3.net | |
| Summary Preparation Date: | August 15, 2007 |
| Device Name and Classification: | |
| Trade Name: | Protégé® EverFlex™ |
| Self-Expanding Biliary Stent System | |
| Common Name/Usual Name: | Biliary Stent |
| Classification Name: | Biliary Catheter |
| Class: | Class II, 21 CFR 876.5010 |
Predicate Devices:
Protégé® EverFlex™ Self-Expanding Biliary Stent System (K060057)
Abbott Xpert™ Self-Expanding Transhepatic Biliary Stent System (K033537)
1
Bard® LUMINEXX™ Biliary Stent System (K003793)
Boston Scientific Sentinol TM (K032025)
DYNALINK™ Biliary Self-Expanding Stent System (K002143)
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.
Device Description:
The PROTÉGÉ® EverFlex™ Self-Expanding Biliary Stent System is a self-expanding nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (nitinol) and comes pre-mounted on a 6F, 0.035" overthe-wire delivery system. The stent is cut from a nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency.
Summary of Testing:
Biocompatibility: Biocompatibility was assessed and tested in accordance with ISO 10993 Part 1, "Biological Evaluation of Medical Devices," 1997(E) and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices".
Performance Data: Bench testing pertaining to performance characteristics was conducted on the 5mm Protégé EverFlex Self-Expanding Biliary Stent System and compared to the predicate device testing to demonstrate equivalency.
Statement of Equivalence:
The 5mm Protégé EverFlex Self-Expanding Biliary Stent System is substantially equivalent to the Protégé® EverFlex "Self-Expanding Biliary Stent System (K060057). Bard® LUMINEXX™ Biliary Stent System (K003793), Abbott Xpert™ Self-Expanding Transhepatic Biliary Stent System (K033537) and Abbott DYNALNK™ Biliary Self-Expanding Stent System (K002143)
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
MAR 1 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Worrell, MS, RAC Director, Regulatory Affairs ev36 Inc. 9600 54th Avenue North PLYMOUTH MN 55442-2111
Re: K072301
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: December 14, 2007 Received: December 17, 2007
Dear Mr. Worrell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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.
3
Page 2 - Mr. David Worrell
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 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 (240) 276-0115. 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,
Donna-Bea Tillman, Ph.D., M.P.H. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
K0723d/
Device Name: Protégé® EverFlex™ Self-Expanding Biliary Stent System
Indications for Use:
The Protégé® EverFlex™ Self-Expanding Biliary Stent System
: 上一篇:
is intended as a palliative treatment of malignant neoplasms in the biliary tree.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) | |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | -- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Page 1 of 1 | |
|---|---|
| Division Sign-off | |
| Division of Abdominal, | |
| 510(k) Number | K072301 |