(16 days)
Not Found
Not Found
No
The summary describes a mechanical stent and delivery system with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended as a "palliative treatment for malignant neoplasms in the biliary tree," indicating a therapeutic purpose.
No
Explanation: The device is described as a stent and delivery system intended as a palliative treatment for malignant neoplasms in the biliary tree. Its function is to expand and conform to the duct, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a physical stent made of stainless steel and a balloon 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 "as a palliative treatment for malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body, not a test performed on a sample taken from the body.
- Device Description: The device is a stent and delivery system designed to be implanted in the biliary tree. This is a medical device used for treatment, not for diagnosing a condition by analyzing a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the ev3 PRIMUS™ Stent and Delivery System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ev3 PRIMUS™ Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
Product codes
78 FGE
Device Description
The PRIMUS" Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
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
Bench testing was performed.
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
DEC - 9 2004
Premarket Notification (510(k)) Summary
| 510(k) Number: | K043243 |
|---|---|
| Product Name: | PRIMUS TM Stent and Delivery System (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | ev3 Inc. |
| 4600 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Official Contact: | Glen D. Smythe |
| Sr. Regulatory Affairs Specialist | |
| Telephone: 763-398-7391 | |
| Fax: 763-398-7200 | |
| Summary Preparation Date: | November 22, 2004 |
This summary is provided in compliance with section 513(1)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the PRIMUS™ Stent and Delivery System.
The PRIMUS™ Stent and Delivery Device is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The PRIMUS" Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The modified device is substantially equivalent* to the previously cleared stent and delivery system in intended use, materials, technological characteristics and performance. The stent was modified to provide additional diameters and lengths. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the PRIMUS " Stent and Delivery Device 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 36 of the US Code.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Mr. Glen D. Smythe Senior Regulatory Affairs Specialist ev3. Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920
Re: K043243
Trade/Device Name: ev3 PRIMUS™ Stent and Delivery System (Biliary Indication) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 22, 2004 Received: November 23, 2004
Dear Mr. Smythe:
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 for are card in 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 ano Gooms of the Act and the limitations described below. The general controls provisions of the provisions of the 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 - Mr. Glen D. Smythe
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I least note that the a0010 moving before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate The I DA Intelling of basification for your device and permits your device to proceed to the de rice results in a classification of 7 begin marketing your device as described in your Section market. " This letter will ation if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elabilities (oo abouteds. 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 r lease of advised that I Drivice and that your device complies with other requirements of the Act that I Dri has intate a and regulations administered by other Federal agencies. You must or any I caelares and 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 CITY art 607), aboning (21 CFR Part 807), good the start 820); and if applicable, the electronic form in the quality by tellions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your 11 you desire specific most please contact the Office of Compliance at (240) 276-0115. Also, de rice (21 er RT an 001), product on Misbranding by reference to premarket notification' (21 prease note the regaration other general information on your responsibilities under the CITY at 007.97): "You may outlar offacturers, 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. Director Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known): K043243
Device Name: ev3 PRIMUSTM Stent and Delivery System (Biliary Indication)
Indications For Use:
The ev3 PRIMUS™ Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broydon
(Division Sign-Off)
and Radiological De 510(k) Number
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