(21 days)
Not Found
Not Found
No
The summary describes a mechanical stent and delivery system with no mention of AI or ML capabilities.
Yes.
The device is intended as a "palliative treatment for malignant neoplasms in the biliary tree", indicating it is used to manage symptoms and improve quality of life for a medical condition.
No
The device is described as a stent and delivery system intended as a palliative treatment for malignant neoplasms, not for detecting, monitoring, or diagnosing a condition.
No
The device description clearly states it is a physical stent and delivery system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the ev3 ParaMount™ Mini Stent and Delivery System is a physical device (a stent and delivery system) that is implanted into the biliary tree. It is used for palliative treatment of malignant neoplasms.
- Intended Use: The intended use is to provide a physical treatment (palliative) within the body, not to analyze a sample taken from the body.
Therefore, based on the provided information, this device is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ParaMount™ Mini Stent and Delivery Device is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The ev3 ParaMount™ Mini Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The ParaMount™ Mini 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the ParaMount" Mini Stent and Delivery Device meet the requirements that are considered acceptable for the intended use.
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.
Not Found
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
Premarket Notification (510(k)) Summary
| 510(k) Number: | K032206 | |
|---|---|---|
| Product Name: | ParaMount™ Mini Stent and Delivery System (Biliary Indication) | |
| Common Name: | biliary stent |
Class: Class II, 21 CFR 876.5010
| Submitter's Name: | Official Contact: |
|---|---|
| ev3 Inc. | Glen D. Smythe |
| 4600 Nathan Lane North | Regulatory Affairs Associate |
| Plymouth, MN 55442 | Telephone: 651-697-4815 |
| Fax: 651-697-2080 |
15 July 2003 Summary Preparation Date:
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 IntraStent® DoubleStrut™ ParaMount™ Stent.
The ParaMount™ Mini Stent and Delivery Device is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The ParaMount™ Mini 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 currently marketed stent and delivery system in intended use, materials, technological characteristics and performance. The stent was modified to provide increased radiopacity. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the ParaMount" Mini Stent and Delivery Device meet 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.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle with three lines forming its body and wings. The eagle faces to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Mr. Glen D. Smythe Regulatory Affairs Associate ev3. Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920
Re: K032206
Trade/Device Name: Paramount " Mini 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: July 17, 2003 Received: July 18, 2003
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 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. Glen Smythe
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 (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,
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K032206
Device Name: ev3 ParaMount™ Mini Stent and Delivery System
FDA's Statement of the Indications For Use for device:
The ev3 ParaMount™ Mini Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
David R. Stoyrer
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _