(90 days)
Not Found
No
The device description focuses on the mechanical aspects of the catheter and its function for infusion and navigation. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as being for the "infusion of various diagnostic, embolic and therapeutic agents" and for the "treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms" which aligns with a therapeutic purpose.
No
The device is an infusion catheter, which is used to deliver diagnostic, embolic, and therapeutic agents. While it can deliver diagnostic agents and aid in visualization, its function is delivery, not diagnostic analysis or interpretation itself.
No
The device description clearly details a physical catheter with a nitinol mandrel, plastic hoop assembly, pouch, and sterilization process, indicating it is a hardware device, not software-only.
Based on the provided information, the NeuroEdge™ Infusion Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of various agents into the neurovasculature for diagnosis, visualization, and treatment. This involves direct interaction with the patient's body (in vivo).
- Device Description: The device is a catheter designed to be inserted into the neurovasculature. It delivers substances directly into the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device does not perform such analysis on specimens.
The NeuroEdge™ Infusion Catheter is a medical device used for therapeutic and diagnostic procedures performed within the patient's body.
N/A
Intended Use / Indications for Use
The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The NeuroEdge™ Infusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroEdge™ Infusion Catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid agents (such as contrast media and liquid embolic glues) through the end hole at select sites in the neurovasculature for the diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms. The catheter is also designed to penetrate an embolism if it is determined to be a soft thrombus and navigate through the thrombus to assess the circulation distal to the thrombus.
The NeuroEdge™ Infusion Catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized via gamma radiation sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature
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 was completed to verify the design specifications necessary for the open-ended modification and to support the compatibility of the catheter to deliver embolic / therapeutic agents. Test results support the safety and performance of the NeuroEdge™ Infusion Catheter for its 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.
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
011646 1/2
AUG 2 7 2001
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Submitter's Name / Contact Person
| Jack Slovick | Tel: (763) 315-0013 |
|---|---|
| Director, Quality and Regulatory Affairs | Fax: (763) 315-0966 |
NeuroVasx, Inc. 7351 Kirkwood Lane, Suite 112 Maple Grove, MN 55369
2. General Information
| Trade Name: | NeuroEdge™ Infusion Catheter |
|---|---|
| Classification Name: | Continuous Flush Catheter |
| Classification: | This device is classified by the Circulatory Systems Device |
| Panel into Class II, (21 CFR 870.1210) |
3. Device Description
The NeuroEdge™ Infusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroEdge™ Infusion Catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid agents (such as contrast media and liquid embolic glues) through the end hole at select sites in the neurovasculature for the diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms. The catheter is also designed to penetrate an embolism if it is determined to be a soft thrombus and navigate through the thrombus to assess the circulation distal to the thrombus.
The NeuroEdge™ Infusion Catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized via gamma radiation sterilization process. (See Attachment B for device drawings.)
4. Intended Use
The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.
CONFIDENTIAL
1
5. Substantial Equivalence Comparison
The NeuroEdge Infusion Catheter is substantially equivalent to the following devices with respect to intended use, design, materials and construction:
- NeuroVasx Sub-MicroInfusion Catheter, NeuroVasx Inc. (K984258) o
- Prowler™-10 Infusion Catheter, Cordis Endovascular Systems Inc. (K003925) o
- LTD Torque Device, B. Braun Medical, (K964352) o
6. Summary of Studies
Performance testing was completed to verify the design specifications necessary for the open-ended modification and to support the compatibility of the catheter to deliver embolic / therapeutic agents. Test results support the safety and performance of the NeuroEdge™ Infusion Catheter for its intended use.
7. Conclusion (statement of equivalence)
The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the NeuroEdge™ Infusion Catheter.
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
AUG 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jack Slovick Director, Regulatory Affairs/Quality Assurance NeuroVasx, Inc. 7351 Kirkwood Lane, Suite 112 Maple Grove, Minnesota 55369
Re: K011646
R011040
Trade/Device Name: NeuroEdge™ Infusion Catheter Regulation Number: 870.1210 Regulatory Class: II Product Code: KRA Dated: May 25, 2001 Received: May 29, 2001
Dear Mr. Slovick:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon - I oxil iteminally equivalent (for the indications for use above and we nave determined the actives is eadicate devices marketed in interstate commerce stated in the encrosule) to legally manated problem Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and flave been reclassified in accordance thre device, subject to the general controls Cosment Act (Act). Tou may, morelors, marcols, marcoisions of the Act include requirements for annual provisions of the Act. "The general oversions practice, labeling, and prohibitions against misbranding and adulteration.
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 (1 children rippt vary, it 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 mspotions, the Food and 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.
3
Page 2 - Mr. Juan Carlos Rivera
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607110 for questions on the promotion and advertising of your device, (201) 594-1659. Practicenary), and (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or 11allanderal or attitutionet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark N. Milkins
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1 of 1
The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SR
(Division Sign -Off) Division of General, Restorative and Neurological Devices
510(k) Number K011646
MAY 25, 2001