(90 days)
No
The summary describes a physiological navigation system that uses on-line recording and stimulation of brain activity for localization and assessment. There is no mention of AI, ML, or related terms, nor is there any description of training or test sets which are typical for AI/ML device submissions. The focus is on real-time physiological data analysis by the neurosurgeon.
No
The device aids neurosurgeons in targeting for functional neurosurgery and electrode placement, but it does not directly treat or alleviate a disease or condition itself.
Yes
The device assists in optimal target localization and provides "on line" assessment of electrophysiological activity to guide neurosurgical procedures and confirm target structure position, which are diagnostic functions.
No
The device description explicitly mentions a "microelectrode is advanced into the brain with on-line recording and stimulation performed," indicating the presence of hardware components beyond just software.
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.
- NeuroTrek Function: The NeuroTrek system works by directly interacting with the brain in vivo (within the living body) during surgery. It records electrical activity and stimulates brain tissue.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient.
The NeuroTrek is a surgical navigation and physiological monitoring system used during a surgical procedure, not a device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.
Product codes
84 GZL
Device Description
The NeuroTrek is a physiological navigation system designed for clinical use during Pallidotomy or Thalamotomy and other neurosurgical procedures to assist in optimal target localization.
During surgery, a microelectrode is advanced into the brain with on-line recording and stimulation performed for precise focusing on the target organ and for evaluating the symptoms before and after. The physiological navigation and localization during the procedure is done for achieving better clinical results (short and long term). "On line" assessment of the electrophysiological activity assures the doctors that they are not about to cause irreversible damage to adjacent centers (i.e. Vision, Somatosensory), and allows confirmation of the target structure position.
The NeuroTrek system also enables design boundaries of target and localization of part position of the target for lesioning and electrode implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgeons in the operating room
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
510(k) Summary
Alpha Omega Ltd.
NeuroTrek
Physiological Navigation System for Neurosurgery 510(k) Number K 993622
Submitter's Name:
Alpha Omega Ltd. Ha'avoda Street, P.O.Box 810 Nazareth Illit 17105, Israel Tel: 972-6-6563327 Fax: 972-6-6574075
Contact Person:
Shoshana Friedman 117 Ahuzah St. Ra'ananna 43373, Israel Tel: 972-9-771-8130 Fax: 972-9-771-8130
Trade Name:
NeuroTrek
Classification Name:
Depth Electrode
Classification:
The FDA has classified these devices as class II device (product code 84 GZL) and are reviewed by the Neurology panel.
1
Predicate Devices:
The NeuroTrek system is substantially equivalent to:
- · Guideline System 3000 (Axon Instruments, Inc), cleared under K970943.
- · NeuroMap (RADIONICS), cleared under K981820.
Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food. Drug, and Cosmetic Act. However, the NeuroTrek Physiological Navigation System for Neurosurgery complies with the following voluntary standards: IEC 601-1, IEC 601-1-2,IEC 601-1-4.
Indication for Use:
Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.
Device Description:
The NeuroTrek is a physiological navigation system designed for clinical use during Pallidotomy or Thalamotomy and other neurosurgical procedures to assist in optimal target localization.
During surgery, a microelectrode is advanced into the brain with on-line recording and stimulation performed for precise focusing on the target organ and for evaluating the symptoms before and after. The physiological navigation and localization during the procedure is done for achieving better clinical results (short and long term). "On line" assessment of the electrophysiological activity assures the doctors that they are not about to cause irreversible damage to adjacent centers (i.e. Vision, Somatosensory), and allows confirmation of the target structure position.
The NeuroTrek system also enables design boundaries of target and localization of part position of the target for lesioning and electrode implantation.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 24 2000
Ms. Shoshana Friedman, RAC. General Manager Alpha Omega Ltd. C/O Push-Med Ltd 117, Ahuza Street Ra'ananna 43373 Israel
Re: K993622
Trade Name: NeuroTrek System Regulatory Class: II Product Code: GZL Dated: October 20, 1999 Received: October 26, 1999
Dear Ms. Friedman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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.
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 affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.
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
3
Page 2 - Ms. Shoshana Friedman, RAC.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
K 993622 510(k) Number (if known):
NeuroTrek system Device Name:
Indications for Use: Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K993622
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Rgg36222 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use_