(182 days)
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Not Found
No
The summary describes a system for displaying and storing electrophysiological data for manual analysis by neurosurgeons. There is no mention of automated analysis, pattern recognition, or any terms associated with AI/ML.
No.
The device assists neurosurgeons by displaying and storing electrophysiological activity, helping them locate brain structures. It does not directly treat or prevent a disease or condition.
Yes
The device is used to examine and analyze electrical signals to determine the location of certain brain structures, which is a diagnostic function.
No
The device description explicitly states that the system displays and stores electrophysiological activity "relayed from electrodes placed within the brain and on the surface of the skin." This indicates the system includes hardware components (electrodes and likely associated signal acquisition hardware) in addition to the software for display and storage.
Based on the provided information, the Radionics, Inc. NeuroMap™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NeuroMap™ system, as described, directly measures electrophysiological activity within the brain and on the skin surface of a living patient.
- The intended use is to assist neurosurgeons in the operating room during functional neurosurgery by analyzing electrical signals from the CNS. This is a direct measurement of physiological activity in a living subject, not the analysis of a specimen in vitro (outside the body).
The NeuroMap™ is a device used for physiological monitoring and analysis during a surgical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Radionics, Inc. NeuroMap™ is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery. The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin. NeuroMap™ helps the neurosurgeons determine the location of certain brain structures before lesioning is performed by allowing them to examine and analyze the electrical signals.
Product codes
GZL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
brain, CNS
Indicated Patient Age Range
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Intended User / Care Setting
neurosurgeons, operating room
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.
NOV 20 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey R. Mannion Senior Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
Re: K981820 Trade Name: NeuroMap™ Regulatory Class: II Product Code: GZL Dated: August 24, 1998 Received: August 25, 1998
Dear Mr. Mannion:
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 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. 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 requirements, as set forth in the Quality System Regulation (OS) 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 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.
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Page 2 - Mr. Jeffrey R. Mannion
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 (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/dsma/dsmamain.html".
Sincerely yours,
Acelly
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) NUMBER (IF KNOWN): | K 981820 |
|---|---|
| DEVICE NAME: | Radionics Inc. NeuroMan™ |
INDICATIONS FOR USE:
The Radionics, Inc. NeuroMap™ is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery. The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin. NeuroMap™ helps the neurosurgeons determine the location of certain brain structures before lesioning is performed by allowing them to examine and analyze the electrical signals.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981820