(183 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard EEG recording and analysis functions.
No
The device is described as aiding in diagnosis by recording, measuring, and displaying cerebral and extracerebral activity, but it does not directly treat or provide therapy.
Yes
The device is described as aiding in diagnosis for Sleep Disorder, Epilepsies, and other related disorders, and provides information for intervention by recording, analyzing, and displaying brain action potentials.
No
The device description explicitly states it is an "instrument" that "can measure the vital signal" and "display the waveform on the screen," indicating it includes hardware components for signal acquisition and display, not just software.
Based on the provided information, the EEG-1200A Series Neurofax is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis. The EEG-1200A Series Neurofax directly measures electrical activity from the brain and other parts of the body using electrodes placed on the skin. It does not analyze biological samples.
- The intended use describes recording, measuring, and displaying cerebral and extracerebral activity. This is a direct measurement of physiological signals, not the analysis of a biological specimen.
- The device description details the instrument's ability to measure vital signals and display waveforms. This aligns with a device that directly interacts with the patient to capture physiological data.
Therefore, the EEG-1200A Series Neurofax is a medical device used for physiological monitoring and recording, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EEG-1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
Product codes
OLT, OLV, GWQ
Device Description
The EEG-1200A Electroencephalograph is the instrument to provide the information for intervention to utilize derivation, recording, analysis, or each combination of the brain's action potential. The instrument can measure the vital signal (including ECG waveform, EMG waveform, respiration waveform, ocular motility, SpO2 and CO2) in relation to EEG examination and display the waveform on the screen changing the montage and amplifier conditions. In addition, measurement data is available to file into the electric media. Changing the montage and amplifier conditions, then record to the printer, previews the measured data filed into the electric media. EEG data analysis is also executed to use the analysis software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral and extracerebral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
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)
The EEG-1200A Series was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions for acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nihon Kohden EEG-1100A Series and Accessories per 510(k) K992742
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
NIHON KOHDEN AMERICA, INC.
SECTION 2- 510(K) SUMMARY
Name and Address of Applicant
Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610
AUG 2 9 2008 Contact: Jack Coggan Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550
Trade/Device Name:
EEG-1200A Series Neurofax
Common or Usual Name:
Electroencephalograph (EEG)
Classification Name:
The device has been classified as Class 2 by the Neurology Device Classification Panel under 21 CFR Part 882.1400 Electroencephalograph per GWQ, OLLT C C V
Legally Marketed Predicate Device:
Nihon Kohden EEG-1100A Series and Accessories per 510(k) K992742 commercial distribution certification dated October 14, 1999.
Intended Use:
The EEG-1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
A summary of the technological characteristics of the device compared to the predicate device: The new EEG-1200A Series Neurofax technological characteristics differences compared to the predicate device are:
Comparison | New Device | Predicate Device |
---|---|---|
Number of channels | 32 | 40 |
Noise Level |