(762 days)
No
The summary describes standard quantitative EEG analysis methods and does not mention AI, ML, or related concepts.
No
The device is described as an 8-channel EEG measuring unit intended to monitor brain function by amplifying and analyzing EEG waveforms and displaying the results. Its purpose is diagnostic or monitoring, not therapeutic.
Yes
The device amplifies and analyzes EEG, displays waveforms and analysis results, and calculates quantitative measures (SEF, MDF, etc.) intended to monitor and analyze brain function and the state of the brain. These functions are used for diagnostic purposes by medical personnel.
No
The device description explicitly states that the AE-918P is contained in a small enclosure that contains the EEG amplifier and digital circuitry, indicating it includes hardware components beyond just software.
Based on the provided information, the AE-918P EEG Neuro Unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- AE-918P Function: The AE-918P directly measures electrical activity from the brain (EEG) through electrodes placed on the patient's scalp. It amplifies, analyzes, and displays this physiological signal. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it is for "monitoring brain function" and analyzing the "EEG waveform." This is a direct measurement of a physiological process, not an analysis of a biological specimen.
Therefore, the AE-918P EEG Neuro Unit falls under the category of a medical device that performs physiological monitoring, but it is not an IVD.
N/A
Intended Use / Indications for Use
The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor.
The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.
The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home under direct supervision of a medical professional.
Product codes (comma separated list FDA assigned to the subject device)
OMA, OLT, OMC
Device Description
Electroencephalography (EEG) is the recording of electrical activity along the scalp. EEG measures voltage fluctuations resulting from ionic current flows within the neurons of the brain. In clinical contexts, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time, as recorded from multiple electrodes placed on the scalp.
The AE-918P is an 8 channel digital Electroencephalography (EEG) that connects to a Nihon Kohden patient monitor. It receives EEG data from patients and digitizes the signals, the waveforms and analysis are displayed on a Nihon Kohden Patient Monitor.
The AE-918P is contained in a small enclosure that contains the EEG amplifier and digital circuitry. This enclosure is mounted to the bottom of the patient monitor and connects to the patient monitor through the multilink cable.
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
medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home 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 AE-918P was subjected to safety and performance testing procedures. The AE-918P has undergone validation and verification testing to ensure conformance to all design requirements. Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of EEG trends. These tests verified that the device performed within specifications. No Clinical testing was required. Testing of the Nihon Kohden AE-918P Neuro Unit was performed in compliance with Nihon Kohden Corporation design control process. Testing to standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-26 was done. Electrodes used are the same as the predicate device and have been tested for biocompatibility according to ISO 10993-1.
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.
K051178, K963644, K021185, K120485, K131789
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
§ 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2015
Nihon Kohden Corporation c/o Natalie Kennel NJK & Associates, Inc 13721 Via Tres Vista San Diego, CA. 92129
Re: K130238
Trade/Device Name: Nihon Kohden AE-918P Neuro Unit Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMA, OLT, OMC Dated: February 3, 2015 Received: February 4, 2015
Dear Ms. Kennel:
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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Felipe Aquel -S
Carlos Peña, Ph.D., M.S. for Director, Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K130238
Device Name Nihon Kohden AE-918P Neuro Unit
Indications for Use (Describe)
The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor.
The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.
The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home under direct supervision of a medical professional.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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510(k) Summary
| Sponsor: | Nihon Kohden Corporation
1-31-4 Nishiochiai
Shinjuku-ku, Tokyo 161-8560 Japan |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Initial Importer/
Distributor | Nihon Kohden America, Inc.
15353 Barranca Parkway
Irvine, CA 92618 |
| Contact Person: | Ms. Natalie J. Kennel
Consultant
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego, CA 92129 USA
Phone: (858) 705-0350
Fax: (858) 764-9739
email: NKennel@njkconsulting.com |
Date Revised: March 2, 2015
DEVICE INFORMATION
| Proprietary Name: | AE-918P Neuro Unit |
|---|---|
| Common Name: | Electroencephalograph |
| Regulation section: | 21 CFR 882.1400 |
| Classification: | Class II |
| Product Code: | OMC |
| Panel: | Neurological |
| Predicate Device: | EEG-1200A Series Neurofax |
| K080546 | |
| Nihon Kohden |
4
Additional Predicates:
The following additional predicates support specific functionality in this system (Table 1).
| K# | Product | Manufacturer | Aspect |
|---|---|---|---|
| K051178 | MEE-1000 | Nihon Kohden | MDF function |
| K963644 | A-1050 | Aspect | MDF function |
| K021185 | Nervus Monitor | Nervus | Total Power |
| K120485 | QP-160AK | Nihon Kohden | aEEG |
| K131789 | Celebralogik | Mennen | aEEG |
| Table | 1 |
|---|---|
Product Description:
Electroencephalography (EEG) is the recording of electrical activity along the scalp. EEG measures voltage fluctuations resulting from ionic current flows within the neurons of the brain. In clinical contexts, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time, as recorded from multiple electrodes placed on the scalp.
The AE-918P is an 8 channel digital Electroencephalography (EEG) that connects to a Nihon Kohden patient monitor. It receives EEG data from patients and digitizes the signals, the waveforms and analysis are displayed on a Nihon Kohden Patient Monitor.
The AE-918P is contained in a small enclosure that contains the EEG amplifier and digital circuitry. This enclosure is mounted to the bottom of the patient monitor and connects to the patient monitor through the multilink cable.
Indications for Use
The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor.
The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, % Theta, % Alpha, % Beta, % Gamma, Abs Delta, Abs Theta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform.
The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.
The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home under direct supervision of a medical professional.
AE-918P Neuro Unit
5
Comparison to Predicate Devices
The following table compares the technological aspects of the new device with its predicate device (see Table 2). The intended use comparison is given in the conclusion section.
| Aspect | AE-918P
New Device | EEG-1200A (K#080546)
Configuration with standard JE-921A
Junction Box |
|------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Number of Channels | 8 | 32 |
| Input Impedance | 15 M ohm at 10Hz | 100 M ohm |
| Calibration Check | Step square 50 uV | Step square or Sine wave
2 to 1000 uV (9 steps) |
| Impedance Check | All inputs with Screen | All inputs with Screen
and Input box readout |
| Common-Mode
Rejection Ratio
(CMRR) | 110 dB or more (in
isolation mode)
60 dB or more (in
balance mode) | 105 dB or more |
| Noise Level | 1/20) | 50 or 60 Hz (rejection
ratio > 1/25) |
| ECG Filter | None | Standard |
| Sensitivity | OFF, 1 to 200 uV/mm
(14 steps) | OFF, 1 to 200 uV/mm
(15 steps)
DC: OFF, 10 to 200
mV/mm (10 steps) |
| A-D Conversion | 16 bits | 16 bits |
| Sampling | All channels
200 Hz (A-D
Conversion: 4 kHz) | All channels
100, 200, 500, 1000 Hz |
| Display | N/A | 1600 x 1200 |
| Resolution/Channels | | 64 + Mark Channel |
| Communication | Serial interface | Analog Input/Output,
Networking, Modem |
| Aspect | AE-918P | EEG-1200A (K#080546) |
| | New Device | Configuration with
standard JE-921A
Junction Box |
| Power | +12V+/- 5% 500 mA or
less
+5V+/- 5% 100 mA or
less | 120 V +/- 10%
50 / 60 Hz
750 VA |
| Operating Environment | Temperature: 10 to 40
degree C
Humidity: 30 to 90 % | Temperature: 10 to 35
degree C
Humidity: 30 to 80 % |
| Trend parameter | DSA
aEEG
FFT power
FFT power ratio | DSA
aEEG
FFT power
FFT power ratio |
| Number of trends | 8 | More than 8 |
| Number of trend
windows | 1 | 2 |
| Time interval of trends | N/A | 1 minute/page to 24 hours
/page
1 cm/hour to 60 cm/hour |
| Annotation list | No | Annotation list |
| Annotation trend | No | Annotation trend |
| MDF (Median
Frequency) | Yes | No |
| TP (Total Power Value) | Yes | No |
| aEEG | Yes | No |
Table 2 Technological Comparison to Predicate
6
Performance Testing
The AE-918P was subjected to safety and performance testing procedures. The AE-918P has undergone validation and verification testing to ensure conformance to all design requirements. Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of EEG trends. These tests verified that the device performed within specifications.
No Clinical testing was required
Testing of the Nihon Kohden AE-918P Neuro Unit was performed in compliance with Nihon Kohden Corporation design control process. Testing to the following standards was done. (See Table 3):
Table 3 Medical Electrical Equipment
IEC 60601-1 Part1: General requirements for safety 1998-12
IEC 60601-1, Amendment 1 Part 1: General Requirements for safety, Amendment 1,
7
1991-11
IEC 60601-1, Amendment 2 Part 1: General Requirements for safety, Amendment 2, 1995-03
IEC 60601-1-2 2nd edition Part 1-2: General requirements for safety - Collateral standard. Electromagnetic compatibility, 2001-09
IEC 60601-1-2 2nd edition, Part 1-2: General requirements for safety - Collateral Amendment 1 standard. Electromagnetic compatibility. Amendment 1, 2004-09
IEC 60601-2-26 Part 2-26: Particular Requirements for the safety of electroencephalograph 2002-11
Electrodes used as accessories with the device are the same as those of the predicate device and have previously been testing for biocompatibility for a surface contacting device of prolonged duration according to ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
Conclusion:
Based on the comparison information in the technical comparison chart above and confirmed by verification/validation testing in compliance with the Design Control requirements, the AE-918P was shown to be equivalent in safety and effectiveness to the main predicate device EEG-1200A.
The intended use of AE-918P Neuro unit is different from the predicate (EEG-1200A, K080546) because it is a simplified version of the EEG-1200A. thus with a subset of the intended use. The AE-918 has only 8 channels of EEG and used mainly for monitoring brain activity on a patient monitor. The EEG-1200 has up to 256 channels of EEG and can also be used for monitoring brain activity but has additional intended uses such as sleep studies. The technology and materials of the AE-918 are the same as used in the EEG-1200A. The other differences are covered by other predicates as shown in Table 1.