(153 days)
K#050833
No
The summary describes a standard digital EEG system with data acquisition, digitization, and display capabilities. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is intended for diagnosis and recording of physiological signals, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides data that "may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis."
No
The device description explicitly lists multiple hardware components including a main unit, electrode junction box, PC Unit, and Isolation Unit, in addition to the 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 records and displays physiological signals directly from the patient's body (cerebral and extracerebral activity) using electrodes. It does not analyze samples taken from the body.
- The intended use describes recording, measuring, and displaying activity for EEG and Sleep Studies. This is a direct measurement of electrical activity within the body, not an analysis of a biological sample.
- The device description details the components for signal acquisition and processing from the patient. It doesn't mention any components for handling or analyzing biological specimens.
Therefore, the EEG-1200A series Neurofax falls under the category of a medical device that directly interacts with the patient to acquire physiological data, rather than an IVD device that analyzes samples from the patient.
N/A
Intended Use / Indications for Use
The EEG-1200A series Nerurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. This data may be used by the clinician in sleep disorders, 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 (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The EEG-1200A with JE-120A is a digital EEG based on a minimum of a 32-bit computer with a filing function. The device uses Windows Graphic User Interface, receives physiological signals (up to 256 channels with JE-120 electrode junction box) from patients and digitizes the signals, the application of the software reproduces the waveforms, The EEG-1200A with JE-120A consists of a main unit, electrode junction box (head box), PC Unit, Isolation Unit and System Programs. The electrode junction box, monitor, keyboard and mouse connect to the computer. The computer and control panel connect to the main unit. Components requiring AC power plug into the main unit's isolated power supply. The main unit plugs into a hospital grade AC power source. All components fit onto a portable cart. A stand is also available for the electrode junction box. Patient data is stored to hard drive or other commercially available digital storage media. Inputs for Sp02 and EtC02 are available.
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)
Testing of the Nihon Kohden EEG-1200ASystem with The JE-120A was performed in compliance with Nihon Kohden Corporation design control process. Testing included: User needs/Functional, Chassis, Labeling, Operating environment (temperature and humidity, EMC and EMI), Storage environment, Condition for transport, Risk analysis (including preliminary review and validation for improvement), Software unit test (JE-120A Software), Software unit test (QI-123A/124A Software), Software unit test (EEG-1200 Input module), Software integration test (JE-120A Software), Software integration test (QI-123A/124A Software), and Software integration test (EEG-1200 Input module). All tests were accepted.
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.
K#050833
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
Special 510(k) Notif JE-120A Electrode Junction Box for EEG-1200A
MAR 2 2 2012
510(k) Summary | |
---|---|
Company Name: | Nihon Kohden Corporation |
90 Icon Street | |
Foothill Ranch, CA 92610 | |
Device Name: | Nihon Kohden JE-120A Electrode Junction Box for EEG-1200A |
510(k) Sponsor, | |
Contact: | Nihon Kohden America, Inc. |
90 Icon Street | |
Foothill Ranch, CA 92610 | |
Steve Geerdes | |
Director Quality Assurance and Regulatory Affairs | |
Phone: (949) 580-1555 Ext. 3325 | |
Fax: | |
(949) 580-1550 | |
Summary Date: | 9/26/2011 |
Common Name: | Electroencephalograph amplifier (EEG Amplifier) |
Classification Names:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electroencephalograph . | 882.1400 GWQ | |
---|---|---|
Predicate Device(s):
Nihon Kohden EEG-1200A | K080546 |
---|---|
------------------------ | --------- |
1.0 Description of Device
The EEG-1200A with JE-120A is a digital EEG based on a minimum of a 32-bit computer with a filing function. The device uses Windows Graphic User Interface, receives physiological signals (up to 256 channels with JE-120 electrode junction box) from patients and digitizes the signals, the application of the software reproduces the waveforms, The EEG-1200A with JE-120A consists of a main unit, electrode junction box (head box), PC Unit, Isolation Unit and System Programs. The electrode junction box, monitor, keyboard and mouse connect to the computer. The computer and control panel connect to the main unit. Components requiring AC power plug into the main unit's isolated power supply. The main unit plugs into a hospital grade AC power
1
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
source. All components fit onto a portable cart. A stand is also available for the electrode junction box. Patient data is stored to hard drive or other commercially available digital storage media. Inputs for Sp02 and EtC02 are available.
2.0 Intended Use of Device
The EEG-1200A series Nerurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. This data may be used by the clinician in sleep disorders, 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.
3.0 Technical Characteristics
The new JE-120A Multi Channel Electrode Junction Box is the successor of the previous JE-212A, cleared with EEG-1200A, The JE-120A allows amplifying the EEG signal up to 256 channels, while the predicate JE-212A has up to 192 channels. The EEG-1200A with JE-120A also has inputs for SpO2 and EtCo2 which is the same as the technology found in Nihon Kohden's JE-921A
The product is controlled by the software installed on the EEG-1200 A series electroencephalograph (EEG).
Predicate Device | Predicate Device | New Device | |
---|---|---|---|
Electrode Junction Box | Electrode Junction Box | Electrode Junction Box | |
JE-212A+JE-225AK/226AK/227AK+QI- | |||
122A | JE-921A | ||
(K#050833) | JE-120A+JE-125AK(JE-225AK)/226AK/ | ||
227AK/228AK+QI-123A | |||
Product used with | Electroencephalograph EEG-1200A | ||
K#080546 | Electroencephalograph EEG-1200A | ||
K#080546 | Electroencephalograph EEG-1200A | ||
K#080546 | |||
Intended Use | Electrode junction box for EEG | Electrode junction box for EEG/PSG | Electrode junction box for EEG/PSG |
Measurement | |||
parameters | EEG | EEG, ECG, EMG, EOG, respiration, | |
SpO₂ | |||
and CO₂ | EEG, ECG, EMG, EOG, SpO₂ and CO₂ | ||
Specification |
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·
Special 510(k) Notification JE-120A Electrode Junction Box for EEG-1200A
| Number of input
terminals | 25 | 256 | |||||
---|---|---|---|---|---|---|---|
EEG input terminals | 192 | 14 | 4 (JE-125AK) | ||||
Multi-purpose input | |||||||
terminals | 0 | 3 | 0 | ||||
Bipolar input terminals | 0 | 4 | 16 | ||||
Respiration input | |||||||
terminals | 16 | 100M ohm | 200M ohm | ||||
DC input terminals | 200M ohm | Less than 1.5 micro Vp-p | Less than 1.5 micro Vp-p | ||||
Input impedance | Less than 1.5 micro Vp-p | More than 105dB | More than 110dB | ||||
Noise | More than 110dB | 0.08Hz (TC 2 seconds) | 0.016Hz(TC 10 seconds) or 0.08Hz (TC 2 | ||||
seconds) | |||||||
Rejection ratio | 0.016Hz(TC 10 seconds) or 0.08Hz (TC 2 | ||||||
seconds) | 300Hz (-18dB/oct) | 3000Hz (-18dB/oct) | |||||
Low cut filter | 3000Hz (-18dB/oct.) | Yes | Yes | ||||
High cut filter | Yes | 16 bit (97nV/LSB) | 16 bit (97nV/LSB) or 16 bit (388nV/LSB) | ||||
Electrode impedance | |||||||
check | 16 bits (97nV/LSB) | 1000Hz | 10000Hz | ||||
A/D resolution | 10000Hz | ||||||
Maximum Sampling | |||||||
frequency | |||||||
SpO₂ input | Electrode impedance check | None | 10000Hz | SpO₂ adapter is connected to | |||
this unit directly. | SpO₂ adapter is connected to this unit | ||||||
directly. | |||||||
A/D resolution | |||||||
Maximum frequency | Sampling | ||||||
SpO2 input | None | SpO₂ adapter is connected to this unit directly. | SpO₂ adapter is connected to this unit directly. | ||||
EtCo2 input | None | EtCo2 adaptor is connected to this unit directly. | EtCo2 adaptor is connected to this unit directly. | ||||
Body position sensor | None | DC input terminals | None | ||||
Mini electrode junction box | Option | Option | Option | ||||
Interface with EEG | Ethernet | USB | Ethernet | ||||
Safety | Type of protection against electrical shock: Class I | ||||||
Degree of protection against electric shock: Type BF | Type of protection against electrical shock: Class I | ||||||
Degree of protection against electric shock: Type BF | Type of protection against electrical shock: Class I | ||||||
Degree of protection against electric shock: Type BF |
:
4.0 Data Summary
.
3
i
Testing of the Nihon Kohden EEG-1200ASystem with The JE-120A was performed in compliance with Nihon Kohden Corporation design control process. Testing included:
1. User needs/Functional | Accepted | Report # A100-000336B |
---|---|---|
2. Chassis | Accepted | Report # A152-005167 |
3. Labeling | Accepted | Report # A152-005167 |
4. Operating environment, | ||
temperature and | ||
humidity, EMC and EMI | Accepted | Report # A152-005138 |
5. Storage environment | Accepted | Report # A152-005138 |
6. Condition for transport | Accepted | Report # A152-005138 |
7. Risk analysis (including | ||
preliminary review and | ||
validation for | ||
improvement) | Accepted | Risk Analysis Table: 0704-905679B |
Software unit test | ||
(JE-120A Software) | Accepted | Report # A275-000544 |
Software unit test | ||
(QI-123A/124A Software) | Accepted | Report # A275-000546 |
Software unit test | ||
(EEG-1200 Input module) | Accepted | Report # A275-000546 |
Software integration test | ||
(JE-120A Software) | Accepted | Report # A276-001026 |
Software integration test | ||
(QI-123A/124A Software) | Accepted | Report # A276-001028 |
Software integration test | ||
(EEG-1200 Input module) | Accepted | A Report # 276-001030 |
4
The device is in compliance with the following voluntary industrial standards:
Medical Electrical Equipment
Par1: General requirements for safety 1988 IEC 60601-1 IEC 60601-1, Amendment 1 Part 1: General Requirements for safety, Amendment 1, 1991
IEC 60601-1, Amendment 2 Part 1: General Requirements for safety, Amendment 2, ਹਰੇਰੇਟ
IEC 60601-1-2-40 * Part 2-40: Particular Requirements for the safety of electromyographs and evoked response equipment, 1998
IEC 60601-1-1 200 edition: Part 1-1: General requirements for safety – Collateral standard
Safety requirements for medical electrical systems, 2000 IEC 60601-1-2 200 edition: Medical electrical equipment- Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility, 2001
EN 60601-1: 1990 Equivalent to IEC 60601-1: 1998*
EN 60601-1 Amendment 1 Medical equipment general requirements for safety, 1 ਰੇਰੇ 3
EN 60601-1 Amendment 2 Medical equipment general requirements for safety, 1995
EN 60601-1-1: 2001 Equivalent to IEC 60601-1:2001
EN 60601-1-2:2001 Electromagnetic compatibility requirement test CAN/CSA-C22.2 No. 601.1-M90 Medical electrical equipment, Part 1: General requirements for safety.
CAN/CSA-C22.2 No. 601.1S1-94 Supplement No. 1-94 to CAN/CSA-C22.2 No. 601-1-M90 Medical Equipment- Part 1:General requirements for safety.
CAN/CSA-C22.2 No. 60601-1-1-02 Medical electrical equipment, Part 1-1: General requirements for safety- Collateral: Safety requirements for medical electrical systems, 2006
CAN/CSA-C22.2 No. 60601-2-40-01 Medical electrical equipment, Part 2-40: Particular requirements for safety of electromyographs and evoked response equipment (adopted 60601-2-40: 1998
CAN/CSA-C22.2 No. 601.1B-90 Amendment 2 to CAN/CSA-C22.2 No. 601.1-M90 Medical equipment Part 1: General requirements for safety: 2002
5
5.0 Conclusions
The substantial equivalence of the Nihon Kohden EEG-1200A with JE-120A 256 channel amplifier was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Nihon Kohden EEG-1200A with JE-120A 256 channel amplifier is equivalent to the predicate device Nihon Kohden EEG-1200A cleared with JE-212A 196 channel amplifier. The JE-212 with optional accessories JE-215A, JE-216A, and JE-217A mini electrode junction boxes allow up to 192 channels of amplification in 64 channel increments. The JE-120A with optional accessories JE-225A, JE-227A, and JE-228A mini electrode junction boxes allow up to 256 channels of amplification in 64 channel increments. The JE-225, 226, and 227, Are the same technology as JE-215,216, and 217, the only difference is the input connector is a slightly different configuration. The addition of the JE-228 is what allows the JE-120A to have up to 256 channels. The EEG-1200A with JE-120A also has inputs for SpO2 and EtCo2 which is the same as the technology found in Nihon Kohden's JE-921A. Validation was performed to ensure no new questions of safety or effectiveness are raised.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 2 2012
Nihon Kohden America, Inc. c/o Mr. Steve Geerdes Director of Regulatory Affairs and Quality Assurance 90 Icon Street Foothill Ranch, CA 92610
Re: K113117
Trade/Device Name: Nihon Kohden JE-120A Multi Electrode Junction Box for EEG-1200A Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: February 14, 2012 Received: February 22, 2012
Dear Mr. Geerdes:
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.
7
Page 2 - Mr. Steve Geerdes
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
E.G. Smith
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Form
K113117 510(k) Number (if known):
Nihon Kohden EEG-1200A with JE-120A 256 channel Device Name: amplifier
Indications for Use:
The EEG-1200A series Nerurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. This data may be used by the clinician in sleep disorders, 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use - (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dan Arch
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) K113117
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