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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nihon Kohden JE-120A Electrode Junction Box for EEG-1200A, based on the provided document:

This 510(k) pertains to a Special 510(k) Notification for a device modification, focusing on substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are primarily related to meeting performance specifications and regulatory standards to demonstrate that the new device is as safe and effective as the predicate. The "study" here refers to the testing performed to show compliance with these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of technical characteristics between the new device (JE-120A) and the predicate devices (JE-212A/JE-921A). The "acceptance criteria" are implied by the values provided for the predicate devices, and the "reported device performance" is the value for the new device. The goal is to show the new device either meets or exceeds the predicate's performance, or that any differences do not raise new questions of safety or effectiveness.

Characteristic	Predicate JE-212A + Accessories (e.g., JE-225AK/226AK/227AK+QI-122A)	Predicate JE-921A (K#050833)	New Device JE-120A+JE-125AK(JE-225AK)/JE-226AK/JE-227AK/JE-228AK+QI-123A	Acceptance Criteria (Implied from Predicate)	Reported Device Performance (JE-120A)
Product used with	Electroencephalograph EEG-1200A K#080546	Electroencephalograph EEG-1200A K#080546	Electroencephalograph EEG-1200A K#080546	Must be compatible with EEG-1200A	Compatible with EEG-1200A
Intended Use	Electrode junction box for EEG	Electrode junction box for EEG/PSG	Electrode junction box for EEG/PSG	Equivalent to predicate's intended use	Equivalent to predicate's intended use
Measurement parameters	EEG	EEG, ECG, EMG, EOG, respiration, SpO₂, and CO₂	EEG, ECG, EMG, EOG, SpO₂, and CO₂	Same or expanded measurement parameters	Same as JE-921A
Number of input terminals	192 (EEG only)	25 (general)	256 (general)	At least 192 (EEG); 25 (general)	256 (general)
EEG input terminals	192	14	4 (JE-125AK)	Up to 192	Up to 256 (via accessories)
Multi-purpose input terminals	0	3	0	Not applicable (difference noted in document)	0
Bipolar input terminals	0	4	16	At least 0	16
Respiration input terminals	16	Input impedance 200M ohm	Input impedance 200M ohm	16 (for respiration)	16 (for respiration)
Input impedance	200M ohm	Less than 1.5 micro Vp-p	Less than 1.5 micro Vp-p	At least 100M ohm	200M ohm
Noise	Less than 1.5 micro Vp-p	More than 105dB	More than 110dB	Less than or equal to 1.5 micro Vp-p	Less than 1.5 micro Vp-p
Rejection ratio	More than 110dB	0.08Hz (TC 2 seconds)	0.016Hz(TC 10 seconds) or 0.08Hz (TC 2 seconds)	At least 105dB	More than 110dB
Low cut filter	0.016Hz (TC 10 seconds) or 0.08Hz (TC 2 seconds)	300Hz (-18dB/oct)	3000Hz (-18dB/oct)	Same or improved filter characteristics	0.016Hz or 0.08Hz
High cut filter	3000Hz (-18dB/oct.)	Yes	Yes	Same or improved filter characteristics	3000Hz (-18dB/oct)
Electrode impedance check	Yes	16 bit (97nV/LSB)	16 bit (97nV/LSB) or 16 bit (388nV/LSB)	Yes	Yes
A/D resolution	16 bits (97nV/LSB)	1000Hz	10000Hz	Equivalent or higher resolution	16 bits (97nV/LSB) or (388nV/LSB)
Maximum Sampling frequency	10000Hz	None	10000Hz	Equivalent or higher sampling frequency	10000Hz
SpO₂ input	None	SpO₂ adapter is connected to this unit directly.	SpO₂ adapter is connected to this unit directly.	SpO₂ input capability (if applicable)	Directly connected
EtCo2 input	None	EtCo2 adaptor is connected to this unit directly.	EtCo2 adaptor is connected to this unit directly.	EtCo2 input capability (if applicable)	Directly connected
Body position sensor	None	DC input terminals	None	Not applicable (difference noted in document)	None
Mini electrode junction box	Option	Option	Option	Option available	Option available
Interface with EEG	Ethernet	USB	Ethernet	Ethernet or USB	Ethernet
Safety	Class I, Type BF	Class I, Type BF	Class I, Type BF	Compliant with Class I, Type BF	Class I, Type BF

Note: The document implies acceptance criteria by comparing the new device's specifications to those of the predicate devices. The new device is generally shown to be equivalent or to offer improvements (e.g., more channels, higher sampling frequency) without raising new safety/effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly mention a "test set" in the context of patient data or clinical trials for evaluating diagnostic accuracy or performance like an AI algorithm would. This is a 510(k) for a hardware component (electrode junction box) of an EEG system.

The testing conducted was primarily engineering verification and validation of the device's hardware, software, and compliance with standards. Therefore, the "sample size" would refer to the number of units tested, the number of software modules, or test cases, not patient data.

Sample Size: Not applicable in the context of patient data. The testing involved multiple system components and software units.
Data Provenance: Not applicable in the context of patient data. The testing was internally conducted by Nihon Kohden Corporation. The reports listed (e.g., A100-000336B, A152-005167, A275-000544, etc.) are internal technical reports from the design control process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This type of information is relevant for studies evaluating diagnostic performance (e.g., an AI algorithm's ability to classify images). For this device, "ground truth" refers to the expected performance characteristics based on engineering specifications and regulatory standards. The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists at Nihon Kohden Corporation, who conduct and review the testing.

4. Adjudication Method for the Test Set

Not applicable for this type of device submission. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where disagreement among human readers or evaluators needs to be resolved to establish a definitive ground truth for an outcome. Here, performance is verified against predefined technical specifications and standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a hardware component (electrode junction box) for an EEG system, not an AI-powered diagnostic tool requiring human reader studies to assess improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an electrode junction box, a hardware component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on:

Engineering Specifications: Designed performance parameters (e.g., input impedance, noise levels, frequency response, channel count).
Predicate Device Performance: Performance data from the existing, legally marketed predicate devices (EEG-1200A with JE-212A / JE-921A) serves as a benchmark for substantial equivalence.
Voluntary Industrial Standards: Compliance with recognized medical electrical equipment safety and performance standards (e.g., IEC 60601-1 series, EN 60601 series, CAN/CSA-C22.2 series).
User Needs/Functional Requirements: Verification that the device meets its intended functional requirements as defined by Nihon Kohden (Report # A100-000336B).

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI algorithm, there is no training set or corresponding ground truth establishment process in this context.

Summary

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Special 510(k) Notif JE-120A Electrode Junction Box for EEG-1200A

MAR 2 2 2012

510(k) Summary
Company Name:	Nihon Kohden Corporation90 Icon StreetFoothill 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 StreetFoothill Ranch, CA 92610
	Steve GeerdesDirector Quality Assurance and Regulatory AffairsPhone: (949) 580-1555 Ext. 3325Fax:(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

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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

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-1200AK#080546	Electroencephalograph EEG-1200AK#080546	Electroencephalograph EEG-1200AK#080546
Intended Use	Electrode junction box for EEG	Electrode junction box for EEG/PSG	Electrode junction box for EEG/PSG
Measurementparameters	EEG	EEG, ECG, EMG, EOG, respiration,SpO₂and 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 inputterminals		25	256
EEG input terminals	192	14	4 (JE-125AK)
Multi-purpose inputterminals	0	3	0
Bipolar input terminals	0	4	16
Respiration inputterminals	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 2seconds)
Rejection ratio	0.016Hz(TC 10 seconds) or 0.08Hz (TC 2seconds)	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 impedancecheck	16 bits (97nV/LSB)	1000Hz	10000Hz
A/D resolution	10000Hz
Maximum Samplingfrequency
SpO₂ input	Electrode impedance check	None	10000Hz	SpO₂ adapter is connected tothis unit directly.	SpO₂ adapter is connected to this unitdirectly.
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 IDegree of protection against electric shock: Type BF	Type of protection against electrical shock: Class IDegree of protection against electric shock: Type BF	Type of protection against electrical shock: Class IDegree of protection against electric shock: Type BF

4.0 Data Summary

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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 andhumidity, 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 (includingpreliminary review andvalidation forimprovement)	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

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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

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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.

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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.

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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

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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:

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

Page 1 of /

Regulation Number and Section

§ 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).