The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.

· TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

· Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

• SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used. oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, endtidal carbon dioxide of respiratory gas information is automatically measured and displayed.

• Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.

· Remote reader – The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children of all ages.

Device Description

The Neuromaster G1 MEE2000 Neural Function Measuring System is a compact and multi-functional system for continuous monitoring of brain and neural pathways intraoperatively and in critical care areas. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of the extremities, SpO2 and ETCO2. The system also measures and displays nerve conduction time by applying a stimulus to a patient's peripheral nerve. The system includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The system uses electrical stimulus, visual stimulus, or sound stimulus in evoked responses measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The system applies an electrical stimulus to a patient through skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting light pattern or to apply a brief light stimulus for use in evoked response measurements or electroencephalogram activation. The system may measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The system can be used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

The system can be connected to SpO2 and ETCO2 sensors to display the patient's oxygen saturation values as measured by pulse oximetry and CO2 values respectively throughout the procedure.

The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trend graph with waveform annotations (events). The acquired waveforms with the measurement data can be saved to a large capacity storage media. The data can be printed directly on paper, printed to portable document format (pdf), and/or archived to other locations.

The Neuromaster G1 MEE2000 System consists of at minimum a main unit (DC-200B), an amp unit (JB-232B), one breakout box (JB-210B), four stimulation pods [JS-201B(A), JS-202B (B), JS-203B (C), JS-204B (D)], and a computer (CC-201BK) with specific software. There are several standard and optional accessories such as cables, connectors, SpO2 probes, ETCO2 sensors, and various types of electrodes and leads.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Neuromaster G1 MEE2000 Neural Function Measuring System, as derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria and explicitly defining the new device's performance against them. Instead, the performance characteristics of the Neuromaster G1 MEE2000 System are presented in comparison to its predicate device (Neuromaster MEE1000 System) and other reference predicates. The "acceptance criteria" here are implicitly the performance specifications of the predicate devices, which the new device aims to meet or exceed where noted.

I will present a selection of key characteristics to illustrate this comparison format. Please note that the document contains a very extensive table (Table 3) outlining numerous characteristics; this is a summary of some of the most relevant ones to demonstrate the device's technical specifications and how they align with or improve upon predicates.

Table: Acceptance Criteria (Predicate Performance) and Reported Device Performance (Neuromaster G1 MEE2000)

Characteristic	Acceptance Criteria (Predicate MEE1000 Performance)	Reported Device Performance (Neuromaster G1 MEE2000)	Comparison/Comments
Indications for Use	Same as predicate MEE1000, with additions	Monitor, record, display bioelectric signals (EP, EEG, EMG), skin temperature, SpO2, ETCO2; nerve stimulator for surgical procedures, brain mapping, intraoperative diagnosis.	The subject device includes the same intended use as the main predicate device. Additional functions like SpO2, EtCO2 measurements, and enhanced nerve stimulation (TcMEP) are covered by other reference predicates.
Noise	<3µV p-p (1Hz-3kHz)	<4.5µV p-p or <0.6µVrms (at 1Hz-3kHz input shorted)	Slightly higher noise than main predicate but lower than other reference predicates.
Low-cut Filter	EP/EMG: 0.08 Hz to 500Hz at 6 dB/octave	EP/ free-run waveform: 0.08 Hz to 3 kHz at 6 dB/octave	New customer-requested feature of 3kHz filter; does not raise new safety/effectiveness issues.
High-cut Filter	EP/EMG: 10 Hz to 500Hz at 12 dB/octave	EP/ free-run waveform: 10 Hz to 3 kHz at 12 dB/octave	New customer-requested feature of 3kHz filter.
A/D Converter	16 bits	18 bits (16-bit for stored data)	Higher resolution, described as a customer requirement.
EP Waveforms: Analysis time base	EP/EMG: 5 ms/div to 1 s/div	0.2 ms/div to 1 s/div	New customer-requested feature of longer time interval.
Contralateral White Noise Masking (Auditory)	0 to -40 dB, or OFF	0 to -50 dB, or OFF	Lower masking noise option, a customer request.
Maximum Current (TcMEP - Constant Current)	200 mA	250 mA	Increased, but energy per pulse is limited to max 50mJ (IEC 60601-2-40 recommendation).
Energy per Pulse (TcMEP - Constant Current)	40 mJ	50 mJ	Aligns with the maximum safe energy recommendation of 50 mJ from IEC 60601-2-40.
Line Voltage	117 V AC	100 to 240 V AC	To support worldwide use.

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

The document explicitly states: "No animal or clinical studies were necessary for Neuromaster G1 MEE2000 Neural Function Measuring System." This indicates that there was no "test set" in the traditional sense of human or animal subjects for performance evaluation for the 510(k) submission. The data provenance is therefore not applicable in this context as no clinical data was generated for this submission. The evaluation was primarily based on engineering verification and validation testing, and comparison to predicate devices' established performance.

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

Not applicable, as no clinical studies with human or animal test sets were conducted. The "ground truth" for the device's technical specifications was established through engineering design, calculations, and adherence to relevant industry standards (e.g., IEC 60601-1, IEC 60601-2-40), rather than expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies requiring ground truth adjudication from experts were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. The Neuromaster G1 MEE2000 is a neural function measuring system, not an AI-assisted diagnostic or interpretation tool that would involve human readers interpreting cases. It monitors, records, and displays bioelectric signals, but does not provide automated diagnoses or interpretations that would be subject to MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a measurement and monitoring system, designed for use by medical personnel. It is not an "algorithm-only" device that operates without human interaction or interpretation of the displayed data.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is intrinsically linked to its technical specifications and safety standards. This includes:

Engineering Specifications: Adherence to design parameters for signal amplitude, noise levels, filter characteristics, stimulation intensity, etc.
International Standards: Compliance with recognized standards such as IEC 60601-1 (electrical safety), IEC 60601-2-40 (electrical medical equipment for electromyographs and evoked response equipment), and 21 CFR Part 898 (Performance Standard for Electrode Lead Wires and Patient Cables).
Predicate Device Performance: The established operating characteristics and proven safety and effectiveness of the legally marketed predicate devices (primarily Neuromaster MEE1000 System), which the new device demonstrates substantial equivalence to.

8. The Sample Size for the Training Set

Not applicable. As indicated in point 2, no animal or clinical studies were necessary. This device is not an AI/machine learning device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other, creating a sense of depth and unity. The profiles are rendered in a simple, abstract manner.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2015

Nihon Kohden Corporation % Natalie Kennel Regulatory Affairs Consultant NJK & Associates Inc. 13721 Via Tres Vista San Diego, California 92129

Re: K142624

Trade/Device Name: Neuromaster G1 Mee2000 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, IKN, ETN, GWO, JXE, GZO, GWF, and GWJ Dated: March 20, 2015 Received: March 25, 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

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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 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" (21 CFR 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,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration

Indications for Use

510(k) Number (if known) K142624 Page 1 of 3

Device Name

Neuromaster G1 MEE2000 Neural Function Measuring System

Indications for Use (Describe)

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142624 page 2 of 3

Device Name

Neuromaster G1 MEE2000 Neural Function Measuring System

Indications for Use (Describe)

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· SpO2 - When the SpO2 adapter and toe probe for SpO2 measurement are used, oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, end-tidal carbon dioxide of respiratory gas information is automatically measured and displayed.

· Skin temperature - When the skin temperature measurement is used, skin temperature information is automatically measured and displayed.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVIGES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142624 page 3 of 3

Device Name

Neuromaster G1 MEE2000 Neural Function Measuring System

Indications for Use (Describe)

· Remote reader - The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The system is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The system is available for use on any patient as determined by the medical professional including adults and children of all ages.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/0 description: The image shows the logo for NIHON KOHDEN, a medical device company. The logo consists of a blue abstract symbol on the left and the company name "NIHON KOHDEN" in blue capital letters on the right. Below the logo, the text "510(k) Summary" is written in a bold, serif font.

Sponsor:	Nihon Kohden Corporation1-31-4 Nishiochiai, Shinjuku-KuTokyo, Japan 161-8560
Initial Importer	Nihon Kohden America15353 Barranca ParkwayIrvine, CA
Contact Person:	Ms. Natalie J. KennelConsultantNJK & Associates, Inc.13721 Via Tres VistaSan Diego, CA 92129 USAPhone: (858) 705-0350Fax: (858) 764-9739Email: NKennel@njkconsulting.com

Date Prepared: April 22, 2015

DEVICE INFORMATION

Proprietary Name:	Neuromaster G1 MEE2000 System
Common Name:	Neural Function Measuring System
Classification:	Class II (Performance Standards)
Device Product Code & Classification Panel:
Panel: Neurology
21 CFR 890.1375 product code IKN
21 CFR 874.1820 product code ETN
21 CFR 882.1400 product code GWQ
21 CFR 882.1550 product code JXE
21 CFR 882.1540 product code GZO
21 CFR 882.1870 product code GWF
21 CFR 882.1890 product code GWJ

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Predicate Devices:

The predicate devices are listed in Table 1. The main predicate device is the Neuromaster MEE1000 System and the other two are additional reference predicates. None of the predicates have been subject to design recalls.

510(k)	Product	510(k) Holder
K051178	Neuromaster MEE1000 Neural FunctionMeasuring System	Nihon Kohden America, Inc
K962455	Cadwell Cascade	Cadwell Laboratories
K040358	XLTEK	Excel Tech LTD
K050798 &K061173	Eclipse Neurological Workstation	Formerly Axon Systems, Inc. NowMedtronic Xomed
K053363(K850342)	Subdural Electrodes	AD-Tech
K071969	SEN-4100A Electric Stimulator	Nihon Kohden Corporation
K083124	Nerve Integrity Monitor 3.0	Medtronic Xomed
K110410	MS-120BK Electrical Stimulator	Nihon Kohden America, Inc.
K111647	C2 Nerve Monitor System	Inomed
K112718	NVM5 System	NuVasive
K120397	MEB-2300A	Nihon Kohden America, Inc.

Table 1 Table of Predicates

Product Description:

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brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

The system can be connected to SpO2 and ETCO2 sensors to display the patient's oxygen saturation values as measured by pulse oximetry and CO2 values respectively throughout the procedure.

A complete list of all modalities/software functions of the Neuromaster G1 MEE2000 System is given in Table 2.

Table 2 MEE2000 Modalities/Software Functions

Electrical Evoked Potentials ●
- o Somatosensory Evoked Potentials (SEP)
- Short-Latency Somatosensory Evoked Potential (SSEP) O
- Spinal cord evoked potentials (SCEP) (or ESCP: evoked spinal cord O potential)
- Electric Customizable о
Auditory Evoked Potentials ●
- Auditory Brainstem Response (ABR) O
- Middle Latency Response (MLR) O
- Slow Vertex Response (SVR) O
- Electrocochleography (EcochG) O
- Auditory Customizable O
Visual Evoked Potentials ●
- Pattern Reversal Visual Evoked Potential (PR-VEP) O
- O Goggle Visual Evoked Potential (LED goggle -VEP)
- Flash Visual Evoked Potential (Flash-VEP) O
- Electroretinography (ERG) O
- о Visual Customizable
Electromyography (EMG) ●
- o Free-run EMG
Electroencephalography (EEG) ●
- Electroencephalography (EEG) o
- Density Spectral Array (DSA) о
- Compressed Spectral Array (CSA) o
Nerve Conduction
- o Motor Nerve Conduction studies (MCS)

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Sensory Nerve Conduction studies (SCS) o
Trend Monitoring
- Trend-ABR O
- Trend-SEP O
- Trend-VEP O
- Trend-DSA O
- o Trend-CSA
Motor Evoked Potential (MEP) ●
- Transcranial Motor Evoked Potential (TcMEP) o
- o Cortical Motor Evoked Potential (CoMEP)
Remote Monitoring ●

Indications for Use

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

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• SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used. oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, endtidal carbon dioxide of respiratory gas information is automatically measured and displayed.

• Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.

· Remote reader – The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children of all ages.

Comparison to Predicate Devices

Table 3 contains a comparison of the Neuromaster G1 MEE2000 System to its main predicate device, the Neuromaster MEE1000 System and additional "reference" predicates to support certain aspects in this comparison. Table 4, Table 5, Table 6, Table 7, and Table 8 have been included to completely describe the substantial equivalence comparison of the detailed functional aspects of the Neuromaster G1 MEE2000 to its predicates. Table 9 contains a detailed comparison of the new Neuromaster G1 MEE2000 NCS Electrode to the predicate electrode to support the physical, patient contact and material aspects in this comparison.

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Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Indications for Use	The Neuromaster G1 MEE 2000 NeuralFunction Measuring System is intended tomonitor, record, and display the bioelectricsignals produced by sensory and motorpathways in the operating room, criticalcare, and other areas where continuousmonitoring is needed. The system measuresand displays electric/auditory/visual evokedpotential (EP), electroencephalography(EEG), and electromyography (EMG), skintemperature of distal portion of extremities,SpO2, and ETCO2 to provide health careprofessionals with information to help assessa patient's neurological status. The systemis used as a nerve stimulator for surgicalprocedures and brain mapping duringtreatment of patients with seizure disordersand used for the intraoperative diagnosis ofacute dysfunction in corticospinal axonalconduction brought about by mechanicaltrauma (traction, shearing, laceration, orcompression) or vascular insufficiency.• EEG - The device may also measure andrecord the electrical activities of the patient'sbrain obtained by placing two or moreelectrodes on the head (EEG).• EP-Electrical/ Auditory/ Visual -Continuous and/or periodic measurements ofevoked potential activities are displayed andstored. The device applies an electricalstimulus to a patient through commercially	Nihon Kohden's model number MEE-1000 isintended for medical purposes to measure,monitor, record and display the bioelectricsignals produced by muscles (EMG), tostimulate peripheral nerves and to monitor,record and display the electrical activitiesproduced by nerves to aid clinicians in thediagnosis and prognosis of neuromusculardisease. The device monitorselectric/auditory/visual evoked potential,EEG and EMG. The device is also intendedto measure and display nerve conductiontime by applying a stimulus to a patient'speripheral nerve. This device includes thestimulator and the electronic processingequipment for measuring and displaying thenerve conduction time. The device may useelectrical stimulus, visual stimulus, or soundstimulus for use in evoked responsemeasurements (EP). Continuous and/orperiodic measurements of evoked potentialactivities are displayed and stored. Thedevice applies an electrical stimulus to apatient thru commercially available skinelectrodes for the purpose of measuring theevoked response. The photic stimulator isused to generate and display a shiftingpattern or to apply a brief light stimulus to apatient's eye and the auditory stimulatorproduces a sound stimulus for use in evokedresponse measurements orelectroencephalogram activation. The device	The subject device has the sameintended use as the main predicatedevice. The indications for use for theMEE2000 include two aspects that arecovered by additional referencepredicate devices: One is the inclusionof SpO2 and EtCO2 measurementswhich is also included in the EclipseNeurological Workstation by Axon(K050798). The second is theinclusion of nerve stimulator at lowoutput for surgical procedures andbraining mapping during treatment ofpatients with seizure disorders and athigh output to be used for theintraoperative diagnosis of acutedysfunction in corticospinal axonalconduction brought about bymechanical trauma (traction, shearing,laceration, or compression) or vascularinsufficiency. This second indicationfor use is covered by another referencepredicate, MS120BK ElectricStimulator (K1110410). TheMS120BK Electric stimulator wascleared to connect to the MEE1000through its amplifier. In the subjectdevice the capability is included.
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Indications for Use,con't	available skin electrodes for the purpose ofmeasuring the evoked response. The photicstimulator is used to generate and display ashifting pattern or to apply a brief lightstimulus to a patient's eye and the auditorystimulator produces a sound stimulus for usein evoked response measurements orelectroencephalogram activation.• Free Run EMG - The Free Run EMGfunction identifies spontaneous EMGactivity of nerves by continually displayinga live stream waveform of any mechanicallyinduced myotome contractions.• CoMEP - Cortical stimulation techniquesfor cortical mapping are used at "LowOutput" for placement of electrodes duringsurgical procedures and for brain mappingduring treatment of patients with seizuredisorders.• TcMEP - Transcranial electricalstimulation techniques for motor evokedpotentials (TcMEP) are used at "TcMEPOutput" for the intraoperative diagnosis ofacute dysfunction in corticospinal axonalconduction brought about by mechanicaltrauma (traction, shearing, laceration, orcompression) or vascular insufficiency."• Nerve conduction study - The device isintended to measure and display nerveconduction time by applying a stimulus to apatient's peripheral nerve. This deviceincludes the stimulator and the electronic	may be used to determine autonomicresponses as psychological indicators bymeasuring the electrical resistance of the skinand the tissue path between two electrodesapplied to the skin. The device may alsomeasure and record the electrical activities ofthe patient's brain obtained by placing two ormore electrodes on the head (EEG). Theacquired waveforms are displayed incascaded format and measurement data maybe displayed on the trendgraph withwaveforms annotations (events). Theacquired waveforms with the measurementdata can be saved in a large capacity storagemedia. The device is intended for use bymedical personnel within a hospital,laboratory, clinic or nursing home setting oroutside of a medical facility under directsupervision of a medical professional. Thedevice is available for use on any patient asdetermined by the medical professionalincluding adults and children.	See above
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Indications for Use,con't	processing equipment for measuring anddisplaying the nerve conduction time.• SpO2 - When the SpO2 adapter andfinger and toe probe for SpO2 measurementare used, oxygen saturation information isautomatically measured and displayed.• EtCO2 - When the CO2 adapter andsensor for EtCO2 measurement are used,end-tidal carbon dioxide of respiratory gasinformation is automatically measured anddisplayed.• Skin temperature - When the skintemperature sensor for skin temperaturemeasurement is used, skin temperatureinformation is automatically measured anddisplayed.• Remote reader – The remote readerfunction provides real time remote access tothe system for a monitoring physicianoutside of the operating room.The system is intended for use by medicalpersonnel within a hospital, laboratory,clinic or nursing home setting or outside of amedical facility under direct supervision of amedical professional.The system is available for use on anypatient as determined by the medicalprofessional including adults and children ofall ages.	See above	See above
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Warnings/Contraindications	Items related to off label use or misuse.Items related to design and indicated uselimitations such as, not for use in thepresence of flammable anesthetics or inconjunction with defibrillation equipmentWarnings regarding use of paralyzing agentsand surgical severing of nervesContraindication regarding use of TcMEP	Items related to off label use or misuse. Itemsrelated to design and indicated uselimitations such as, not for use in thepresence of flammable anesthetics or inconjunction with defibrillation equipment	Most warnings and precautions are thesame as MEE1000Contraindication& Warnings same asEclipse (K050798)
Intended Use PatientPopulation	The system is available for use on anypatient as determined by the medicalprofessional including adults and children ofall ages.	The device is available for use on any patientas determined by the medical professionalincluding adults and children	No difference
General SystemApproach	Computer based equipment with dedicatedhardware peripherals/components	Computer based equipment with dedicatedhardware peripherals/components	The specific peripherals/componentsare more compact for customerconvenience
Input Boxes (Breakoutboxes)	1, 2, 3 or 4 input boxes	1, 2 or 3 input boxes	Number of input pins is 1 higher,MEB-2300A (K12097).
Stimulation Pod	1, 2, 3 or 4 within low-level	1, 2, 3 or 4 and 1 or 2 at low-level	Number of units are reduced (TheMEE2000 has 4 stimulation podswhich are for both normal stimulationand low level stimulation whereas theMEE1000 has 4 stimulation pods fornormal stimulation and 2 otherstimulation pods for low levelstimulation.)
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
TcMEP control Box	1	Option (SEN-4100A, MS-120Bk)	Built-in function in ME2000, seeSEN-4100A (K071969), MS120BK(K110410)
Foot switch	Available	None	Foot switch for hands free useincreases usability.
Computer Hardware/Software
Operation System	WIN 7 Professional 32bit	WIN XP Pro	Depends on the PC (currentlyavailable computers)
Memory	4+ GB	1 GB RAM	Depends on the PC (currentlyavailable computers)
Network	10/100/1000 Mb/s Ethernet	Standard Ethernet interface	No difference
CPU	Core - i5, 2.0+ GHZ	Pentium M 760, 2.00 GHZ	Depends on the PC (currentlyavailable computers)
Storage capacity	250 + GB (7200 rpm)	40GB hard drive minimum	Depends on the PC (currentlyavailable computers)
Amplifiers
Number of Channels	32 channels	16 or 32 channels	Two models are not needed. 16channel is covered with 32 channeldevice. NVM5 (K112718) has 32channels.
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Maximum number ofconnectable breakoutboxes (maximum totalnumber of input jacks)	4(64)	4(64)	No difference
Input Impedance	>100 MΩ (Differential Mode)≥1000 MΩ (Common Mode)	>100 MΩ (Differential Mode)≥1000 MΩ (Common Mode)	No difference
Noise	<4.5µV p-p or <0.6µVrms ( at 1Hz-3kHzinput shorted )	<3µV p-p (1Hz-3kHz)	Subject device has slightly highernoise than main predicate but lowerthan other predicates including: Xltek(K040358), Eclipse (K050798),NVM5 (K112718).
Common ModeRejection Ratio(CMRR)	≥106 dB (Balanced mode)≥112 dB (Isolation mode)	≥106 dB (Balanced mode)≥112 dB (Isolation mode)	No difference
Sensitivity	EP/ free-run waveform: 0.05 to 500 µV/divand 1 to 50 mV/divEEG: 5 to 10000 µV/div	EP/EMG: 0.05 to 500 µV/div and 1 to 50mV/divEEG: 5 to 10000 µV/div	No difference (EMG and free runwaveform - different terminology forsame function)
Low-cut Filter	EP/ free-run waveform: 0.08 Hz to 3 kHz at6 dB/octaveEEG: 0.08 Hz to 159 Hz at 6 dB/octaveTime constant: 0.001, 0.003, 0.03, 0.1, 0.3,	EP/EMG: 0.08 Hz to 500Hz at 6 dB/octaveEEG: 0.08 Hz to 159 Hz at 6 dB/octave	New customer requested feature of3kHz filter. New filter does not raisenew issue of safety or effectiveness.MEB-2300A (K120397) has 3 kHzmaximum.
	High-cut Filter	EP/ free-run waveform: 10 Hz to 3 kHz at12 dB/octave, offEEG: 15 Hz to 300 Hz at 12 dB/octave
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Skin Electrode contactImpedance Check	2, 5, 10, 20, 50, 100, 200 kΩ indication	2, 5, 10, 20, 50, 100, 200 kΩ indication	No difference
Amplitude Calibration	1 div	10, 100 µV, 1, 10mV	Change of the expression.
AC Interface notchfilter	50 or 60 Hz or Comb filter(Rejection ratio: <1/20)	50 or 60 Hz	New customer requested feature ofComb filter. New filter does not raisenew issue of safety or effectiveness.
Electrode offsettolerance	>=±950mV	> 450mV	High depolarization voltage isrequired for waveform qualityimprovement
Other Physiological Monitoring
Vital sign	Temperature, SpO2, CO2	Temperature	New customer requested functionalityof SpO2 & CO2 measurements.Additional reference predicate, EclipseNeurological Workstation, K050798,has this functionality incorporated intoa system with the intended use as thesubject device
Vital sign measurementrange	Temperature: 0 to 45 °CSpO2: 0 to 100%SpO2CO2: 0 to 13.3 kPa (0 to 100 mmHg)	Temperature: 0 to 45 °C	New customer requested functionalityof SpO2 & CO2 measurements.Additional reference predicate, EclipseNeurological Workstation, K050798,has this functionality incorporated intoa system with the intended use as thesubject device
Averagers
A/D Converter	18 bits (16- bit for stored data)	16 bits	Higher resolution is required bycustomers
Conversion Speed	5 µs/channel max.	Same	No difference
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
EP Waveforms:Analysis time base:	0.2 ms/div to 1 s/div	EP/EMG: 5 ms/div to 1 s/divEEG: Same	New customer requested feature oflonger time interval
EP Waveform	EP waveform: 5 ms/div to 1 s/div	EP/EMG: 0.05 to 500 $\mu$ V/div and to 1 to 50mV/div
Monitor Time Base orDisplay time (for EEG)	Free-run waveforms: 5 ms/div to 5 s/div		No difference – different expression
	EEG waveforms: 2 to 60 s/page	EEG: 100, 200, 500, 1, 2, 3 kHz
Sampling frequency	Free-run waveforms: 100, 200, 500 Hz, 1, 2, 5 kHzEEG waveform: 100, 200, 500 Hz, 1, 2 kHz	EP/EMG: 5 ms/div to 5 s/divEEG: Same	Expressed differently. New customerrequest feature of shorter time interval
Time Base Modes	Individually selected for each channel	Same	No difference
Trigger Delay Time	-10 to +10 div in 1 div steps or 0 to 500 ms	-10 to +10 div in 1 div steps	New customer requested feature of"ms" unit step.
Trigger Modes	Recurrent, Single Stim, Signal, EXT1,EXT2, Shift, Multi train, MTS from Train 1	Recurrent, Single, Signal, EXT1, EXT2	New customer requested additionaltrigger modes .
Trigger wave mode:	Single, Train, Train series (Multi train,Number of train: 2 to 7)	Single , Train	Single, Double, Train series (Multitrain. Number of train 1 to 10) MEB-2300A (K120397)
Number of Averages	1 to 9999	Same	No difference
Artifact Reject InhibitRange	±1 to ±5 div or OFF	Same	No difference
Display
Number of WaveformTraces	EP: 100,000/ch	10,000/ch	New customer requested feature tooffer additional number of waveformtraces per change
Waveform DisplayModes	Monitor, Stimulate, Average	Monitor, Sweep, Analysis	Terminology difference only
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Cursors	2 horizontal, 2 vertical	2 horizontal, 2 vertical	No difference
Scale	5, 10, 15, 20 div	5, 10, 15, 20 div	No difference
Grid Display options	Broken line, Intersections, Vertical line,None	Line, Dot, OFF	Additional grid display optionsincrease customer options andimprove visual quality of informationdisplay
Stimulator Common Functions
Stimulus Rates	0.1 Hz to 50 Hz	0.1 Hz to 50 Hz	No difference
Stimulation DelayTime	0 to 10 seconds in 0.1 ms steps	0 to 10 seconds	No difference
External trigger signal	Amplitude: >4 V (polarity selectable)Duration: > 10 µs	Amplitude: >4 V (polarity selectable)Duration: > 10 µs	No difference
Trigger signal output	Amplitude: 5 V (within ±5%)Duration: 1, 5, 10 ms (within ±20%)	Amplitude: 5 V (within ±5%)Duration: 1, 5, 10 ms (within ±20%)	No difference
Electrical Stimulators
Output type	1 for high or low output, 1 for TcMEPoutput	2 for high or low output, 1 for TcMEP output(option)	TcMEP covered by MB-120BK(K110410)
Number of Outputs(Maximum totalnumber of outputs)	High: 8 (32)Low: 2 (8)TcMEP: 1 (8 jacks)	10 (High), 1 (Low)and more 10 (High), 1 (Low) by option	Maximum 32 high outputs wasrequested by customers.
Output mode	Constant current or constant voltage	See additional predicates	Constant current - MS-120B(K110410) or constant voltage- SEN-4100A (K07196)
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Stimulus Intensity	High output: 0 to 100 mA / 0 to 300VLow output: 0 to 15 mA / 0 to 100 VTcMEP: 0 to 250 mA / 0 to 1000 V	High output: 0 to 100 mA / 0-300VLow output: 0 to 10 mA / 0 to 30V or 0 to 15mA(MS-120BK) by optionTcMEP: 10 to 1000 V (SEN-4100A),0 to200 mA (MS-120BK) by option	New functionality for low output togo to 100 V and TcMEP at 250 mATcMEPCadwell Cascade (K962455) andNerve Integrity Monitor 3.0(K083124) have voltage to 100V forlow output. C2 Nerve Monitor System(K111647) has 250 mA for TcMEP.
Stimulus PulseDuration	0.05 to 1 ms	0.05 to 1 ms	No difference
Output polarity	Positive, Negative	Positive, Negative	No difference
Output phase	Monophasic, Biphasic, Alternating	Monophasic, Biphasic, Alternating	No difference
Safety Limitation	Less than 50mJ / pulse (with 1kΩ load)	Not applicable	This safety limitation was phrased tobe consistent with the 50 mJ/pulse(with 1 kΩ load) requirementspecified in the IEC standard
Safety Limitation Notes	The following settings are not available.Stimulation rate of more than 1 Hz for theTcMEP outputTrain numbers of more than 9 for theTcMEP outputAlternating mode for the TcMEP outputOutput of more than 15 mA for the LowoutputMonophasic mode for the Low output	See Additional reference predicates	The output is limited to 15 mA for theLow output in the US to be aligned tothe MS-120BK predicate.
Auditory Stimulators
Output Type	Earphones, Headphones	Headphones	Earphones option increase usability.
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Stimulus Waveform	Click, Tone Burst	Same	No difference
Stimulus Phase(polarity)	Condensation (positive), Rarefaction(negative), Alternating	Same	No difference
Stimulus Intensity	0 to 135 dB SPL	Same	No difference
Contralateral WhiteNoise Masking	0 to -50 dB, or OFF	0 to -40 dB, or OFF	Lower masking noise option iscustomer request
Click Pulse Duration	0.1 to 1 ms	Same	No difference
Tone Burst Frequency	50 Hz to 10 KHz	Same	No difference
Plateau Time of toneburst	0 to 100 cycles	0 to 1000 ms	Cycle setting ability improvesusability, change of units only
Rise/Fall Time of toneburst	1 to 100 cycles	0.1 to 10 ms	Cycle setting ability improvesusability, change of units only
		Visual Stimulators
Stimulus Modes	Pattern Reversal, LED Flash, ExternalVisual Stimulation	Same	No difference
Patterns	Checkerboard	Checkerboard, Horizontal Bars, VerticalBars	Removed Horizontal Bars, VerticalBars based on customer input forusability
Number of HorizontalDivisions	4, 8, 16, 32, 64, 128	Same	No difference
LED Flash PulseDuration	1 to 50 ms	10 ms	New functionality of adjustable pulseduration
Recorder
Recording Mode	Hard Copy, Trend	Same	No difference
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
External InputAnalog Input	1 V/div (8 channels, selectable)	1 V/div (8 channels, selectable)	No difference
Main Unit	400 (W) x 63 (H) x 315 (D) mm 4.0 kg	340 (W) x 41 (H) x 355 (D) mm 2.3 kg	Main unit is larger due to inclusion ofseveral other units.
Electrode Junction Box(Amp unit)	32 channels only: 250 (W) x 190 (H) x 75(D) mm 2.0 kg	16 channels :160 (W) x 210 (H) x 84 (D) mm2.0 kg32 channels: 265 (W) x 210 (H) x 84 (D) mm2.7 kg	New device is smaller and lighter than32 channel predicate
Power Unit	The Main Unit includes Power Unit.	Same	No difference
Line Voltage	100 to 240 V AC	117 V AC	To support use worldwide
Line Frequency	50/60 Hz	Same	No difference
Power Input	1000 VA (DC-200B)	Less than 75 VA	Power input to support different newfunctionality. This does not raise anynew issues of safety and has beentested to safety standards
Inrush current	30 A max/115 Vac, 60 A max/230 Vac(EMI capacitors excluded, cold start at25°C)	Not determined	Note that this was not measured withthe MEE1000 predicate because it wasrequired by IEC 60601-1 3rd edition.
Environment
Operating Temperature	10 to 35 °C (50 - 95°F)	Same	No difference
Storage Temperature	-20 to +60 °C (-4 to +140°F)	-20 to +65 °C	Depend on the PC (small changebased on PC)
Operating Humidity	30 to 80% (non-condensing)	20 to 80%	Depend on the PC (small changebased on PC
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additionalreference predicates
Storage Humidity	10 to 95%	20 to 80%	Increased convenience for productstorage
Operating AtmosphericPressure	10 to 35 °C (50 - 95°F)	Same	No difference
Storage AtmosphericPressure	700 to 1060 hPa	Same	No difference
		Protocols Available
Electric evokedpotential	SEP (somatosensory evoked potential)SSEP (short-latency somatosensoryevoked potential)SCEP (Spinal cord evoked potential)(This is referred to as ESCP in clinicalprotocol used for preoperative examination.)ELECTRIC (customizable protocol)	SEP (somatosensory evoked potential)SSEP (short-latency somatosensoryevoked potential)ESCP (Evoked Spinal Cord Potential)ELECTRIC (customizable protocol)	The only difference between "SCEP"and "ESCP" is terminology. Thefunction is as the same as thepredicate.
Auditory evokedpotential	ABR (auditory brainstem response)MLR (middle latency response)SVR (slow vertex response)EcochG (electrocochleography )AUDITORY (customizable protocol)	ABR (auditory brainstem response)MLR (middle latency response)SVR (slow vertex response)AUDITORY (customizable protocol)	EcochG (electrocochleography) isadded because it is one of commonexaminations techniques used formonitoring of auditory evokedpotential and is available in MEB-2300A (K120397).
Visual evoked potential	Pattern-VEP (pattern reversal visual evokedpotential)Goggle-VEP (LED goggle visual evokedpotential)Flash-VEP (Flash visual evoked potential)ERG (Electroretinography)VISUAL (customizable protocol)	PR-VEP (pattern reversal visual evokedpotential)LED-VEP (LED visual evoked potential)EXT-VEP (External flash stimulator visualevoked potential)ERG (Electroretinography)VISUAL (customizable protocol)	For Pattern-VEP, Goggle-VEP, Flash-VEP, the only difference from thepredicate device is terminology. Thefunction is as the same as thepredicate.
Characteristic	Neuromaster G1 MEE2000 System(this submission)	Neuromaster MEE1000 SystemNihon Kohden(K051178)	Comparison and additional reference predicates
EMG(electromyogram)	Free-run EMG	EMG (electromyogram)MUP (Motor unit action potential)	The only difference between “Free-run EMG” and “EMG” is terminology. The function is as the same as the predicate.Free-run EMG is referred to as “Free-run waveform” in the Operator’s Manual.
Nerve Conduction	MCS (motor nerve conduction studies)SCS (sensory nerve conduction studies)	MCS (motor nerve conduction)SCS (sensory nerve conduction)F-WAVE	MUP is removed from MEE-2000 because it is not necessary.F-wave is removed from MEE-2000 because of low frequency of use.
Autonomic Nervous System	None	SSR (Sympathetic skin response)	SSR is removed from MEE-2000 because of low frequency of use.
Trend Monitoring	Trendgraph (Trend ABR or/and SEP or/and VEP)Trend CSA/DSA	Trend-ABRTrend-SEPTrend-VEPCSA	DSA is added, which is different expression of CSA.
EEG	EEG (Electroencephalography)DSA (Density Spectral Array)CSA (Compressed Spectral Array)	EEG (Electroencephalography)CSA (Compressed Spectral Array)	DSA is added, which is different expression of CSA.
Motor Evoked Potential(MEP)	Transcranial Motor Evoked Potential (TcMEP)Cortical Motor Evoked Potential (CoMEP)	Optional unit	MS-120BK (K110410) for TcMEP (Constant Current) and CoMEP and SEN-4100A (K071969)
Remote Monitoring	Remote Reader	None	Remote reader function is available in NVM5 (K112718)

Table 3 Substantial Equivalence Table for Neuromaster G1 MEE2000 System

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Specification/Property	Subject Device (K142624)	Predicate DeviceMEE-1000A (K051178)	Comment
Purpose	Free-run waveform	Free-run waveform	Same
Audible EMG	Yes	Yes	Same
Automatic Muting During Artifact	No	No	Same

Table 4 EMG Predicate Comparison Table

Table 5 TcMEP (Constant Current) Predicate Comparison Table

Parameter	Subject Device (K142624)	Predicate DeviceMS-120B (K110410)	Comments
Purpose	TcMEP	TcMEP	Same
Stimulator Output
Constant Current/Constant Voltage	Constant Current	Constant Current	Same
Maximum Current (mA)	250 (mA)	200 (mA)	Even if 250mA is applied, theenergy per pulse is limited tomaximum 50mJ.
Maximum Voltage (V @ 1kΩ load)	250 (V)	200 (V)	This is calculated by the maximumcurrent 250mA.
Maximum Pulse Duration (ms)	1 (ms)	1 (ms)	Same
Waveform (ex. Rectangular monophasic)	Rectangular monophasic	Rectangular monophasic	Same
Output Frequency (Hz)	1 (Hz)	1 (Hz)	Same
Number of pulse trains	5	5	Same
Interpulse Interval (ms)	2 (ms)	1 (ms)	See SEN-41000A (K071969) for 2ms
Energy per Pulse (mJ @ 1kΩ load)	50 (mJ)	40 (mJ)	The maximum safe energyrecommendation of 50 mJ is putforth by IEC 60601-2-40.
Parameter	Subject Device (K142624)	Predicate DeviceMS-120B (K110410)	Comments
Maximum RMS Current (mA)	7.1 (mA)	6.3 (mA)	This is calculated by the maximumcurrent 250mA.
Minimum Surface Area Electrode ( $cm^2$ )	0.5 ( $cm^2$ )surface electrodeNM-413B (NKC)	0.5 ( $cm^2$ )surface electrodeNM-413B (NKC)	Same
Maximum RMS Current Density (mA/ $cm^2$ )	14.1 (mA/ $cm^2$ )	12.7 (mA/ $cm^2$ )	This is calculated by the maximumcurrent 250mA.
Maximum Charge Density ( $μC/cm^2$ )	Coulomb =Current x Time = 200 (uC)Charge Density=Coulomb / Area = 400 ( $μC/cm^2$ )	Coulomb =Current x Time = 200 (uC)Charge Density=Coulomb / Area = 400 ( $μC/cm^2$ )	Same
Maximum power density (W/ $cm^2$ @ 1 kΩ load)	W =Current x Voltage = 62.5 (W)Power Density =Watt / Area = 125 (W/ $cm^2$ )	W =Current x Voltage = 40 (W)Power Density =Watt / Area = 80 (W/ $cm^2$ )	This is calculated by the maximumcurrent 250mA.
Interface
Trigger Input	2	2	Same
Trigger Output	2	2	Same
Foot Switch Control	Sequence Start/Stop	Sequence Start/Stop	Same

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Parameter	Subject Device (K142624)	Predicate DeviceSEN-4100A (K071969)	Comments
Purpose		TcMEP
Stimulator Output
Constant Current/Constant Voltage	Constant Voltage	Constant Voltage	Same
Maximum Voltage (V)	1000 (V)	1000 (V)	Same
Maximum Current (mA @ 1kΩ load)	1000 (mA)	1000 (mA)	Same
Maximum Pulse Duration (ms)	0.05 (ms)	0.05 (ms)	Same
Waveform (ex. Rectangular monophasic)	Rectangular monophasic	Rectangular monophasic	Same
Output Frequency (Hz)	1 (Hz)	1 (Hz)	Same
Number of pulse trains	5	5	Same
Interpulse Interval (ms)	2 (ms)	2 (ms)	Same
Energy per Pulse (mJ @ 1kΩ load)	50 (mJ)	50 (mJ)	Same
Maximum RMS Current (mA @ 1kΩload)	7.1 (mA)	7.1 (mA)	Same
Minimum Surface Area Electrode (cm²)	0.5 (cm²)surface electrodeNM-413B (NKC)	0.5 (cm²)surface electrodeNM-413B (NKC)	Same
Maximum RMS Current Density(mA/cm² @ 1kΩ load)	14.1 (mA/cm²)	14.1 (mA/cm²)	Same
Maximum Charge Density (µC/cm² @1kΩ load)	Coulomb =Current x Time = 50 (uC)Charge Density=Coulomb / Area = 100 (µC/cm²)	Coulomb =Current x Time = 50 (uC)Charge Density=Coulomb / Area = 100 (µC/cm²)	Same

Table 6 TcMEP (Constant Voltage) Predicate Comparison Table

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Parameter	Subject Device (K142624)	Predicate DeviceSEN-4100A (K071969)	Comments
Maximum power density (W/cm² @ 1 kΩ load)	W =Current x Voltage = 1000 (W)Power Density =Watt / Area = 2000 (W/cm²)	W =Current x Voltage = 1000 (W)Power Density =Watt / Area = 2000 (W/cm²)	Same
Interface
Trigger Input	2	1	Same as MS-120BK (K110410),MEE-1000A (K051178)
Trigger Output	2	1	Same as MS-120BK (K110410),MEE-1000A (K051178)
Foot Switch Control	Sequence Start/Stop	Sequence Start/Stop	Same

Table 7 Electrical (Low) EP Predicate Comparison Table

Parameter	Subject Device (K142624)	Predicate DeviceMS-120B (K110410)	Comments
Purpose	Facial, CoMEP	Facial, CoMEP	Same
Stimulator Output
Constant Current/Constant Voltage	Constant Current	Constant Current	Same
Maximum Current (mA)	15 (mA)	15 (mA)	Same
Theoretical Max Voltage for System (V)	100 (V)	100 (V)	Same
Maximum Voltage at requestedImpedances (V @ 1kΩ load)	15 (V)	15 (V)	Same
Maximum Pulse Duration (ms)	0.3 (ms)	0.3 (ms)	Same
Waveform (ex. Rectangular monophasic)	Rectangular biphasic	Rectangular biphasic	Same
Parameter	Subject Device (K142624)	Predicate DeviceMS-120B (K110410)	Comments
Maximum Output Frequency (Hz)	50 (Hz)	50 (Hz)	Same
Energy per Pulse (mJ @ 1kΩ load)	0.07 (mJ)	0.07 (mJ)	Same
Maximum RMS Current (mA)	0.3 (mA)	0.3 (mA)	Same
Minimum Surface Area Electrode (cm²)	0.04cm²Strip and grid electrodeTS04R-SP10X-000 (Ad-Tech)	0.04cm²Strip and grid electrodeTS04R-SP10X-000 (Ad-Tech)	Same
Maximum RMS Current Density(mA/cm²)	6.5 (mA/cm²)	6.5 (mA/cm²)	Same
Maximum Charge Density (µC/cm²)	Coulomb =Current x Time = 4.5 (uC)Charge Density=Coulomb / Area = 113 (µC/cm²)	Coulomb =Current x Time = 4.5 (uC)Charge Density=Coulomb / Area = 113 (µC/cm²)	Same
Maximum power density (W/cm² @ 1 kΩload)	W =Current x Voltage = 0.23 (W)Power Density =Watt / Area = 5.63 (W/cm²)	W =Current x Voltage = 0.23 (W)Power Density =Watt / Area = 5.63 (W/cm²)	Same
Interface
Trigger Input	2	2	Same
Trigger Output	2	2	Same
Foot Switch Control	Sequence Start/Stop	Sequence Start/Stop	Same

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Parameter	Subject Device (K142624)	Predicate DeviceMEE-1000A (K051178)	Comments
Purpose	SSEP
Stimulator Output
Constant Current/Constant Voltage	Constant Current	Constant Current	Same
Maximum Current (mA)	100 (mA)	100 (mA)	Same
Theoretical Max Voltage for System(V)	300 (V)	300 (V)	Same
Voltage at requested Impedances (V @1kΩ load)	100 (V)	100 (V)	Same
Maximum Pulse Duration (ms)	1 (ms)	1 (ms)	Same
Waveform (ex. Rectangularmonophasic)	Rectangular Monophasic	Rectangular Monophasic	Same
Output Frequency (Hz)	50 (Hz)	50 (Hz)	Same
Energy per Pulse (mJ @ 1kΩ load)	10 (mJ)	10 (mJ)	Same
Maximum RMS Current (mA)	3.2 (mA)	3.2 (mA)	Same
Minimum Surface Area Electrode (cm²)	0.5 (cm²)Disc electrodeNE-136B (NKC)	0.5 (cm²)Disc electrodeNE-136B (NKC)	Same
Maximum RMS Current Density(mA/cm²)	6.4 (mA/cm²)	6.4 (mA/cm²)	Same

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Parameter	Subject Device (K142624)	Predicate DeviceMEE-1000A (K051178)	Comments
Maximum Charge Density(µC/cm²)	Coulomb =Current x Time = 100 (uC)Charge Density=Coulomb / Area = 200 (µC/cm²)	Coulomb =Current x Time = 100 (uC)Charge Density=Coulomb / Area = 200 (µC/cm²)	Same
Max Power Density (W/cm²)	W =Current x Voltage = 10 (W)Power Density =Watt / Area = 20 (W/cm²)	W =Current x Voltage = 10 (W)Power Density =Watt / Area = 20 (W/cm²)	Same
Interface
Trigger Input	2	2	Same
Trigger Output	2	2	Same
Foot Switch Control	Sequence Start/Stop	Sequence Start/Stop	Same

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Table 9 Substantial Equivalence Table for New Electrodes
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	MEE2000 NCS Electrodes (New in Submission)	Predicate NCS Electrode MEB-2300A (K120397)
Characteristic	NM-316Y	NM-317Y3	Comparison
Manufacturer	NKC	NKC	No difference
Description	2 x recording electrode (red)2 x recording electrode (black)1 x grounding electrode (green)	1 x recording electrode (red)1 x recording electrode (black)1 x grounding electrode (green)	Only available as 2instead of 1
Cable length	0.2m	0.2m	No difference
Quantity	50 (5 x 10 packages) (5 electrodes/sheet)	30 (3 x 10 packages) (3 electrodes/sheet)	Quantity differences inpackaging
Patient Contact	Yes: Gel part	Yes: Gel part	No difference
SingleUse/Reusable	Single use	Single use	No difference
Provided Sterile	No	No	No difference
End usersterilization?	No	No	No difference
Color additives	Used in Connector part. No patient contact	Used in Connector part. No patient contact	No difference
ElectrodewithstandVoltage	within +/-30mV	within +/-30mV	No difference
Electrodeimpedance	10Hz, 3kΩ or less	10Hz, 3kΩ or less	No difference
Offset fluctuationand internal noise	within +/-150μ(p-p)(5min)	within +/-150μ(p-p)(5min)	No difference
Material	Gel cover: paper, Tape: polyethylene	Gel cover &ID label: paper, Tape: polyethylene	Patient contact part ofNM-316Y (gel) isidentical to predicateNM- 317Y3 sobiocompatibilitycertificate provided
	Gel: Acrylic hydrophilic macromolecule, glycerin,sorbitol, water	Gel: Acrylic hydrophilic macromolecule, glycerin,sorbitol, water
	Label: polyester non-woven fabric tape, acrylic(adhesive), Electrode element: Ag/AgCl and Ag/AgClcarbon, Electrode lead: Copper (core), PVC (covering)Connector: Phosphor bronze (core) PP (housing)	Label: polyester non-woven fabric tape, acrylic(adhesive), Electrode element: Ag/AgCl and Ag/AgClcarbon, Electrode lead: Copper (core), PVC (covering)Connector: Phosphor bronze (core) PP (housing)

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None of the performance or technological differences between the Neuromaster G1 MEE2000 System and its predicates raise any new issues of safety and effectiveness.

Performance Testing

The Neuromaster G1 MEE2000 System has been subjected to design verification and validation testing for electrical safety, electromagnetic compatibility, software V & V , operational performance, usability, and operational and storage environmental performance. These tests verified and validated the proper operation of the system. Conformance to 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables was met with compliance to IEC 60601-1 3td edition clause 8.5.2.3.

Like its predicate, the Neuromaster G1 MEE2000 System is provided non-sterile and is not patient contacting. All patient contacting accessories but one electrode are previously cleared either Nihon Kohden products or other manufacturers' products so additional biocompatibility, shelf-life or if applicable sterilization was not necessary. A biocompatibility certificate was provided for the new electrode which was made of identical materials and process to a predicate.

No animal or clinical studies were necessary for Neuromaster G1 MEE2000 Neural Function Measuring System.

Conclusion:

The data and information provided in this submission support the conclusion that the Neuromaster G1 MEE2000 Neural Function Measuring System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).