(220 days)
No
The summary describes a system for measuring and displaying various physiological signals (EEG, EP, EMG, SpO2, ETCO2, temperature, nerve conduction time) and providing stimulation. There is no mention of AI, ML, or any advanced analytical techniques beyond basic signal processing and display. The focus is on data acquisition, stimulation, and presentation of raw or processed physiological data.
No
The device is primarily intended for monitoring, recording, and displaying bioelectric signals, as well as providing stimulation for diagnostic purposes and brain mapping during procedures, rather than directly treating a disease or condition. While it aids in diagnosis and assessment during treatment, its primary function is not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction." Additionally, it measures and displays various physiological signals (EP, EEG, EMG, nerve conduction time, SpO2, EtCO2, skin temperature) to "provide health care professionals with information to help assess a patient's neurological status," which is a diagnostic purpose.
No
The device description explicitly states that the system consists of a main unit, amp unit, breakout box, stimulation pods, and a computer with specific software, along with various standard and optional hardware accessories like cables, connectors, and sensors. This indicates it is a hardware system with accompanying software, not a software-only device.
Based on the provided information, the Neuromaster G1 MEE 2000 Neural Function Measuring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Neuromaster G1 MEE 2000 Function: The Neuromaster G1 MEE 2000 directly measures and monitors bioelectric signals (EEG, EMG, EP), nerve conduction, and physiological parameters (SpO2, EtCO2, skin temperature) from the patient's body. It also uses stimulation applied directly to the patient.
The device's function is focused on in vivo (within the living body) measurements and stimulation, not the analysis of in vitro (outside the living body) specimens.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GWF, IKN, ETN, GWO, JXE, GZO, GWF, GWJ
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.
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)
- 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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sensory and motor pathways, brain, peripheral nerve, distal portion of extremities
Indicated Patient Age Range
any patient as determined by the medical professional including adults and children of all ages.
Intended User / Care Setting
medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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.
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.
K051178, K962455, K040358, K050798, K061173, K053363, K850342, K071969, K083124, K110410, K111647, K112718, K120397
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.
K050798, K1110410, K12097, K071969, K110410, K120397, K962455, K083124, K111647, K112718
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
§ 882.1870 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).
0
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
1
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
2
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)
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.
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."
3
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.
· 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 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."
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."
4
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.
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."
5
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 Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo, Japan 161-8560 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Initial Importer | Nihon Kohden America
15353 Barranca Parkway
Irvine, CA |
| Contact Person: | Ms. Natalie J. Kennel
Consultant
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego, CA 92129 USA
Phone: (858) 705-0350
Fax: (858) 764-9739
Email: NKennel@njkconsulting.com |
Date 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 |
6
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 Function | |
| Measuring System | Nihon Kohden America, Inc | |
| K962455 | Cadwell Cascade | Cadwell Laboratories |
| K040358 | XLTEK | Excel Tech LTD |
| K050798 & | ||
| K061173 | Eclipse Neurological Workstation | Formerly Axon Systems, Inc. Now |
| Medtronic 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:
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
7
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.
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)
8
- 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
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.
9
· 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.
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.
10
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 | Nihon Kohden's model number MEE-1000 is
intended for medical purposes to measure,
monitor, record and display the bioelectric
signals produced by muscles (EMG), to
stimulate peripheral nerves and to monitor,
record and display the electrical activities
produced by nerves to aid clinicians in the
diagnosis and prognosis of neuromuscular
disease. The device monitors
electric/auditory/visual evoked potential,
EEG and EMG. The device is also 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. The device may use
electrical stimulus, visual stimulus, or sound
stimulus for use in evoked response
measurements (EP). Continuous and/or
periodic measurements of evoked potential
activities are displayed and stored. The
device applies an electrical stimulus to a
patient thru 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. The device | The subject device has the same
intended use as the main predicate
device. The indications for use for the
MEE2000 include two aspects that are
covered by additional reference
predicate devices: One is the inclusion
of SpO2 and EtCO2 measurements
which is also included in the Eclipse
Neurological Workstation by Axon
(K050798). The second is the
inclusion of nerve stimulator at low
output for surgical procedures and
braining mapping during treatment of
patients with seizure disorders and at
high output to be 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. This second indication
for use is covered by another reference
predicate, MS120BK Electric
Stimulator (K1110410). The
MS120BK Electric stimulator was
cleared to connect to the MEE1000
through its amplifier. In the subject
device the capability is included. |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| Indications for Use,
con't | 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 | may be used to determine autonomic
responses as psychological indicators by
measuring the electrical resistance of the skin
and the tissue path between two electrodes
applied to the skin. 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). The
acquired waveforms are displayed in
cascaded format and measurement data may
be displayed on the trendgraph with
waveforms annotations (events). The
acquired waveforms with the measurement
data can be saved in a large capacity storage
media. 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. | See above |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| Indications for Use,
con't | 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,
end-tidal 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 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. | See above | See above |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| Warnings/
Contraindications | Items related to off label use or misuse.
Items related to design and indicated use
limitations such as, not for use in the
presence of flammable anesthetics or in
conjunction with defibrillation equipment
Warnings regarding use of paralyzing agents
and surgical severing of nerves
Contraindication regarding use of TcMEP | Items related to off label use or misuse. Items
related to design and indicated use
limitations such as, not for use in the
presence of flammable anesthetics or in
conjunction with defibrillation equipment | Most warnings and precautions are the
same as MEE1000
Contraindication& Warnings same as
Eclipse (K050798) |
| Intended Use Patient
Population | The system is available for use on any
patient as determined by the medical
professional including adults and children of
all ages. | The device is available for use on any patient
as determined by the medical professional
including adults and children | No difference |
| General System
Approach | Computer based equipment with dedicated
hardware peripherals/components | Computer based equipment with dedicated
hardware peripherals/components | The specific peripherals/components
are more compact for customer
convenience |
| Input Boxes (Breakout
boxes) | 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 (The
MEE2000 has 4 stimulation pods
which are for both normal stimulation
and low level stimulation whereas the
MEE1000 has 4 stimulation pods for
normal stimulation and 2 other
stimulation pods for low level
stimulation.) |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| TcMEP control Box | 1 | Option (SEN-4100A, MS-120Bk) | Built-in function in ME2000, see
SEN-4100A (K071969), MS120BK
(K110410) |
| Foot switch | Available | None | Foot switch for hands free use
increases usability. |
| Computer Hardware/Software | | | |
| Operation System | WIN 7 Professional 32bit | WIN XP Pro | Depends on the PC (currently
available computers) |
| Memory | 4+ GB | 1 GB RAM | Depends on the PC (currently
available 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 (currently
available computers) |
| Storage capacity | 250 + GB (7200 rpm) | 40GB hard drive minimum | Depends on the PC (currently
available computers) |
| Amplifiers | | | |
| Number of Channels | 32 channels | 16 or 32 channels | Two models are not needed. 16
channel is covered with 32 channel
device. NVM5 (K112718) has 32
channels. |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| Maximum number of
connectable breakout
boxes (maximum total
number 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 | =±950mV | > 450mV | High depolarization voltage is
required for waveform quality
improvement |
| Other Physiological Monitoring | | | |
| Vital sign | Temperature, SpO2, CO2 | Temperature | New customer requested functionality
of SpO2 & CO2 measurements.
Additional reference predicate, Eclipse
Neurological Workstation, K050798,
has this functionality incorporated into
a system with the intended use as the
subject device |
| Vital sign measurement
range | Temperature: 0 to 45 °C
SpO2: 0 to 100%SpO2
CO2: 0 to 13.3 kPa (0 to 100 mmHg) | Temperature: 0 to 45 °C | New customer requested functionality
of SpO2 & CO2 measurements.
Additional reference predicate, Eclipse
Neurological Workstation, K050798,
has this functionality incorporated into
a system with the intended use as the
subject device |
| Averagers | | | |
| A/D Converter | 18 bits (16- bit for stored data) | 16 bits | Higher resolution is required by
customers |
| Conversion Speed | 5 µs/channel max. | Same | No difference |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| EP Waveforms:
Analysis time base: | 0.2 ms/div to 1 s/div | EP/EMG: 5 ms/div to 1 s/div
EEG: Same | New customer requested feature of
longer 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 50
mV/div | |
| Monitor Time Base or
Display 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 kHz
EEG waveform: 100, 200, 500 Hz, 1, 2 kHz | EP/EMG: 5 ms/div to 5 s/div
EEG: Same | Expressed differently. New customer
request 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 additional
trigger modes . |
| Trigger wave mode: | Single, Train, Train series (Multi train,
Number of train: 2 to 7) | Single , Train | Single, Double, Train series (Multi
train. Number of train 1 to 10) MEB-
2300A (K120397) |
| Number of Averages | 1 to 9999 | Same | No difference |
| Artifact Reject Inhibit
Range | ±1 to ±5 div or OFF | Same | No difference |
| Display | | | |
| Number of Waveform
Traces | EP: 100,000/ch | 10,000/ch | New customer requested feature to
offer additional number of waveform
traces per change |
| Waveform Display
Modes | Monitor, Stimulate, Average | Monitor, Sweep, Analysis | Terminology difference only |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference 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 options
increase customer options and
improve visual quality of information
display |
| Stimulator Common Functions | | | |
| Stimulus Rates | 0.1 Hz to 50 Hz | 0.1 Hz to 50 Hz | No difference |
| Stimulation Delay
Time | 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 TcMEP
output | 2 for high or low output, 1 for TcMEP output
(option) | TcMEP covered by MB-120BK
(K110410) |
| Number of Outputs
(Maximum total
number 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 was
requested 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 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| Stimulus Intensity | High output: 0 to 100 mA / 0 to 300V
Low output: 0 to 15 mA / 0 to 100 V
TcMEP: 0 to 250 mA / 0 to 1000 V | High output: 0 to 100 mA / 0-300V
Low output: 0 to 10 mA / 0 to 30V or 0 to 15
mA(MS-120BK) by option
TcMEP: 10 to 1000 V (SEN-4100A),
0 to
200 mA (MS-120BK) by option | New functionality for low output to
go to 100 V and TcMEP at 250 mA
TcMEP
Cadwell Cascade (K962455) and
Nerve Integrity Monitor 3.0
(K083124) have voltage to 100V for
low output. C2 Nerve Monitor System
(K111647) has 250 mA for TcMEP. |
| Stimulus Pulse
Duration | 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 to
be consistent with the 50 mJ/pulse
(with 1 kΩ load) requirement
specified in the IEC standard |
| Safety Limitation Notes | The following settings are not available.
Stimulation rate of more than 1 Hz for the
TcMEP output
Train numbers of more than 9 for the
TcMEP output
Alternating mode for the TcMEP output
Output of more than 15 mA for the Low
output
Monophasic mode for the Low output | See Additional reference predicates | The output is limited to 15 mA for the
Low output in the US to be aligned to
the MS-120BK predicate. |
| Auditory Stimulators | | | |
| Output Type | Earphones, Headphones | Headphones | Earphones option increase usability. |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference 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 White
Noise Masking | 0 to -50 dB, or OFF | 0 to -40 dB, or OFF | Lower masking noise option is
customer 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 tone
burst | 0 to 100 cycles | 0 to 1000 ms | Cycle setting ability improves
usability, change of units only |
| Rise/Fall Time of tone
burst | 1 to 100 cycles | 0.1 to 10 ms | Cycle setting ability improves
usability, change of units only |
| | | Visual Stimulators | |
| Stimulus Modes | Pattern Reversal, LED Flash, External
Visual Stimulation | Same | No difference |
| Patterns | Checkerboard | Checkerboard, Horizontal Bars, Vertical
Bars | Removed Horizontal Bars, Vertical
Bars based on customer input for
usability |
| Number of Horizontal
Divisions | 4, 8, 16, 32, 64, 128 | Same | No difference |
| LED Flash Pulse
Duration | 1 to 50 ms | 10 ms | New functionality of adjustable pulse
duration |
| Recorder | | | |
| Recording Mode | Hard Copy, Trend | Same | No difference |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| External Input
Analog 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 of
several 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) mm
2.0 kg
32 channels: 265 (W) x 210 (H) x 84 (D) mm
2.7 kg | New device is smaller and lighter than
32 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 new
functionality. This does not raise any
new issues of safety and has been
tested to safety standards |
| Inrush current | 30 A max/115 Vac, 60 A max/230 Vac
(EMI capacitors excluded, cold start at
25°C) | Not determined | Note that this was not measured with
the MEE1000 predicate because it was
required 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 change
based on PC) |
| Operating Humidity | 30 to 80% (non-condensing) | 20 to 80% | Depend on the PC (small change
based on PC |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon Kohden
(K051178) | Comparison and additional
reference predicates |
| Storage Humidity | 10 to 95% | 20 to 80% | Increased convenience for product
storage |
| Operating Atmospheric
Pressure | 10 to 35 °C (50 - 95°F) | Same | No difference |
| Storage Atmospheric
Pressure | 700 to 1060 hPa | Same | No difference |
| | | Protocols Available | |
| Electric evoked
potential | SEP (somatosensory evoked potential)
SSEP (short-latency somatosensory
evoked potential)
SCEP (Spinal cord evoked potential)
(This is referred to as ESCP in clinical
protocol used for preoperative examination.)
ELECTRIC (customizable protocol) | SEP (somatosensory evoked potential)
SSEP (short-latency somatosensory
evoked potential)
ESCP (Evoked Spinal Cord Potential)
ELECTRIC (customizable protocol) | The only difference between "SCEP"
and "ESCP" is terminology. The
function is as the same as the
predicate. |
| Auditory evoked
potential | 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) is
added because it is one of common
examinations techniques used for
monitoring of auditory evoked
potential and is available in MEB-
2300A (K120397). |
| Visual evoked potential | Pattern-VEP (pattern reversal visual evoked
potential)
Goggle-VEP (LED goggle visual evoked
potential)
Flash-VEP (Flash visual evoked potential)
ERG (Electroretinography)
VISUAL (customizable protocol) | PR-VEP (pattern reversal visual evoked
potential)
LED-VEP (LED visual evoked potential)
EXT-VEP (External flash stimulator visual
evoked potential)
ERG (Electroretinography)
VISUAL (customizable protocol) | For Pattern-VEP, Goggle-VEP, Flash-
VEP, the only difference from the
predicate device is terminology. The
function is as the same as the
predicate. |
| Characteristic | Neuromaster G1 MEE2000 System
(this submission) | Neuromaster MEE1000 System
Nihon 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-ABR
Trend-SEP
Trend-VEP
CSA | 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
Neuromaster G1 MEE2000 510(k)
Section 5 – Page 6 of 28
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| Specification/Property | Subject Device (K142624) | Predicate Device
MEE-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 Device
MS-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, the
energy per pulse is limited to
maximum 50mJ. |
| Maximum Voltage (V @ 1kΩ load) | 250 (V) | 200 (V) | This is calculated by the maximum
current 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 2
ms |
| Energy per Pulse (mJ @ 1kΩ load) | 50 (mJ) | 40 (mJ) | The maximum safe energy
recommendation of 50 mJ is put
forth by IEC 60601-2-40. |
| Parameter | Subject Device (K142624) | Predicate Device
MS-120B (K110410) | Comments |
| Maximum RMS Current (mA) | 7.1 (mA) | 6.3 (mA) | This is calculated by the maximum
current 250mA. |
| Minimum Surface Area Electrode ( $cm^2$ ) | 0.5 ( $cm^2$ )
surface electrode
NM-413B (NKC) | 0.5 ( $cm^2$ )
surface electrode
NM-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 maximum
current 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 maximum
current 250mA. |
| Interface | | | |
| Trigger Input | 2 | 2 | Same |
| Trigger Output | 2 | 2 | Same |
| Foot Switch Control | Sequence Start/Stop | Sequence Start/Stop | Same |
Neuromaster G1 MEE2000 510(k)
Section 5 - Page 20 of 28
25
26
| Parameter | Subject Device (K142624) | Predicate Device
SEN-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 @ 1kΩ
load) | 7.1 (mA) | 7.1 (mA) | Same |
| Minimum Surface Area Electrode (cm²) | 0.5 (cm²)
surface electrode
NM-413B (NKC) | 0.5 (cm²)
surface electrode
NM-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
Neuromaster G1 MEE2000 510(k)
Section 5 - Page 22 of 28
27
| Parameter | Subject Device (K142624) | Predicate Device
SEN-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 Device
MS-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 requested
Impedances (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 Device
MS-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) | 0.04cm²
Strip and grid electrode
TS04R-SP10X-000 (Ad-Tech) | 0.04cm²
Strip and grid electrode
TS04R-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 kΩ
load) | 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 |
Neuromaster G1 MEE2000 510(k)
Section 5 – Page 23 of 28
28
Section 5 – Page 24 of 28
29
| Parameter | Subject Device (K142624) | Predicate Device
MEE-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. Rectangular
monophasic) | 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 electrode
NE-136B (NKC) | 0.5 (cm²)
Disc electrode
NE-136B (NKC) | Same |
| Maximum RMS Current Density
(mA/cm²) | 6.4 (mA/cm²) | 6.4 (mA/cm²) | Same |
30
| Parameter | Subject Device (K142624) | Predicate Device
MEE-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 |
31
| Table 9 Substantial Equivalence Table for New Electrodes |
|---|
| ---------------------------------------------------------- |
| 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 2 | ||
| instead 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 in |
| packaging | |||
| Patient Contact | Yes: Gel part | Yes: Gel part | No difference |
| Single | |||
| Use/Reusable | Single use | Single use | No difference |
| Provided Sterile | No | No | No difference |
| End user | |||
| sterilization? | No | No | No difference |
| Color additives | Used in Connector part. No patient contact | Used in Connector part. No patient contact | No difference |
| Electrode | |||
| withstand | |||
| Voltage | within +/-30mV | within +/-30mV | No difference |
| Electrode | |||
| impedance | 10Hz, 3kΩ or less | 10Hz, 3kΩ or less | No difference |
| Offset fluctuation | |||
| and 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 of |
| NM-316Y (gel) is | |||
| identical to predicate | |||
| NM- 317Y3 so | |||
| biocompatibility | |||
| certificate 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/AgCl | |||
| carbon, 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/AgCl | |||
| carbon, Electrode lead: Copper (core), PVC (covering) | |||
| Connector: Phosphor bronze (core) PP (housing) | |||
32
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.