MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
Device Facts
| Record ID | K120397 |
|---|---|
| Device Name | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM |
| Applicant | Nihon Kohden Corp. |
| Product Code | GWF · Neurology |
| Decision Date | Sep 19, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1870 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device 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 activity of the patient's brain obtained by placing two or more electrodes on the head (EEG). 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 may also be placed in the intensive care unit or operating room for continuous recording. The device is available for use on any patient as determined by the medical professional including adults and children.
Device Story
System acquires bioelectric signals (EMG, EEG, NCV, EP) via electrodes; utilizes electrical, visual, or auditory stimulators for evoked response testing. Main unit processes signals via pre-amplifiers, filters, and 18-bit ADC; controlled by PC-based software (Windows XP/7). Outputs displayed on monitor, printed, or stored in encrypted database. Used by clinicians in hospitals/clinics for neuromuscular diagnosis/prognosis. Benefits include precise nerve conduction measurement and continuous monitoring in ICU/OR settings.
Clinical Evidence
No clinical testing performed for this submission. Bench testing only.
Technological Characteristics
6 or 12 differential channels; 18-bit ADC; 200 MΩ input impedance; 106 dB CMRR. Includes pre-amplifier, low/high pass filters. Connectivity via PC (Windows XP/7). Stimulators: electrical (up to 200 mA), auditory, visual. Portable cart-mounted. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, and CAN/CSA standards.
Indications for Use
Indicated for adults and children requiring neuromuscular, nerve conduction, evoked response, autonomic, or EEG monitoring/recording for diagnosis and prognosis of neuromuscular disease. Used by medical personnel in hospitals, clinics, labs, nursing homes, ICUs, or ORs.
Regulatory Classification
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.
Predicate Devices
- MEB-2200A Neuropack Evoked Potential and EMG Measuring System (K991899)
Reference Devices
- NIM-Spine by Medtronic (K031510)
Related Devices
- K133517 — NEMUS 2 SYSTEM · Eb Neuro S.P.A. · Feb 26, 2014
- K120979 — CAREFUSION NICOLET EDX · Carefusion 209, Inc. · Apr 25, 2012
- K051178 — MEE-1000A NEUROMASTER · Nihon Kohden America, Inc. · Aug 17, 2005
- K991899 — NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES · Nihon Kohden America, Inc. · Sep 1, 1999
- K073415 — NEMUS SYSTEM; NEMUS PC PERIPHERAL · Eb Neuro S.P.A. · May 23, 2008
Submission Summary (Full Text)
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510(k) Summary
ﻦ
Special 510(k) Notification MEB-2300A Neuropack
K120397
| Company Name: | Nihon Kohden Corporation<br>90 Icon Street<br>Foothill Ranch, CA 92610 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Nihon Kohden MEB-2300A Neuropack Evoked Potential<br>and EMG Measuring System |
| 510(k) Sponsor, Contact: | Nihon Kohden America, Inc.<br>90 Icon Street<br>Foothill Ranch, CA 92610<br><br>Steve Geerdes<br>Director Quality Assurance and Regulatory Affairs<br>Phone: (949) 580-1555 Ext. 3325<br>Fax: (949) 580-1550 |
| Revised Summary Date: | 09/17/2012 |
Electroencephalograph amplifier (EEG Amplifier) Common Name:
# Classification Names:
| Stimulator, Electrical, Evoked Response | 882.1870 | GWF |
|-----------------------------------------|----------|-----|
|-----------------------------------------|----------|-----|
Predicate Device(s):
| MEB-2200A Neuropack Evoked Potential and<br>EMG Measuring System | K991899 |
|------------------------------------------------------------------|---------|
|------------------------------------------------------------------|---------|
#### Description of Device 1.0
The MEB-2200A Neuropack Evoked Potential and EMG Measuring System consists of a main acquisition unit, operation control panel, foot switch, electrode junction box (head box), electrical stimulation box and commercially available computer, monitor, printer, keyboard, and mouse. The device also includes optional visual, and auditory stimulators. The monitor, keyboard, and mouse connect to the computer. The computer, electrode junction box, electrical stimulation box, and control panel connect to the main unit. All
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components requiring AC power plug into the main unit's built-in, isolated power supply. The main unit plugs into a hospital grade AC power source. All components fit onto a portable cart. A stand is also available for the electrode junction box and electrical stimulation box. Patient data is stored to a encrypted database on the local hard drive or a remote server. The data can also be archived to other commercially available storage medias .
#### 2.0 Intended Use of Device
The Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device 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 activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
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 may also be placed in the intensive care unit or operating room for continuous recording.
The device is available for use on any patient as determined by the medical professional including adults and children.
#### 3.0 Technical Characteristics
Setup for the device is performed by a medical professional in the graphical user interface environment of Windows XP or Windows 7. The operator enters patient identification data and specifies the testing protocol. The testing protocol specifies amplifier, acquisition, stimulation, and special parameters for recording data. Recording electrodes and/or sensors are attached to the patient and connected to the corresponding jacks on the junction box. Stimulation electrodes and/or accessories may also be connected. Skin-electrode impedance check is performed from the electrode junction box or the computer software to verify electrode connection and confirm impedance levels for non-invasive recording electrodes. Stimulation is activated to the patient if specified in the protocol.
The device provides 6 or 12 differential channels. Each channel has a pre-amplifier, post-amplifier, low pass filter, and high pass filter. Analog signals from the electrodes and/or sensors are transmitted to a preamplifier for conditioning. The signal output is then fed to the analog to digital converter (ADC).
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The digitized electrophysiologic signals may be displayed on the monitor, printed, and/or stored to hard disk drives or other storage media. After completion of the study, the patient is disconnected from the device and medical professional prints and/or stores the data. The data can then be reviewed by a medical professional on the MEB-2300A/K system or another computer containing MEB-2300A/K review software.
#### 4.0 Data Summary
- . Non-clinical Testing Data Summary
Testing of the Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System was performed in compliance with Nihon Kohden Corporation design control process. Testing included:
Software and hardware verification and validation, and the device is in compliance with the following voluntary industrial standards:
| IEC 60601-1 | Part1: General requirements for safety 1998-12 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1, | Part 1: General Requirements for safety, Amendment 1, |
| Amendment 1 | 1991-11 |
| IEC 60601-1, | Part 1: General Requirements for safety, Amendment 2, |
| Amendment 2 | 1995-03 |
| IEC 60601-1-1<br>2nd edition | Part 1-1: General requirements for safety - Collateral<br>standard. Safety requirements for medical electrical<br>systems, 2000-12 |
| IEC 60601-1-2 | Part 1-2: General requirements for safety - Collateral |
| 2nd edition | standard. Electromagnetic compatibility, 2001-09 |
| IEC 60601-1-2 | Part 1-2: General requirements for safety - Collateral |
| 2nd edition, | standard. Electromagnetic compatibility. |
| Amendment 1 | Amendment 1, 2004 |
| IEC 60601-2-40 | Part 2-40: Particular Requirements for the safety of<br>electromyographs and evoked response equipment, 1998-<br>02 |
| CAN/CSA-C22.2 | Medical electrical equipment, Part 1: General requirements |
| No. 601.1-M90 | for safety. |
| CAN/CSA-C22.2<br>No. 601.1S1-94 | Supplement No. 1-94 to CAN/CSA-C22.2 No. 601-1-M90<br>Medical Equipment- Part 1:General requirements for<br>safety. |
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| CAN/CSA-C22.2<br>No. 601.1B-90 | Amendment 2 to CAN/CSA-C22.2 No. 601.1-M90<br>Medical equipment Part 1: General requirements for<br>safety: 2002 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CAN/CSA-C22.2<br>No. 60601-1-1-02 | Medical electrical equipment. Part 1-1: General<br>requirements for safety- Collateral: Safety requirements for<br>medical electrical systems, 2006 |
| CAN/CSA-C22.2<br>No.60601-1-2-03 | Medical Electrical Equipment . Part 1-2: General<br>Requirements for Safety . Collateral Standard:<br>Electromagnetic Compatibility . Requirements and Tests<br>(Adopted IEC 60601-1-2:2001, second edition, 2001-09) |
| CAN/CSA-C22.2<br>No. 60601-2-40-01 | Medical electrical equipment, Part 2-40: Particular<br>requirements for safety of electromyographs and evoked<br>response equipment (adopted 60601-2-40: 1998) |
#### Clinical Testing Data Summary .
No clinical testing performed for this submission.
## Substantial equivalence comparison 5.0
## 5.1 Intended Use
| MEB-2300A NEW DEVICE | | MEB-2200A PREDICATE (K991899) | |
|----------------------|----------------------------------------------------------------------------------------------|-------------------------------|------|
| 1. | Monitor, record and display bioelectric signals produced by muscles and nerves (EMG). | 1. | Same |
| 2. | Measure, record and display nerve conduction time (NCV). | 2. | Same |
| 3. | Determine autonomic responses by measuring electrical resistance of the skin and tissue path | 3. | Same |
| 4. | Measure evoked response using electrical, visual or auditory stimulus (EP). | 4. | Same |
| 5. | Measure, record and display the electrical activity of the patient's brain (EEG). | 5. | Same |
#### 5.2 Physical Characteristics
:
| MEB-2300A NEW DEVICE | MEB-2200A PREDICATE (K991899) |
|----------------------|-------------------------------|
.
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| 1. | Bio-potential signals are amplified, filtered and digitized in the input junction box and sent to the main unit. | 1. | Same |
|----|------------------------------------------------------------------------------------------------------------------|----|------|
| 2. | The main unit controls stimulation triggers. | 2. | Same |
| 3. | Waveforms are displayed on monitor and/or printed. | 3. | Same |
| 4. | Waveforms may be permanently stored to storage media for future retrieval. | 4. | Same |
## Target Population and Environment 5.3
.
| MEB-2300A NEW DEVICE | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Adults and children. |
| 2. | 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 may also be placed in the intensive care unit or operating room for continuous recording. |
| MEB-2200A PREDICATE (K991899) | |
|-------------------------------|------|
| 1. | Same |
| 2. | Same |
#### Specifications 5.4
| | MEB-2300A New Device | MEB-2200A Predicate Device<br>(K991899) |
|---------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| AMPLIFIERS: | | |
| Number of Channels | 6, 12 channels | 4, 8, 16 channels |
| Active Electrode jack | 4 ports | None |
| Input Impedance | 200 $MΩ$ ±20% (Differential Mode)<br>1000 $MΩ$ or greater (Common<br>Mode) | Same |
| Noise | 0.6 $\mu$ Vrms | Same |
| Common Mode Rejection<br>Ratio (CMRR) | 106 dB or greater<br>(Differential mode)<br>112 dB or greater (Isolation mode) | Same |
| Sensitivity | 1 to 500 µV/div and 1 to 10 mV/div | Same |
| Low-cut Filter | 0.01 Hz to 3 KHz at 6 dB/octave | Same |
| High-cut Filter | 10 Hz to 20 KHz at 12 dB/octave | Same |
| Electrode Impedance<br>Check | 2, 5, 10, 20, 50kΩ indication | Same |
| Amplitude Calibration | 1, 10, 100 μV, 1, 10mV | Same |
| AC Filter | 50 or 60 Hz | Same |
| AVERAGERS: | | |
| A/D Converter | 18 bits | 16 bits |
| Conversion Speed | 5 µs/channel max. | 10 µs/channel max. |
| Monitor Time Base | 5 ms/div to 1 s/div | Same |
| Analysis Time Base | 0.1 ms/div to 1 s/div | Same |
| Time Base Modes | Individually selected for each<br>channel | Same |
| Delay Time | -10 to +10 div in 1 div steps | Same |
| Trigger Modes | Recurrent, Random, Foot Switch,<br>Signal,EXT1/2/3/4/5/6, Somato1,<br>Somato3 | Recurrent, Random, Foot<br>Switch, Signal, EXT1/2/3/4<br>Somato1,<br>Somato3, Trig1/2/3/4End |
| Number of Averages | 1 to 9999 | Same |
| Artifact Reject Inhibit<br>Range | ±1 to ±5 div or OFF | Same |
| DISPLAY: | | |
| Display | Color | Same |
| Number of Waveform<br>Traces | 312 Maximum | 416 Maximum |
| Waveform Display Modes | Monitor, Sweep, Analysis | Same |
| Cursors | 2 horizontal, 2 vertical | Same |
| Scale | 5, 10, 15, 20 div | Same |
| Grid (graticule) Display | Line, Dot, OFF | Same |
| STIMULATOR COMMON<br>FUNCTIONS: | | |
| Stimulus Modes | Single, Double, Train, Train series<br>(Multi train, Number of train: 1 to<br>10) | Single, Double, Train |
| Stimulus Rates | 0.1 Hz to 100 Hz | Same |
| Delay Time | 0 to 10 seconds | Same |
| ELECTRIC<br>STIMULATORS: | | |
| Number of Outputs | 4 | Same |
| Stimulus Intensity | 0 to 200 mA | 0 to 100 mA |
| Stimulus Pulse Duration | 0.01 to 1 ms | Same |
| AUDITORY<br>STIMULATORS: | | |
| Output Type | Headphone | Same |
| Stimulus Modes | Click, Tone Burst | Same |
| Stimulus Phase | Condensation, Rarefaction,<br>Alternating | Same |
| Stimulus Intensity | 0 to 135 dB SPL | Same |
| Contralateral White Noise<br>Masking | 0 to -40 dB, or OFF | Same |
| Click Pulse Duration | 0.1 to 1 ms | Same |
| Tone Burst Frequency | 50 Hz to 10 KHz | Same |
| Plateau Time | 0 to 1000 ms | Same |
| Rise/Fall Time | 0.1 to 10 ms | Same |
| VISUAL STIMULATORS: | | |
| Stimulus Modes | Pattern Reversal, Flash (with LED<br>goggles), External Visual<br>Stimulation | Same |
| Patterns | Checkerboard, Horizontal Bars,<br>Vertical Bars | Same |
| Number of Horizontal<br>Divisions | 4, 8, 16, 32, 64, 128 | Same |
| RECORDER: | | |
| Recording Mode | Hard Copy, Review, Report | Same |
| DIMENSIONS / WEIGHT: | | |
| Main Unit | 390 (W) x 55 (H) x 304 (D) mm<br><br>3.2 kg | 670 (W) x 1320 (H) x 800 (D) mm<br><br>14.3 kg |
| Electrode Junction Box | 180 (W) x 56.5 (H) x 234.5 (D) mm<br><br>1.5 kg | 4/8channels :210 (W) x 180 (H) x 75 (D) mm 1.8kg<br><br>16 channels: 257(W) x 182(H) x 68D) mm 2.4kg |
| Power Unit | The Main Unit includes Power Unit. | Same |
| POWER<br>REQUIREMENTS: | | |
| Line Voltage | 100-120 V AC,220-240V AC | 117 V AC |
| Line Frequency | 50/60 Hz | Same |
| Power Input | Less than 75 VA | Less than 450 VA |
| ENVIRONMENT: | | |
| Operating Temperature | 10 to 35 °C | Same |
| Storage Temperature | -20 to +65 °C | -20 to +60 °C |
| Operating Humidity | 30 to 80% | 20 to 80% |
| Storage Humidity | 10 to 95% | 20 to 80% |
| Operating Atmospheric<br>Pressure | 700 to 1060 hPa | Same |
| Storage Atmospheric<br>Pressure | 700 to 1060 hPa | Same |
| TEST PROTOCOLS<br>AVAILABLE: | | |
| | | |
| Somatosensory evoked<br>potential | SEP (somatosensory evoked<br>potential) | Same |
| | SSEP (short-latency<br>smoatosensory evoked potential) | |
| | ECG-SSEP (ECG triggered SSEP) | |
| | ESCP (evoked spinal cord<br>potential) | |
| | ELECTRIC (customizable protocol) | |
| Auditory evoked<br>potential | ABR (auditory brainstem response) | Same |
| | MLR (middle latency response) | |
| | SVR (slow vertex response) | |
| | ECOCHG (eletrocochlegram) | |
| | AUDITORY (customizable protocol) | |
| Visual evoked potential | PR-VEP (pattern reversal visual<br>evoked potential | Same |
| | LED-VEP (LED visual evoked<br>potential) | |
| | EXT-VEP (External stimulator visual<br>evoked potential) | |
| | ERG (Electroretinogram) | |
| | EOG (Electroculogram) | |
| | VISUAL (customizable protocol) | |
| EMG (electromyogram) | EMG (electromyogram) | EMG (electromyogram) |
| | EMG 2(electromyogram2) | QEMG (Quantitative EMG) |
| | QEMG (Quantitative EMG) | SF EMG (single fiber EMG) |
| | SF EMG (single fiber EMG) | MACRO (macro EMG) |
| Nerve Conduction | | |
| | MCS (motor nerve conduction) | MCS (motor nerve conduction) |
| | SCS (sensory nerve conduction) | SCS (sensory nerve conduction) |
| | NCS (nerve conduction studies) | REP.STIM (repetitive<br>stimulation) |
| | REP.STIM (repetitive stimulation) | F-WAVE |
| | F-WAVE | H-REFLEX (monosynaptic reflex<br>H-wave) |
| | H-REFLEX (monosynaptic reflex H-<br>wave) | BLINK (blink reflex) |
| | BLINK (blink reflex) | COLLISION (collision method) |
| | COLLISION (collision method) | |
| Autonomic Nervous<br>System | MICRO-N (microneurography of<br>sympathetic nerve activity) | Same |
| | SSR (Sympathetic skin response)<br>R-R Interval | |
| Event related potentials | P-300 (Long latency potential) | Same |
| | MRCP (Movement-related cortical<br>potential) | |
| | CNV (Contingent negative variation) | |
| Trend Monitoring | IOM | Same |
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## Differences 5.5
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| | MEB-2300A<br>New Device | MEB-2200A<br>Predicate Device | Rationale for Change |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of<br>Channels | 6, 12 channels | 4,8,16 channels | Number of channels of<br>each electrode junction box<br>increases as follows,<br>- 4 to 6<br>- 8 to 12<br>- 16 to (32 pending, it is<br>not. available yet.) |
| Active<br>Electrode<br>jack | 4 ports | None | Noise is highly reduced by<br>active electrode system. |
| A/D<br>Converter | 18 bits | 16 bits | Higher resolution |
| Conversion<br>Speed | 5 µs/channel max. | 10 µs/channel max. | Higher sampling speed |
| Number of<br>Waveform<br>Traces | 312 Maximum<br>(26/channel x 12) | 416 Maximum<br>(26/channel x 16) | Number of waveform traces<br>per channel remains the<br>same. |
| Stimulus<br>Modes | Single, Double, Train,<br>Train series (Multi train,<br>Number of train: 2 to 10) | Single, Double, Train | Train series is added. |
| Trigger<br>Modes | Recurrent, Random,<br>Foot Switch,<br>Signal,EXT1/2/3/4/5/6,<br>Somato1, Somato3 | Recurrent, Random,<br>Foot Switch, Signal,<br>EXT1/2/3/4 Somato1,<br>Somato3,<br>Trig1/2/3/4End | External trigger input<br>increases and connectable<br>external device also<br>increases. As a result,<br>complex waveform can be<br>acquired. Train series was<br>required but not available in<br>current device. Therefore,<br>"trig 1/2/3/4End" was used<br>as substitute for train<br>series. |
| Stimulus<br>Intensity | 0 to 200 mA | 0 to 100 mA | More stimulus intensity<br>NIM-Spine by Medtronic<br>(K#031510) also output the<br>intensity up to 200mA. |
| | MEB-2300A<br>New Device | MEB-2200A<br>Predicate Device | Rationale for Change |
| EMG<br>(electromyog<br>ram) | EMG (electromyogram)<br>EMG<br>2(electromyogram2)<br>QEMG (Quantitative<br>EMG)<br>SF EMG (single fiber<br>EMG)<br>MACRO (macro EMG) | EMG (electromyogram)<br>QEMG<br>SF EMG (single fiber<br>EMG)<br>MACRO (macro EMG) | EMG2: Measuring mode<br>with up to 4 measurement<br>settings available<br>EMG: Only one<br>measurement setting |
| Nerve<br>Conduction | MCS (motor nerve<br>conduction)<br>SCS (sensory nerve<br>conduction)<br>NCS (nerve<br>conduction studies)<br>REP.STIM (repetitive<br>stimulation)<br>F-WAVE<br>H-REFLEX<br>(monosynaptic reflex<br>H-wave)<br>BLINK (blink reflex)<br>COLLISION (collision<br>method) | MCS (motor nerve<br>conduction)<br>SCS (sensory nerve<br>conduction)<br>REP.STIM (repetitive<br>stimulation)<br>F-WAVE<br>H-REFLEX<br>(monosynaptic reflex<br>H-wave)<br>BLINK (blink reflex)<br>COLLISION (collision<br>method) | MCS, SCS, and T-WAVE<br>are integrated in one<br>program as NCS for<br>efficient routine<br>examination. |
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#### 6.0 Conclusions
・
The safety and effectiveness of the Nihon Kohden MEB-2300 was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Nihon Kohden MEB-2300A is equivalent to the predicate devices MEB-200A. No new questions of safety or effectiveness are raised.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
# Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nihon Kohden America, Inc. c/o Mr. Steve Geerdes Director of Regulatory Affairs and Ouality Assurance 90 Icon Street Foothill Ranch, CA 92610
SEP 19 2012
Re: K120397
Trade/Device Name: MEB-2300A Neuropack Evoked Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, GWE, GWJ, GWQ, GZO, IKN Dated: September 4, 2012 Received: September 5, 2012
Dear Mr. Steve Geerdes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
n
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D.. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K120397
# Device Name: MEB-2300A Neuropack Evoked Potential and EMG Measuring System
Indications For Use:
The Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the maooloo, to earning produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nene conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device 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 and the tlood pain boom betwity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
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 or naroing nome oot... The device may also be placed in the intensive care unit or operating room for continuous recording.
The device is available for use on any patient as determined by the medical professional including adults and children.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
John Grimes, Ph.D.
(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K120397
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