NEMUS SYSTEM; NEMUS PC PERIPHERAL
Device Facts
| Record ID | K073415 |
|---|---|
| Device Name | NEMUS SYSTEM; NEMUS PC PERIPHERAL |
| Applicant | Eb Neuro S.P.A. |
| Product Code | IKN · Physical Medicine |
| Decision Date | May 23, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
NEMUS systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles. The NEMUS system is intended to monitor, record and display the bioelectric signal produced by the 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 diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).
Device Story
NeMus system and NeMus PC Peripheral are diagnostic electromyographs used in hospitals and clinical environments by physicians. The device detects bioelectric signals from peripheral nerves and skeletal muscles via isolated preamplifiers. It provides electrical or sound stimuli for evoked response (EP) measurements. The system consists of an amplifier (NeMus 1), host PC, and management software (GALILEO NT/MYTOWIN). It performs analog-to-digital conversion of signals, which are then processed, recorded, and displayed on a digital monitor. The system supports various clinical protocols including nerve conduction studies, spontaneous activity, single fiber EMG, and motor unit analysis. Clinicians use the displayed data to aid in the diagnosis and prognosis of neuromuscular diseases. The system is available in a complete cart-based configuration or as a PC peripheral kit.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1, 60601-1-1, 60601-2-26, 60601-2-40, 60601-1-2) and performance comparison of acquisition parameters (CMRR, noise, impedance, filter ranges) against predicate devices.
Technological Characteristics
Class II electromyograph. Components: NeMus 1 amplifier, host PC, optional cart. Connectivity: LAN Ethernet 100 Mbit. Power: 110-240 VAC via isolation transformer. Patient circuitry: Optic isolation. A/D conversion: 24-bit Sigma-Delta. Sampling rate: 4.194 MHz. Input impedance: >1000 MOhm. CMRR: >100 dB. Noise: <0.3 µVrms. Stimulators: Constant current electrical (up to 100 mA) and audio (125-8000 Hz). Software: GALILEO NT/MYTOWIN running on Microsoft Windows. Sterilization: Not applicable (non-invasive).
Indications for Use
Indicated for pediatric through adult patients for the diagnosis and prognosis of neuromuscular diseases via EMG and evoked response measurements (EP). Contraindicated for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment.
Regulatory Classification
Identification
A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
Predicate Devices
Submission Summary (Full Text)
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K073 4/5
MAY 2 3 2008
# 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
#### Submitter Information
Allison Scott Official Correspondent The Anson Group 11460 N. Meridian St. Suite 150 Carmel, IN 46032
Phone: (317) 569-9500 x 106 Facsimile: (317) 569-9520
Contact Person: Allison Scott
Date: December 3, 2007
807.92(a)(2)
| Trade Names: | Nemus System |
|--------------|---------------------|
| | Nemus PC Peripheral |
Common Name: Electromyograph
Classification Name(s): Electromyograph
IKN Classification Number:
807.92(a)(3)
#### Predicate Device(s)
| Esaote Biomedica | PHASIS | K922488 |
|------------------------|------------|---------|
| Oxford Instruments PLC | Sinergy LT | K981405 |
Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.
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807.92 (a)(4)
### Device Description
There are two configurations of NeMus: NeMus System and NeMus PC Peripheral.
The "Nemus system" is a complete system provided with a cart (expressly designed for this device and equipped with isolation transformer, the base unit support mobile arm, places for computer, keyboard, footswitch, printer, and dedicated keyboard and so on. The complete system provided of all the part ordered by the customer is completely wired, assembled and tested in factory before to ship to the final user. Like the hardware parts, all the needed software is installed and configured in factory.
The "Nemus PC Peripheral" is a base kit (constituted by the NeMus 1 Amplifier the AC/DC adapter, cables and GALILEO NT management software) which, by adding a Personal Computer, becomes a digital electromiograph system. This configuration is developed and verified in order to allow a Distributor or the User to "build" an acquisition/processing EMG signal system by using the NeMus 1 acquisition module, the GALILEO NT/MYTOWIN management software and their own Personal Computer (and peripherals). However the PC must be compliant with EBNeuro specified minimum requirements. Of course the "system builder" must follow all the indications detailed in the related User Manual provided with the system. In this kind of system configuration, the "base kit" provided by EBNeuro is a sort of "peripheral" of a PC system. This configuration allows the Distributor or the User to use its own PC, cart or other "system" arrangement of its choice.
NeMus systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles.
The Nemus system is intended to monitor, record and display the bioelectric signal produced by the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis of neuromuscular diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).
#### 807.92(a)(5)
#### Intended Use(s)
NEMUS systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles.
The NEMUS system is intended to monitor, record and display the bioelectric signal produced by the 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 diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).
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## Technological Characteristics Substantial Equivalence Comparison Table
| Product<br>Characteristic | Nemus System<br>(submission device) | PHASIS<br>(predicate device) | Sinergy LT |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Manufacturer | EBNeuro S.p.A. | Esaote Biomedica | Oxford Instruments<br>plc |
| 510(k) number | Not assigned | K922488 | K981405 |
| Device class | Class II | Class II | Class II |
| Product code | IKN | IKN | GMF |
| Device type | Electromyograph | Electromyograph | Stimulator, Electrical,<br>Evoked response |
| Regulation Number | 890.1375 | 890.1375 | 882.1870 |
| Product<br>Characteristic | Nemus System<br>(submission device) | PHASIS<br>(predicate device) | Sinergy LT |
| Labeling | | | |
| Intended use | The NEMUS system is<br>intended to monitor,<br>record and display the<br>bioelectric signal<br>produced by the muscles,<br>to stimulate peripheral<br>nerves, and to monitor,<br>record and display the<br>electrical activity<br>produced by nerves to aid<br>the clinician in the<br>diagnosis and prognosis of<br>neuromuscular diseases<br>(EMG). The device may<br>use electrical stimulus or<br>sound stimulus for use in<br>evoked response<br>measurements (EP). | The PHASIS<br>electomyograph is<br>intended for medical<br>purposes, such as to<br>monitor and display the<br>bioelectric signals<br>produced by muscles, to<br>stimulate peripheral<br>nerves, and to monitor and<br>display the electrical<br>activity produced by<br>nerves for the diagnosis<br>and prognosis of<br>neuromuscular disease | 2 channel<br>electromyograph which<br>provides facilities for<br>EMG and Evoked<br>Potentials testing for a<br>range of clinical<br>application.<br>Synergy LT is designed<br>to enable reliable<br>recording display and<br>documentation of<br>electrophysiological<br>information from the<br>human nervous and<br>muscular system in a<br>clinical environment. |
| Warnings | Items related to off-<br>label use. | Items related to off-<br>label use. | Items related to off-<br>label use. |
| Contraindication | Items related to design<br>and indicated use<br>limitations, such as not<br>for use in the presence<br>of flammable<br>anesthetics or in<br>conjunction with<br>defibrillation<br>equipment. | Items related to design<br>and indicated use<br>limitations, such as not<br>for use in the presence<br>of flammable<br>anesthetics | Items related to<br>design and indicated<br>use limitations, such<br>as not for use in the<br>presence of<br>flammable<br>anesthetics. |
| Target population | Pediatric through adult | Pediatric through adult | Pediatric through<br>adult |
| Environment of use | Hospitals, institutions,<br>or other test<br>environments. | Hospitals, institutions,<br>or other test<br>environments | Hospitals,<br>institutions, or other<br>test environments |
| Prescription status | Available only on the<br>order of a physician. | Available only on the<br>order of a physician. | Available only on the<br>order of a physician. |
| User Service | No user service allowed | No user service allowed | No user service allowed |
| Product<br>Characteristic | Nemus System<br>(submission device) | PHASIS<br>(predicate device) | Sinergy LT |
| <b>Design - General</b> | | | |
| General system<br>approach | Computer based<br>equipment with dedicated<br>hardware<br>peripherals/components | Computer based<br>equipment with dedicated<br>hardware<br>peripherals/components | Computer based<br>equipment with<br>dedicated hardware<br>peripherals/components |
| User input device | Microsoft Windows<br>mouse/keyboard driven<br>graphic interface.<br>Dedicated external<br>keyboard (optional) | ASCII keyboard with<br>application specific<br>function key.<br>Re-definable "soft" keys<br>with on-screen indication | Microsoft Windows<br>mouse/keyboard driven<br>graphic interface. |
| User output device | Digital color display<br>Commercial printers | Digital color display<br>Commercial printers | Digital color display<br>Commercial printers |
| Patient inputs | 2 channels preamplifiers,<br>isolated | 2-4 channels<br>preamplifiers, isolated | 2 channels<br>preamplifiers, isolated |
| Signal acquisition | Analog-to-digital<br>conversion at variable<br>sampling rate | Analog-to-digital<br>conversion at variable<br>sampling rate | Analog-to-digital<br>conversion at variable<br>sampling rate |
| Trigger input<br>(synchronization to<br>external events) | YES | YES | YES |
| Trigger output<br>(synchronization for<br>external devices) | YES | YES | YES |
| Footswitch for<br>hands-free<br>operation | YES (optional) | YES | YES |
| Use of standard<br>software platform<br>(Operating System) | YES - Microsoft<br>Windows | YES - Motorola Versados | YES - Microsoft<br>Windows |
| Customization of<br>clinical protocols | Via storage / retrieval of<br>user-defined settings | Via storage / retrieval of<br>user-defined settings | Via storage / retrieval<br>of user-defined settings |
| Application<br>flexibility /<br>expandability | Via software update | Via software update | Via software update |
| Safety Standards | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-2-26 | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-2-40<br>IEC 60601-1-2 | | |
| Patient circuitry<br>isolation | optic | optic | optic |
| System<br>Components | Nemus 1 Base Unit<br>(Amplifier)<br>Host Computer (PC)<br>Printer (optional)<br>Cart (optional)<br>Dedicated Keyboard<br>(optional) | Headbox (Amplifier)<br>Computer<br>Cart<br>Printer (optional) | Headbox (Amplifier)<br>Computer (PC)<br>Cart<br>Printer (optional) |
| Amplifier-<br>Computer interface | LAN Ethernet 100 Mbit | proprietary | proprietary |
| System Power<br>Supply | From mains (110-240<br>VAC) trough isolation<br>transformer | From mains (110-240<br>VAC) | From mains (110-240<br>VAC) |
| Amplifier Power<br>Supply | 15 VDC from medical<br>approved AC/DC<br>converter | Internal power supply | Internal power supply |
| Size (H/W/D) mm | Nemus System :<br>1250/750/850 (complete<br>system, with cart, monitor,<br>arm ) | 238/457/413 | 500/209/321<br>( cart : 720/640/780 ) |
| Weight<br>(complete system -<br>kg) | Nemus System : 90<br>(complete system, with<br>cart, monitor, arm) | 80 (with cart) | 55 (with cart) |
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| Product<br>Characteristic | Nemus System<br>(submission device) | PHASIS<br>(predicate device) | Sinergy LT |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design - Acquisition | | | |
| Number of channels | 2 | 2/4 | 2 |
| CMRR | >100 dB | >100 dB | > 110 dB |
| Noise | <0.3 µVrms (0.1 - 00 Hz)<br>$ < 20 nV/Hz^{\frac{1}{2}} $<br>(10 Hz - 10 kHz ) | <0.9 µVrms<br>(0.1 Hz - 10 kHz) | <0.7 µVrms<br>(0.1 Hz-10 kHz) |
| Input impedance | > 1000 MOhm / 8 pF | > 100 MOhm / 15 pF | > 1000 MOhm / 30 pF |
| Low pass filter | 20 Hz - 16 kHz (15<br>step) | 10 Hz - 20 kHz (11<br>step) | 50 Hz - 16 kHz (10<br>step) |
| High pass filter | 0.01 - 500 Hz (11 step) | 0.01 - 500 Hz (13 step) | DC, 30 – 2000 Hz |
| Notch filter | 50/60 Hz selectable | 50/60 Hz selectable | 50/60 Hz selectable |
| A/D conversion | 24 bit Sigma-Delta | 16 bit | 16 bit |
| Sampling rate | 4.194 MHz | 0.5 µs max | 50 kHz |
| Analysis time | 5 ms - 10 s | 1 ms - 20 s | 5 ms - 10s |
| Time base | Single | Single, dual | single |
| Trigger mode | Free, Auto, Internal,<br>External | Recurrent, manual, self,<br>external | Auto, Internal, External |
| Signal delay<br>(pre/post) | 0-5 div | 0-5 div | 0-9 div |
| Ohmmeter | 0-100 kOhm (auto full<br>scale) | 0-100 kOhm (auto full<br>scale) | 0 - 32 kOhm |
| Product<br>Characteristic | Nemus System<br>(submission device) | PHASIS<br>(predicate device) | Sinergy LT |
| Design - Stimulators | | | |
| Somatosensory<br>(electrical) Stimulator | Type: constant current<br>N. output : 1<br>Max output : 100 mA<br>Pulse width: 0.05 -<br>1ms<br>Mode: single, train | Type: constant<br>current/voltage<br>N. output : 1<br>Max output:100 mA<br>Pulse width: 0.01 - 1 ms<br>Mode: single, recurrent,<br>paired, trains | Type: constant<br>current/voltage<br>N. output : 1<br>Max output: 100 mA<br>Pulse width: 0.05-1 ms<br>Mode: single, double,<br>train |
| Audio Stilmulator | Output mode: click,<br>tone<br>Sound pressure: 0-132<br>dB SPL<br>Phase: condens., raref.,<br>alternate<br>Signal frequency: 125-<br>8000 Hz<br>Plateau time: 1-200 ms<br>Rise/fall time: 1-100<br>ms<br>Mask level: -40 - +10<br>dB (relative)<br>Click width: 1-100 μs<br>Stimulus presen. Left,<br>right, binaural<br>Headset: TDH 39 | Output mode: click, pip,<br>tone<br>Sound pressure: 20-132<br>dB SPL<br>Phase: condens., raref.,<br>alternate<br>Signal frequency: 125-<br>8000 Hz<br>Plateau time: 0-200 ms<br>Rise/fall time: 0-200 ms<br>Mask level: 0-90 dB<br>Click width: 50-500 μs<br>Stimulus presen. Left,<br>right, binaural<br>Headset: TDH 50P | Output mode: click.<br>pip, tone<br>Sound pressure: 0-122<br>dB SPL<br>Phase: condens., raref.,<br>alternate<br>Signal frequency: 125-<br>8000 Hz<br>Plateau time: 1-999 ms<br>Rise/fall time: 1-255 ms<br>Mask level: -40 - +10<br>dB (relative)<br>Click width: 0.05-1ms<br>Stimulus presen. Left,<br>right, binaural<br>Headset: TDH 39 |
| Basic EMG application<br>modules :<br>Free run acquisition<br>Nerve conduction study<br>Self triggered acquisition<br>Spontaneous activity<br>Single fiber EMG<br>Motor Unit Analysis | YES<br>YES<br>YES<br>YES<br>YES<br>YES | YES<br>YES<br>YES<br>YES<br>YES<br>YES | YES<br>YES<br>YES<br>YES<br>YES<br>YES |
| F wave analysis<br>Basic EP application<br>modules<br>Somatosensory EP<br>Auditory EP | YES<br>YES<br>YES | YES<br>YES<br>YES | YES<br>YES<br>YES |
| Visual EP (flash) | NO…
