NEMUS 2 SYSTEM

K133517 · Eb Neuro S.P.A. · GWL · Feb 26, 2014 · Neurology

Device Facts

• Record ID: K133517
• Device Name: NEMUS 2 SYSTEM
• Applicant: Eb Neuro S.P.A.
• Product Code: GWL · Neurology
• Decision Date: Feb 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1835
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nemus 2 System is intended to acquire the bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The Nemus 2 System consists of a physiological signal amplifier, an evoked response auditory stimulator, an evoked response electrical stimulator, and an evoked response photic stimulator. The user needs to assure compatibility of the Nemus 2 System to the other components of the user's own system.

Device Story

Nemus 2 is a physiological signal amplifier/stimulator system for neurophysiology examinations. It captures bioelectric signals from the central/peripheral nervous system and muscles via electrodes/sensors. The device amplifies, filters, and performs analog-to-digital conversion of these signals before transmitting them to a host PC for analysis. It includes integrated electrical, auditory, and photic stimulators for evoked response analysis. Used in hospitals, laboratories, and institutions by clinicians. The system consists of a base unit (amplifier), AC/DC converter, junction box, and optional peripherals (keyboard, LED flash stimulator). The host PC runs application software to process and display data; the device itself does not perform data management. The output allows clinicians to record and analyze neurophysiological activity to aid in diagnosis and prognosis. Benefits include enhanced diagnostic capability through combined EMG and EEG/EP channel acquisition.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing, including electrical, electromagnetic, and mechanical safety evaluations (IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-26, 60601-2-40) and verification of technical specifications such as saturation, polarization, offset, gain, noise, CMRR, IMRR, and input impedance.

Technological Characteristics

Physiological signal amplifier with 2 EMG and 20 EEG/EP channels. Materials: Polycarbonate (Macrolon 6557 UL VO). Connectivity: LAN Ethernet IEEE 802.3. Power: External IEC 60601-1 mains adapter. Isolation: BF Type (EMG/Acoustic), CF Type (EEG/EP). Sampling: 16384 Hz (EEG/EP), 32768 Hz (EMG). A/D conversion: 24-bit (EMG), 16-bit (EEG/EP). Includes constant current electrical stimulator, audio stimulator, and optional LED flash stimulator.

Indications for Use

Indicated for pediatric through adult patients requiring acquisition of bioelectric signals from the central and peripheral nervous system and muscles for neurophysiology examinations. Contraindicated for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

• Nemus 1 (K073415)
• BE Plus LTM (K121996)

Submission Summary (Full Text)

{0}------------------------------------------------

K133517

FEB 26 2014

# Traditional 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.

807.92(a)(1)

| Submitter Information | |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EB Neuro, S.p.A.<br>Via Pietro Fanfani 97/a<br>Florence, Italy 50127 | |
| Contact Person: | Allison Scott<br>317.228.8719<br>[e-mail] |
| Date: | January 17, 2014 |
| 807.92(a)(2) | |
| | Devices |
| Common Name: | Physiological Signal Amplifier |
| Trade Name: | Nemus 2 |
| Classification Name(s): | Physiological Signal Amplifier |
| Classification Number: | 21 CFR 882.1835 Physiological signal amplifier, Product Code GWL<br>21 CFR 882.1870 Evoked response electrical stimulator, Product Code<br>GWF<br>21 CFR 882.1890 Evoked response photic stimulator, Product Code GWE<br>21 CFR 882.1900 Evoked response auditory stimulator, Product Code<br>GWJ |
| Regulatory Class: | Class II |
| 807.92(a)(2) | |

| Predicate Device(s) | | |
|---------------------|----------|---------|
| Device | Owner | 510(k) |
| Nemus 1 | EB Neuro | K073415 |
| BE Plus LTM | EB Neuro | K121996 |

{1}------------------------------------------------

807.92(a)(4)

### Device Description

The Nemus 2 System is made up of the Nemus 2 Amplifier/Stimulator, an AC/DC converter to power the amplifier, a "junction box" to connect the system to the Host PC, and (optionally) by a dedicate keyboard and a Flash LED stimulator.

The Nemus 2 System is intended to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The device may use electrical stimulus, sound stimulus, or visual stimulus for use in evoked response analysis.

The Nemus 2 System is an amplifier/stimulator device especially developed to amplify biological signals. The amplifier captures the biological signal from the human body through specialized sensors or electrodes, amplifies the very low electrical signal, and filters it to accomplish an antialiasing in order to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are "passed" to a host computer, which at this point is free to elaborate the data following the logic of the application software running on the host. The Nemus 2 System is not involved in the data management performed by the host.

807.92(a)(5)

### Intended Use

The Nemus 2 System is intended to acquire the bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The Nemus 2 System consists of a physiological signal amplifier, an evoked response auditory stimulator, an evoked response electrical stimulator, and an evoked response photic stimulator. The user needs to assure compatibility of the Nemus 2 System to the other components of the user's own system.

{2}------------------------------------------------

807.92(a)(6)

### Technological Characteristics

The Nemus 2 is very similar to the Nemus 1 both from the hardware and the software point of view. Nemus 2 may be considered an "enhanced" version of Nemus 1. Practically the Nemus 1 with an added internal board deputed to the Acquisition of the 20 EEG/EP channels. The case is practically identical with the obvious exception of the upper panel in which, in the Nemus 2 have been allocated the input sockets for the added channels.

In particular in relation to the internal stimulators:

- -The audio stimulator is absolutely identical
- । The electric stimulator of the Nemus 2 is the same of the Nemus 1, but with the difference that in the Nemus 2 the electric pulse may be delivered to 5 different output sockets. Under control of the firmware the stimulus may be delivered on one of this 5 output, but only one may be active at the same time, so also the Nemus 2 simulator has "only" one output. Apart from this aspect the two stimulators are identical.

The two devices use the same AC/DC mains adapter.

Parts of the system external the "Base unit" (the amplifier), i.e. the connection box, the link cable, the stimulation probe, the optional dedicated myographic keyboard, are the same for both devices.

The firmware is substantially the same with the only obvious exception of the added 20 EEG/EP channels. Apart from this, the host communication protocol is the same for both devices.

Differently from the Nemus 2 can handle, as an option, the EBNeuro Flash LED stimulator, useful during EEG or Visual Evoked Potential exams.

The Nemus 2 20 EEG/EP channels use the same technology of the 64 channels of the BE Plus LTM.

The part of Nemus 2 host communication protocol related to the transmission of the EEG data is substantially the same to the BE Plus LTM due to the fact that the processing architecture is very similar.

The Nemus 2 and BE Plus LTM devices can handle the same (optional) EBNeuro Flash LED stimulator.

The Nemus 2 and BE Plus LTM devices use the same AC/DC mains adapter. However the BE Plus LTM may be powered also from internal batteries.

An obvious difference is that the BE Plus LTM is not capable to hannels due to absence of internal stimulator and due to the technical characteristic of its acquisition channels (band, sampling rate, etc)

{3}------------------------------------------------

## Substantial Equivalence Comparison Table

| Product<br>Characteristic | Nemus2 OEM System<br>(submission device) | Nemus1 System<br>(Predicate Device) | BE Plus LTM<br>(Predicate Device) |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Manufacturer | EBNeuro S.p.A. | EBNeuro S.p.A. | EBNeuro S.p.A. |
| 510(k) number | TBA | K073415 | K121996 |
| Device class | Class II | Class II | Class II |
| Product code | GWL, GWF,GWJ, GWE | IKN, GWF,GWJ,JXE | GWL |
| Device type | Physiological signal<br>Amplifier, Electrical<br>stimulator, Audio, photic<br>stimulator | Electromyograph | Physiological signal<br>Amplifier, |
| Regulation Number | 882.1835 | 890.1375 | 882.1835 |
| Product | Nemus2 Amplifier<br>(submission device) | Nemus1 System<br>(Predicate Device) | BE Plus LTM<br>(Predicate Device) |
| Characteristic | | | |
| Labeling | | | |
| Intended use | The Nemus 2 System is<br>intended to acquire the<br>bioelectric signals<br>produced by the patient's<br>central and peripheral<br>nervous system and<br>muscles. The acquired<br>signals are transmitted to a<br>PC during recording of<br>neurophysiology<br>examinations.<br>The Nemus 2 System<br>consists of a physiological<br>signal amplifier, an<br>evoked response auditory<br>stimulator, an evoked<br>response electrical<br>stimulator, and an evoked<br>response photic stimulator.<br>The user needs to assure<br>compatibility of the<br>Nemus 2 System to the<br>other components of the<br>user's own system. | The Nemus1 system is<br>intended to monitor,<br>record and display the<br>bioelectric signals<br>produced by muscles, to<br>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 disease<br>(EMG).<br>The device may use<br>electrical stimulus or<br>sound stimulus for use in<br>evoked response<br>measurements (EP). | Acquisition of EEG,<br>polygraphy and<br>polysomnography<br>signals and<br>transmission of these to<br>a PC during recording<br>of neurophysiology<br>examinations |
| Warnings | Items related to off-<br>label use | same | same |
| 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 equipment | same | same |
| Target population | Pediatric through adult | same | same |
| Environment of use | Hospitals, laboratory,<br>institutions, or other test<br>environments<br>The device may be placed<br>in Intensive Care Unit or | Hospitals, institutions,<br>or other test<br>environments. | Hospitals,<br>institutions, or other<br>test environments |
| Product Characteristic | Nemus2 Amplifier<br>(submission device) | Nemus1 System<br>(Predicate Device) | BE Plus LTM<br>(Predicate Device) |
| Prescription status | Operating Room for continuous recording.<br>Available only on the order of a physician | same | same |
| User Service | No user service allowed | same | same |
| Design - General | | | |
| The device acquire<br>bioelectric signals<br>produced by<br>muscles and nerves<br>(EMG) | YES | YES | NO |
| Device acquire the<br>electrical activity of<br>the brain (EEG/EP) | YES | NO | YES |
| Patient inputs | 2 EMG channels<br>20 EEG/EP channels | 2 EMG channels | 64 EEG channels |
| Signal acquisition | Analog-to-digital<br>conversion at variable<br>sampling rate | same | same |
| Safety Standards | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-1-4<br>IEC 60601-2-26<br>IEC 60601-2-40 | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-1-4<br>IEC 60601-2-40 | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-1-4<br>IEC 60601-1-6<br>IEC 60601-2-26 |
| Patient circuitry<br>isolation | Optic<br>EMG channels inputs,<br>electrical stimulator<br>outputs: BF Type<br><br>Acoustic stimulator<br>headphones: BF Type<br><br>External serial ports and<br>I/O: B Type<br><br>EP\EEG channels inputs:<br>CF Type | Optic<br>EMG channels inputs,<br>electrical stimulator<br>outputs: BF Type<br><br>Acoustic stimulator<br>headphones: BF Type<br><br>External serial ports and<br>I/O: B Type | Optic<br>Patient isolation BF<br>type<br><br>Auxiliary I/O<br>components ports:<br>B type |
| Product<br>Characteristic | Nemus2 Amplifier<br>(submission device) | Nemus1 System<br>(Predicate Device) | BE Plus LTM<br>(Predicate Device) |
| System Components | Nemus 2 Base Unit<br>(Amplifier)<br>AC/DC Adapter<br>Dedicated Keyboard<br>(optional)<br>LED Flash Stimulator<br>(optional) | Nemus 1 Base Unit<br>(Amplifier)<br>AC/DC Adapter<br>Dedicated Keyboard<br>(optional) | Amplifier Unit<br>AC/DC Adapter<br>Removable 64/32 ch.<br>Patient Box<br>Rechargeable battery<br>pack<br>Battery pack charger<br>Mixed power/Ethernet<br>link cabling<br>Expansion cable<br>LED Flash Stimulator<br>(optional) |
| Amplifier-Computer<br>interface | LAN Ethernet IEEE 802.3 | same | "wired LAN "<br>ETHERNET/IEEE<br>802.3<br>or<br>"wireless LAN "<br>WLAN/IEEE 802.11 |
| Amplifier Power<br>Supply | External IEC 60601-1<br>mains adapter | same | External IEC 60601-1<br>mains adapter<br>or<br>Internal battery pack |
| Size (H/W/D) mm | Nemus 2 Amplifier<br>170 (L) x 125 (W) x 35<br>(H) (mm) | Nemus 1 Amplifier<br>170 (L) x 125 (W) x 35<br>(H) (mm) | 188 (L) x 148 (W) x 40<br>(H) (mm) |
| Weight | Nemus 2 Amplifier<br>0.6 Kg | Nemus 1 Amplifier<br>0.45 Kg | 0.5 Kg |
| Case material | Nemus 2 Amplifier<br>Policarbonate<br>Macrolon 6557 UL VO | Nemus 1 Amplifier<br>Policarbonate<br>Macrolon 6557 UL VO | ABS Resin -<br>(AF312B). |
| Product | Nemus2 System | Nemus1 System | BE Plus LTM |
| Characteristic | (submission device) | (Predicate Device) | (Predicate Device) |
| Design - Acquisition | | | |
| Number of channels | 2 EMG<br>20 EEG/EP | 2 EMG | 64 EEG |
| CMRR | >100 dB | >100 dB | >98 dB |
| IMRR | >100 dB | >100 dB | >98 dB |
| Input impedance | EMG Channels: same as<br>Nemus 1 | EMG Channels :<br>>100 MΩ | EEG Channels: |
| | EEG/EP channels:<br>same as BE Plus LTM | | Comm. Mode : 3.3 MΩ<br>Differential : 6.6 MΩ |
| Noise | EMG Channels : < 0.3<br>µVrms (0.1 – 100 Hz)<br>EEG/EP channels: <20<br>nV/√Hz (10-10KHz) | EMG Channels : < 0.3<br>µVrms (0.1 - 100 Hz) | EEG Channels:<br><0.3µVrms (@256 Hz<br>sampling rate ) |
| A/D conversion | 24 bit (2 EMG bipolar<br>channels )<br>16bit (20 EEG/EP<br>unipolar channels) | 24 bit (2 EMG bipolar<br>channel) | 16 bit (64 EEG unipolar<br>channels) |
| Sampling rate | 16384 Hz (EEG/EP ch)<br>32768 Hz (EMG ch)<br>Oversampling = Fs<br>x 128 | 32768 Hz (EMG ch)<br>Oversampling = Fs x<br>128 | 8192 Hz/Channel |
| Antialiasing Low pass<br>filter | EMG ch. : 20 KHz<br>EEG/EP ch, 2 KHz | EMG ch. : 20 KHz | 2KHz 3rd order filter |
| High-pass Filter | 1.6s (0.1 Hz) or<br>16ms(10Hz)(EMG<br>channels)<br>1.6/160 ms (0.1/1 Hz)<br>(EEG/EP channels | 1.6s (0.1 Hz) or<br>16ms(10Hz)(EMG<br>channels) | selectable 0.1/10 Hz<br>1st order filter |
| Trigger mode | Free, Auto, Internal,<br>External | same | na |
| Ohmmeter | 0-100 kOhm (auto full<br>scale) | same | same |
| Product<br>Characteristic | Nemus System<br>(submission device) | Nemus1 System<br>(Predicate Device) | BE Plus LTM<br>(Predicate Device) |
| Design - Stimulators | | |…