(103 days)
Not Found
No
The summary explicitly states that the Nemus 2 System is not involved in the data management performed by the host computer, which is where any potential AI/ML processing would occur. The device's function is described as signal acquisition, amplification, filtering, and analog-to-digital conversion.
No
The device is intended to acquire bioelectric signals and stimulate the nervous system for diagnostic purposes, not to treat a condition.
Yes
The device acquires bioelectric signals for recording neurophysiology examinations, which are used to assess the function of the nervous system and muscles. While it doesn't directly provide a diagnosis, it gathers critical data that clinicians use to diagnose conditions related to the central and peripheral nervous systems and muscles. The stated "Intended Use / Indications for Use" specifies its role in acquiring signals for "neurophysiology examinations," which are inherently diagnostic in nature, providing data points for clinicians to interpret and diagnose.
No
The device description explicitly lists hardware components such as an amplifier/stimulator, AC/DC converter, junction box, and optional keyboard and Flash LED stimulator. While it interacts with software on a host PC, it is not solely software.
Based on the provided information, the Nemus 2 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Nemus 2 Intended Use: The Nemus 2 System is intended to acquire bioelectric signals directly from the patient's central and peripheral nervous system and muscles. It uses external stimuli (electrical, sound, visual) and amplifies and processes these signals.
- No Specimen Analysis: The description clearly states that the device acquires signals from the patient and transmits them to a PC for further processing. There is no mention of analyzing biological specimens.
Therefore, the Nemus 2 System falls under the category of a physiological signal acquisition and stimulation device used for neurophysiology examinations, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
GWL, GWF, GWE, GWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's central and peripheral nervous system and muscles
Indicated Patient Age Range
Pediatric through adult
Intended User / Care Setting
Hospitals, laboratory, institutions, or other test environments
The device may be placed in Intensive Care Unit or Operating Room for continuous recording.
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
The devices have been evaluated for electrical, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.
- IEC 60601-1
- IEC 60601-1-1
- IEC 60601-1-2
- IEC 60601-1-4
- IEC 60601-2-26
- IEC 60601-2-40
Verification testing was conducted to demonstrate that the Nemus 2 met technical specifications including saturation, polarization, offset & gain, noise, CMRR, IMRR, and input impedance. The testing successfully verified that the Nemus 2 meets the technical specifications.
No clinical tests were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
0
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. | |
| Via Pietro Fanfani 97/a | |
| Florence, Italy 50127 | |
| Contact Person: | Allison Scott |
| 317.228.8719 | |
| Allison.Scott@Navigant.com | |
| 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 |
| 21 CFR 882.1870 Evoked response electrical stimulator, Product Code | |
| GWF | |
| 21 CFR 882.1890 Evoked response photic stimulator, Product Code GWE | |
| 21 CFR 882.1900 Evoked response auditory stimulator, Product Code | |
| 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
Characteristic | Nemus2 OEM System
(submission device) | Nemus1 System
(Predicate Device) | BE Plus LTM
(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
Amplifier, Electrical
stimulator, Audio, photic
stimulator | Electromyograph | Physiological signal
Amplifier, |
| Regulation Number | 882.1835 | 890.1375 | 882.1835 |
| Product | Nemus2 Amplifier
(submission device) | Nemus1 System
(Predicate Device) | BE Plus LTM
(Predicate Device) |
| Characteristic | | | |
| Labeling | | | |
| 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. | The Nemus1 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 may use
electrical stimulus or
sound stimulus for use in
evoked response
measurements (EP). | Acquisition of EEG,
polygraphy and
polysomnography
signals and
transmission of these to
a PC during recording
of neurophysiology
examinations |
| Warnings | Items related to off-
label use | same | same |
| Contraindication | 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 | same | same |
| Target population | Pediatric through adult | same | same |
| Environment of use | Hospitals, laboratory,
institutions, or other test
environments
The device may be placed
in Intensive Care Unit or | Hospitals, institutions,
or other test
environments. | Hospitals,
institutions, or other
test environments |
| Product Characteristic | Nemus2 Amplifier
(submission device) | Nemus1 System
(Predicate Device) | BE Plus LTM
(Predicate Device) |
| Prescription status | Operating Room for continuous recording.
Available only on the order of a physician | same | same |
| User Service | No user service allowed | same | same |
| Design - General | | | |
| The device acquire
bioelectric signals
produced by
muscles and nerves
(EMG) | YES | YES | NO |
| Device acquire the
electrical activity of
the brain (EEG/EP) | YES | NO | YES |
| Patient inputs | 2 EMG channels
20 EEG/EP channels | 2 EMG channels | 64 EEG channels |
| Signal acquisition | Analog-to-digital
conversion at variable
sampling rate | same | same |
| Safety Standards | IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-2-26
IEC 60601-2-40 | IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-2-40 | IEC 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-1-6
IEC 60601-2-26 |
| Patient circuitry
isolation | Optic
EMG channels inputs,
electrical stimulator
outputs: BF Type
Acoustic stimulator
headphones: BF Type
External serial ports and
I/O: B Type
EP\EEG channels inputs:
CF Type | Optic
EMG channels inputs,
electrical stimulator
outputs: BF Type
Acoustic stimulator
headphones: BF Type
External serial ports and
I/O: B Type | Optic
Patient isolation BF
type
Auxiliary I/O
components ports:
B type |
| Product
Characteristic | Nemus2 Amplifier
(submission device) | Nemus1 System
(Predicate Device) | BE Plus LTM
(Predicate Device) |
| System Components | Nemus 2 Base Unit
(Amplifier)
AC/DC Adapter
Dedicated Keyboard
(optional)
LED Flash Stimulator
(optional) | Nemus 1 Base Unit
(Amplifier)
AC/DC Adapter
Dedicated Keyboard
(optional) | Amplifier Unit
AC/DC Adapter
Removable 64/32 ch.
Patient Box
Rechargeable battery
pack
Battery pack charger
Mixed power/Ethernet
link cabling
Expansion cable
LED Flash Stimulator
(optional) |
| Amplifier-Computer
interface | LAN Ethernet IEEE 802.3 | same | "wired LAN "
ETHERNET/IEEE
802.3
or
"wireless LAN "
WLAN/IEEE 802.11 |
| Amplifier Power
Supply | External IEC 60601-1
mains adapter | same | External IEC 60601-1
mains adapter
or
Internal battery pack |
| Size (H/W/D) mm | Nemus 2 Amplifier
170 (L) x 125 (W) x 35
(H) (mm) | Nemus 1 Amplifier
170 (L) x 125 (W) x 35
(H) (mm) | 188 (L) x 148 (W) x 40
(H) (mm) |
| Weight | Nemus 2 Amplifier
0.6 Kg | Nemus 1 Amplifier
0.45 Kg | 0.5 Kg |
| Case material | Nemus 2 Amplifier
Policarbonate
Macrolon 6557 UL VO | Nemus 1 Amplifier
Policarbonate
Macrolon 6557 UL VO | ABS Resin -
(AF312B). |
| Product | Nemus2 System | Nemus1 System | BE Plus LTM |
| Characteristic | (submission device) | (Predicate Device) | (Predicate Device) |
| Design - Acquisition | | | |
| Number of channels | 2 EMG
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
Nemus 1 | EMG Channels :
100 MΩ | EEG Channels: |
| | EEG/EP channels:
same as BE Plus LTM | | Comm. Mode : 3.3 MΩ
Differential : 6.6 MΩ |
| Noise | EMG Channels : Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
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)