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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Nemus 2 System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K133517) is a 510(k) summary for a medical device. In these summaries, acceptance criteria are typically presented as technical specifications that the new device must meet to demonstrate substantial equivalence to predicate devices. The study proving these criteria are met is usually a series of non-clinical bench tests.

Acceptance Criteria (Technical Specification)	Reported Device Performance (Nemus 2)
Safety Standards Conformity	Conforms to: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-26, IEC 60601-2-40
Saturation	Verified to meet technical specifications
Polarization	Verified to meet technical specifications
Offset & Gain	Verified to meet technical specifications
Noise (EMG Channels)	< 0.3 µVrms (0.1 – 100 Hz)
Noise (EEG/EP Channels)	< 20 nV/√Hz (10-10KHz)
CMRR (Common Mode Rejection Ratio)	>100 dB
IMRR (Input Mode Rejection Ratio)	>100 dB
Input Impedance (EMG)	Same as Nemus 1 (>100 MΩ)
Input Impedance (EEG/EP)	Same as BE Plus LTM (Comm. Mode: 3.3 MΩ, Differential: 6.6 MΩ)
Number of Channels (EMG)	2 EMG
Number of Channels (EEG/EP)	20 EEG/EP
A/D Conversion (EMG)	24 bit
A/D Conversion (EEG/EP)	16 bit
Sampling Rate (EEG/EP)	16384 Hz
Sampling Rate (EMG)	32768 Hz
Antialiasing Low Pass Filter (EMG)	20 KHz
Antialiasing Low Pass Filter (EEG/EP)	2 KHz
High-pass Filter (EMG)	1.6s (0.1 Hz) or 16ms (10Hz)
High-pass Filter (EEG/EP)	1.6/160 ms (0.1/1 Hz)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of this 510(k) summary for engineering verification. The "test set" here refers to the device itself and its components undergoing bench testing, not a dataset of patient cases.
Data Provenance: Not applicable. The "study" described is verification testing against technical specifications, not a study involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. Ground truth as typically defined for medical AI (e.g., expert labels on images) is not relevant for this type of device and study. The "ground truth" for the verification testing is adherence to established engineering specifications and medical device safety standards.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing involves objective measurements against predefined technical specifications and safety standards, not a subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

MRMC Study: No. This device is a physiological signal amplifier and stimulator, not an AI-powered diagnostic tool that would typically undergo MRMC studies to evaluate reader performance.
Effect Size of Human Readers: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This is a hardware device for acquiring and stimulating bioelectric signals, not an algorithm. Its performance is evaluated based on its ability to accurately amplify, filter, and stimulate according to its specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Conformity to international electrical and medical device safety standards (e.g., IEC 60601 series).
Demonstration through verification testing that the device meets its own established technical specifications for parameters such as noise, CMRR, IMRR, input impedance, and channel characteristics.
Substantial equivalence to predicate devices (Nemus 1 and BE Plus LTM) based on technological characteristics and intended use.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This is not an AI/machine learning device. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. There is no training set or associated ground truth in this context.

Summary

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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.Via Pietro Fanfani 97/aFlorence, Italy 50127
Contact Person:	Allison Scott317.228.8719Allison.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 GWL21 CFR 882.1870 Evoked response electrical stimulator, Product CodeGWF21 CFR 882.1890 Evoked response photic stimulator, Product Code GWE21 CFR 882.1900 Evoked response auditory stimulator, Product CodeGWJ
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

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807.92(a)(4)

Device Description

807.92(a)(5)

Intended Use

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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)

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Substantial Equivalence Comparison Table

ProductCharacteristic	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 signalAmplifier, Electricalstimulator, Audio, photicstimulator	Electromyograph	Physiological signalAmplifier,
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 isintended to acquire thebioelectric signalsproduced by the patient'scentral and peripheralnervous system andmuscles. The acquiredsignals are transmitted to aPC during recording ofneurophysiologyexaminations.The Nemus 2 Systemconsists of a physiologicalsignal amplifier, anevoked response auditorystimulator, an evokedresponse electricalstimulator, and an evokedresponse photic stimulator.The user needs to assurecompatibility of theNemus 2 System to theother components of theuser's own system.	The Nemus1 system isintended to monitor,record and display thebioelectric signalsproduced by muscles, tostimulate peripheralnerves and to monitorrecord and display theelectrical activityproduced by nerves to aidthe clinician in thediagnosis and prognosis ofneuromuscular disease(EMG).The device may useelectrical stimulus orsound stimulus for use inevoked responsemeasurements (EP).	Acquisition of EEG,polygraphy andpolysomnographysignals andtransmission of these toa PC during recordingof neurophysiologyexaminations
Warnings	Items related to off-label use	same	same
Contraindication	Items related to designand indicated uselimitations, such as notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillation equipment	same	same
Target population	Pediatric through adult	same	same
Environment of use	Hospitals, laboratory,institutions, or other testenvironmentsThe device may be placedin Intensive Care Unit or	Hospitals, institutions,or other testenvironments.	Hospitals,institutions, or othertest 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 acquirebioelectric signalsproduced bymuscles and nerves(EMG)	YES	YES	NO
Device acquire theelectrical activity ofthe brain (EEG/EP)	YES	NO	YES
Patient inputs	2 EMG channels20 EEG/EP channels	2 EMG channels	64 EEG channels
Signal acquisition	Analog-to-digitalconversion at variablesampling rate	same	same
Safety Standards	IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-26IEC 60601-2-40	IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-40	IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-4IEC 60601-1-6IEC 60601-2-26
Patient circuitryisolation	OpticEMG channels inputs,electrical stimulatoroutputs: BF TypeAcoustic stimulatorheadphones: BF TypeExternal serial ports andI/O: B TypeEP\EEG channels inputs:CF Type	OpticEMG channels inputs,electrical stimulatoroutputs: BF TypeAcoustic stimulatorheadphones: BF TypeExternal serial ports andI/O: B Type	OpticPatient isolation BFtypeAuxiliary I/Ocomponents ports:B type
ProductCharacteristic	Nemus2 Amplifier(submission device)	Nemus1 System(Predicate Device)	BE Plus LTM(Predicate Device)
System Components	Nemus 2 Base Unit(Amplifier)AC/DC AdapterDedicated Keyboard(optional)LED Flash Stimulator(optional)	Nemus 1 Base Unit(Amplifier)AC/DC AdapterDedicated Keyboard(optional)	Amplifier UnitAC/DC AdapterRemovable 64/32 ch.Patient BoxRechargeable batterypackBattery pack chargerMixed power/Ethernetlink cablingExpansion cableLED Flash Stimulator(optional)
Amplifier-Computerinterface	LAN Ethernet IEEE 802.3	same	"wired LAN "ETHERNET/IEEE802.3or"wireless LAN "WLAN/IEEE 802.11
Amplifier PowerSupply	External IEC 60601-1mains adapter	same	External IEC 60601-1mains adapterorInternal battery pack
Size (H/W/D) mm	Nemus 2 Amplifier170 (L) x 125 (W) x 35(H) (mm)	Nemus 1 Amplifier170 (L) x 125 (W) x 35(H) (mm)	188 (L) x 148 (W) x 40(H) (mm)
Weight	Nemus 2 Amplifier0.6 Kg	Nemus 1 Amplifier0.45 Kg	0.5 Kg
Case material	Nemus 2 AmplifierPolicarbonateMacrolon 6557 UL VO	Nemus 1 AmplifierPolicarbonateMacrolon 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 EMG20 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 asNemus 1	EMG Channels :>100 MΩ	EEG Channels:
	EEG/EP channels:same as BE Plus LTM		Comm. Mode : 3.3 MΩDifferential : 6.6 MΩ
Noise	EMG Channels : < 0.3µVrms (0.1 – 100 Hz)EEG/EP channels: <20nV/√Hz (10-10KHz)	EMG Channels : < 0.3µVrms (0.1 - 100 Hz)	EEG Channels:<0.3µVrms (@256 Hzsampling rate )
A/D conversion	24 bit (2 EMG bipolarchannels )16bit (20 EEG/EPunipolar channels)	24 bit (2 EMG bipolarchannel)	16 bit (64 EEG unipolarchannels)
Sampling rate	16384 Hz (EEG/EP ch)32768 Hz (EMG ch)Oversampling = Fsx 128	32768 Hz (EMG ch)Oversampling = Fs x128	8192 Hz/Channel
Antialiasing Low passfilter	EMG ch. : 20 KHzEEG/EP ch, 2 KHz	EMG ch. : 20 KHz	2KHz 3rd order filter
High-pass Filter	1.6s (0.1 Hz) or16ms(10Hz)(EMGchannels)1.6/160 ms (0.1/1 Hz)(EEG/EP channels	1.6s (0.1 Hz) or16ms(10Hz)(EMGchannels)	selectable 0.1/10 Hz1st order filter
Trigger mode	Free, Auto, Internal,External	same	na
Ohmmeter	0-100 kOhm (auto fullscale)	same	same
ProductCharacteristic	Nemus System(submission device)	Nemus1 System(Predicate Device)	BE Plus LTM(Predicate Device)
Design - Stimulators
Electric Stimulator	Type: constant currentN. output : 1Max output : 100 mAPulse width: 0.05 - 1msMode: single, train	Type: constant currentN. output : 1Max output : 100 mAPulse width: 0.05 - 1msMode: single, train	None
Audio Stimulator	Output mode: click, toneSound pressure: 0-132dB SPLPhase: condens., raref.,alternateSignal frequency: 125-8000 HzPlateau time: 1-200 msRise/fall time: 1-100 msMask level: -40 - +10dB (relative)Click width: 1-100 $\mu$ sStimulus presen. Left,right, binauralOutput: Headset TDH39	Same audio stimulator	None
Visual Stimulator	Led Flash Stimulator(optional - same deviceas BE Plus LTM)	None	Led Flash Stimulator(optional)

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807.92(b)(1)

Summary of Non-Clinical Tests

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.

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

The Nemus 2 is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.

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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2014

EB Neuro, S.p.A. c/o Ms. Allison Scott, RAC Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268

Re: K133517

Trade/Device Name: Nemus 2 System Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL Additional procodes: GWF, GWE, GWJ Dated: January 20, 2014 Received: January 22, 2014

Dear Ms. Scott:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Allison Scott, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological And Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133517

Device Name Nemus 2 System

Indications for Use (Describe)

The Nemus 2 System is intended to acquire the bioced by the patient's central and peripheral nervous system and nuscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The Nenus 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 compaibility of the Nemus 2 System to the other components of the user's own system.

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)

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)

Jovce N

Regulation Number and Section

§ 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).