The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.

The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.

Device Description

EMG Family devices (NEXT Station and NEXT Station Advanced) are capable of detecting electrical signals produced by the central and peripheral nervous systems and by striated muscles. In connection with a PC, where the Galileo NT Line software is installed, they allow to perform both spontaneous and evoked electromyographic activity easily and in all their phases. Their fields of application are Electromyography (EMG) and Evoked Potentials (EP).

EB Neuro EMG Family devices include all the elements necessary for the acquisition of neurographic signals, for their analog-digital conversion and pre-processing, for audio monitoring, for the delivery of electrical, acoustic and visual stimulation. The functions of user interface, presentation, post-processing, storage, signals archiving and printing and data extracted from them are managed by a PC installed with the Galileo NT Line software.

Two versions are available depending on the support where the Medical Device is placed:

“Mobile” is a mobile device placed on a cart, powered at 115V by Isolation Transformer and connected with a PC with Galileo NT Line medical device software running on the PC.
“Portable” is a portable device placed on a desk, powered at 115V by medical power supply and connected with a PC with Galileo NT Line medical device software running on a Laptop PC.

AI/ML Overview

This FDA 510(k) summary (K242832) for the EB Neuro S.p.A. NExT Station and NExT Station Advanced devices focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against predefined acceptance criteria for a new clinical claim. The summary explicitly states that:

"The subject devices are essentially a bundled together package of our own previously cleared predicate devices. The first predicate device Nemus 2 is an EMG amplifier hardware and the second predicate device Galileo NT is an EMG analysis software. They were previously 510(k) cleared on their own and are now being bundled together as a full EMG system.

No new features are added to the subject devices compared to the predicate devices. The subject devices essentially have the same design as the predicate devices."

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication, and MRMC studies is not applicable in the context of this 510(k) submission. The submission's primary purpose is to show that the new combined device performs substantially similarly to its already-cleared components and does not introduce new safety or effectiveness concerns.

However, I can extract information related to the device's technical specifications and the testing performed to ensure it meets general safety and performance standards relevant to medical devices:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a bundled device with "no new features" in terms of clinical performance, there isn't a table of clinical acceptance criteria vs. device performance in the traditional sense of a de novo device. Instead, the acceptance criteria are met by demonstrating compliance with recognized standards and equivalence in technical specifications to the predicate devices. The performance is assessed against these standards and predicate device specifications.

Feature/Standard	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (NExT Station / NExT Station Advanced)	Comments on Performance
Intended Use	Same as combined predicate devices.	"The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles. The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis."	Declared identical or combined from predicates.
Intended Usage Site	Hospitals, laboratory, institutions, or other test environments. Intensive Care Unit or Operating Room for continuous recording.	Hospital environments.	Same as predicate.
Intended User	Qualified medical practitioners (Neurology physicians, Neurophysiopathology technicians under physician's supervision, other physicians, nursing staff).	Neurology physicians, Neurophysiopathology technicians under physician's supervision, other physicians such as anesthesiologists, neonatologists and nursing staff of intensive care unit.	Same as predicate.
System Configuration	Signal acquisition device connected to a PC with Galileo NT software, placed on trolley or desk.	Signal acquisition device connected to a PC with Galileo NT software running on the PC. It can be placed on a trolley (mobile version) or on a desk (portable version).	Similar; combined from predicates.
Power Supply	115 V medical power supply.	115 V medical power supply.	Same as predicate.
Computer	Desktop PC or Laptop PC.	Desktop PC, Laptop PC.	Same as predicate.
Operating System	Windows.	Windows.	Same as predicate.
Software	Resident and runtime downloadable.	Resident and runtime downloadable.	Same as predicate.
Communication Protocol	TCP/IP link on "wired LAN" ETHERNET/IEEE 802.3.	TCP/IP link on "wired LAN" ETHERNET/IEEE 802.3.	Same as predicate.
Signal Acquisition	Analog to digital conversion at variable sampling rate.	Analog to digital conversion at variable sampling rate.	Same as predicate.
Trigger Input	TTL LEVEL – negative slope.	TTL LEVEL – negative slope.	Same as predicate.
Trigger Output	TTL signal - active high, 20us duration.	TTL signal - active high, 20us duration.	Same as predicate.
Patient Circuitry Isolation	Patient isolation BF type.	Patient isolation BF type.	Same as predicate.
Measurement Principle	Acquisition of physiological signal elaborated on Host PC software.	Acquisition of the physiological signal that is subsequently elaborated on the software on Host PC.	Same as predicate.
Number of Channels (EMG)	Nemus 2: 2 EMG channels	NExT Station: 4 EMG channels NExT Station Advanced: 4 EMG channels	Increased. "Difference in the number and type of channels address different market needs and preferences, they do not raise any additional questions of safety or effectiveness."
Number of Channels (EP)	Nemus 2: 20 EP channels	NExT Station: N/A NExT Station Advanced: 8 EP channels	Different. "Difference in the number and type of channels address different market needs and preferences, they do not raise any additional questions of safety or effectiveness."
CMRR	> 100 dB (Predicate Nemus 2)	> 110 dB	Improved (higher is better). Meets or exceeds predicate.
Noise	< 0.3 µVrms (0.1 - 100 Hz) (Predicate Nemus 2)	< 0.4 µVrms (0.1Hz - 10kHz); < 0.02 µVrms (0.1Hz - 30Hz)	Similar values, frequency range differs. Considered similar.
Differential Input Impedance	> 100 MΩ.	> 100 MΩ.	Same as predicate.
Low Pass Filter	20 KHz (Predicate Nemus 2)	10 KHz	Lower. "Subject devices remove high frequency components for effective removal of noise and artifacts." This is presented as an enhancement.
High Pass Filter	Selectable 0.1 Hz or 10 Hz (Predicate Nemus 2)	0.1 Hz	Different options. "Subject devices remove high frequency components for effective removal of noise and artifacts."
A/D Conversion (EMG)	24 bit (Predicate Nemus 2)	24 bit	Same as predicate.
A/D Conversion (EP)	16 bit (Predicate Nemus 2)	24 bit (NExT Station Advanced)	Improved (higher resolution).
Sampling Rate	32768 Hz (EMG ch); 16384 Hz (EP ch) (Predicate Nemus 2)	Adjustable: 2048, 4096, 8192, 16384, 32768, 65536 Hz	Higher maximum sampling frequency. "Subject devices have maximum sampling frequency higher than predicate devices, ensuring a higher fidelity digitization."
Electrical Stimulation - No. of Outputs	1 (Predicate Nemus 2)	2	Increased. "Additional stimulation output on the subject devices has no impact on safety or effectiveness."
Electrical, Mechanical and Thermal Safety	Compliance with ANSI AAMI 60601-1.	Complies with ANSI AAMI 60601-1.	Compliance demonstrated.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2.	Complies with IEC 60601-1-2.	Compliance demonstrated.
EMG and EP Requirements	Compliance with IEC 60601-2-40.	Complies with IEC 60601-2-40.	Compliance demonstrated.
Light Hazard Protection	Compliance with EN ISO 15004-2.	Complies with EN ISO 15004-2.	Compliance demonstrated for new visual stimulators.
Photobiological Safety of Lamps and Lamp Systems	Compliance with EN 62471.	Complies with EN 62471.	Compliance demonstrated for new visual stimulators.
Medical Device Software	Compliance with IEC 62304.	Complies with IEC 62304.	Compliance demonstrated.
Medical Device Risk Management	Compliance with ISO 14971.	Complies with ISO 14971.	Compliance demonstrated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not discuss a clinical test set or data provenance in the context of diagnostic performance. The "testing" mentioned refers to engineering verification and validation (V&V) to ensure compliance with standards and the predicate device's technical specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as there was no clinical study comparing device findings to a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physiological signal amplifier and software system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a measurement and display system for physiological signals, intended for use by qualified medical professionals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The performance is assessed against technical standards and the specifications of predicate devices, not against a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device requiring a training set for algorithm development.

9. How the ground truth for the training set was established

Not applicable.

Summary

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December 12, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

EB Neuro S.p.A. % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079

Re: K242832

Trade/Device Name: NExT Station; NExT Station Advanced Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, OLT, IKN, GWE, GWF, GWJ Dated: November 12, 2024 Received: November 12, 2024

Dear Barry Ashar:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Image /page/2/Picture/3 description: The image contains the text "Patrick Antkowiak -S" in a simple, sans-serif font. To the left of the text is a faded, stylized logo that appears to be the letters "FDA". The text is arranged vertically, with "Patrick" on the top line, "Antkowiak" on the second line, and "-S" on the third line. The overall impression is clean and professional.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242832

Device Name NExT Station NExT Station Advanced

Indications for Use (Describe)

The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K242832

Special 510(k) SUMMARY NExT Station and NExT Station Advanced

Date Prepared:	October 18, 2024
Submitter Information
Company andManufacturer Name:	EB Neuro S.p.A.
Contact Person:	Name: Barry AsharPhone: 603.674.9074Fax:
Device Information
Trade Name:	NEXT Station and NEXT Station Advanced
Common Name:	Physiological Signal Amplifier
Classification andProduct Code:	21 CFR 882.1835GWL - Amplifier, Physiological SignalAdditional Product Codes:OLT, IKN – EP and EMGGWE, GWF, GWJ – Auditory, Photic and Electrical stimulators
Device Class:	Class II
Predicate Device:	K133517, Nemus 2 System (Hardware, amplifier) (GWL)K142064, Galileo NT Software (OLT)EB Neuro S.p.A.21 CFR 882.1835
Device Description	EMG Family devices (NEXT Station and NEXT Station Advanced) are capable of detecting electrical signals produced by the central and peripheral nervous systems and by striated muscles. In connection with a PC, where the Galileo NT Line software is installed, they allow to perform both spontaneous and evoked electromyographic activity easily and in all their phases. Their fields of application are Electromyography (EMG) and Evoked Potentials (EP).EB Neuro EMG Family devices include all the elements necessary for the acquisition of neurographic signals, for their analog-digital conversion and pre-processing, for audio monitoring, for the delivery of electrical, acoustic and visual stimulation. The functions of user interface, presentation, post-processing, storage, signals archiving and printing and data extracted from them are managed by a PC installed with the Galileo NT Line software.Two versions are available depending on the support where the Medical Device is placed:- “Mobile” is a mobile device placed on a cart, powered at 115V by Isolation Transformer and connected with a PC with Galileo NT Line medical device software running on the PC.- “Portable” is a portable device placed on a desk, powered at 115V by medical power supply and connected with a PC with Galileo NT Line medical device software running on a Laptop PC.
Intended Use:	The NEXT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.
TechnologicalComparison	The subject devices are essentially a bundled together package of our own previously cleared predicate devices. The first predicate device Nemus 2 is an EMG amplifier hardware and the second predicate device Galileo NT is an EMG analysis software. They were previously 510(k) cleared on their own and are now being bundled together as a full EMG system.No new features are added to the subject devices compared to the predicate devices. The subject devices essentially have the same design as
	the predicate devices. Both the subject and predicate devices use verysimilar components and accessories.
	The basic operational procedures including system setup, patientpreparations, signal acquisition, data storage and analysis are identicalbetween the subject and predicate devices.
	Subject devices' technological characteristics remain the same as those ofthe predicate devices. The following changes are made in the subjectdevices compared to the predicate devices:- Two predicate devices (one hardware, the other software)previously cleared in their own separate 510(k)s are now beingcombined together as the subject device, with the exact sameintended use as the ones of the predicate devices.- Since the subject device now includes the software, it is providedwith accessories like PC, keyboard, mouse and screen. Everythingis mounted together on a cart or offered as a desktop setup. Thepredicate hardware device didn't include these. The predicatesoftware device didn't include these as the user was asked toinstall the software on any platform of their choice.- The predicate hardware device had 2 EMG channels, the subjectdevice has 4 EMG channels.- Some hardware components have been upgraded for betterperformance, for example, better quality Low Pass Filter forimproved noise reduction.- The predicate hardware device included one visual stimulator, thesubject device includes three visual stimulators to address userneeds. All visual stimulators have passed EMC and Light Safetytesting.
Basis for Equivalence	The subject devices are essentially a bundled together package of ourown previously cleared predicate devices, with the same intended useand technological characteristics. The first predicate device Nemus 2 isan EMG amplifier hardware and the second predicate device Galileo NTis an EMG analysis software. They were previously 510(k) cleared ontheir own and are now being bundled together as a full EMG system.
Performance Testing	Due to the enhancements made to the electronic and electricalcomponents, it was necessary to verify the electrical/mechanical/thermalsafety and electromagnetic compatibility (EMC) of the subject devices.This was performed using the exact same test methods used for thepredicate device using FDA-recognized external standards ANSI/AAMIES60601-1 and IEC 60601-1-2. LED visual stimulators passed Light
Safety Testing performed in accordance with EN ISO 15004-2 (LightHazard Protection) and EN 62471 (Photobiological Safety of Lamps andLamp Systems).
Incremental software enhancements and bug fixes in the subject devicescompared to the predicate devices were determined to not have anysafety or effective implications on the device. Each incremental releasedversion was subjected to verification testing, at unit, integration and/orsystem level, as appropriate for the update in the scope of that version.In addition, the subject devices of this 510(k) submission were subjectedto a complete and comprehensive V&V testing.

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Item	Subject Devices		Predicate Devices		Comments
	NEXT Station	NEXT StationAdvanced	Nemus 2(K133517)	Galileo NT(K142064)
Intended Use	The NEXT Station andNEXT StationAdvanced arephysiological signalamplifiers intended tobe used duringElectromyography(EMG) and EvokedPotential (EP) exams toacquire bioelectricsignals produced by thepatient's central andperipheral nervoussystem and muscles.The devices includeGalileo NT Linesoftware to record anddisplay acquired data toaid the diagnosis andmonitoring of potentialdisorders of the centraland peripheral nervoussystem and muscles.The devices include anelectrical stimulator, anauditory stimulator, anda photic stimulator as	The NEXT Station andNEXT StationAdvanced arephysiological signalamplifiers intended tobe used duringElectromyography(EMG) and EvokedPotential (EP) exams toacquire bioelectricsignals produced by thepatient's central andperipheral nervoussystem and muscles.The devices includeGalileo NT Linesoftware to record anddisplay acquired data toaid the diagnosis andmonitoring of potentialdisorders of the centraland peripheral nervoussystem and muscles.The devices include anelectrical stimulator, anauditory stimulator, anda photic stimulator as	Medical Deviceintended to acquirebioelectric signalsproduced by thepatient's centraland peripheralnervous systemand muscles. Theacquired signalsare transmitted to aPC duringrecording ofneurophysiologyexaminations.The device mayuse electricalstimulus, soundstimulus, or visualstimulus for use inevoked responseanalysis.	Intended torecord anddisplay EEG,Video-EEG,LTM, PSG,EMG, EP dataacquired from thepatient bodythrough EBNeuro acquisitionplatform, to aidthe diagnosis andmonitoring ofpotentialdisorders of thecentral andperipheralnervous systemand muscles.	Similar. See Note1.

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Item	Subject Devices		Predicate Devices		Comments
	NExT Station	NExT StationAdvanced	Nemus 2(K133517)	Galileo NT(K142064)
	accessories that mayoptionally be used inevoked responseanalysis.	accessories that mayoptionally be used inevoked responseanalysis.
Intended UsageSite	Hospital environments.	Hospital environments.	Hospitals,laboratory,institutions, orother testenvironments.The device may beplaced in IntensiveCare Unit orOperating Roomfor continuousrecording.	The device isintended tobe used in theclinical andhospitalenvironment(including thehospitalroom, emergencyroom, intensivecare unit, neuro-intensive careunit, critical careunit).	Same
Intended User	Neurology physicians,Neurophysiopathologytechnicians underphysician's supervision,other physicians such asanesthesiologists,neonatologists andnursing staff of intensivecare unit.	Neurology physicians,Neurophysiopathologytechnicians underphysician's supervision,other physicians such asanesthesiologists,neonatologists andnursing staff of intensivecare unit.	The user can onlybe on the order of aphysician.	This device isintended tobe used byqualifiedmedicalpractitioners whowill exerciseprofessionaljudgment in usingthe information.	Same
Item	Subject Devices		Predicate Devices		Comments
	NExT Station	NExT StationAdvanced	Nemus 2(K133517)	Galileo NT(K142064)
SystemConfiguration	It is a signal acquisitiondevice connected to a PCwith Galileo NT softwarerunning on the PC. It canbe placed on a trolley(mobile version) or on adesk (portable version).	It is a signal acquisitiondevice connected to a PCwith Galileo NT softwarerunning on the PC. It canbe placed on a trolley(mobile version) or on adesk (portable version).	It is a signalacquisition deviceintended to beconnected to a PCwith Galileo NTsoftware running onthe PC. The PC canbe placed on atrolley (mobileversion) or on a desk(portable version).	It is a softwareonly device,deployed on aWindows-basedPC.	Similar. See Note2.
Power Supply	115 V medical powersupply.	115 V medical powersupply.	115 V medicalpower supply.	N/A	Same
Components andAccessories	Acquisition andstimulation modulesMedical AC/DCadapterLAN connectionLAN isolatorElectrical, visual andaudio stimulatorsWindows PCKeyboard, mouse,printerTrolleyCables	Acquisition andstimulation modulesMedical AC/DCadapterLAN connectionLAN isolatorElectrical, visual andaudio stimulatorsWindows PCKeyboard, mouse,printerTrolleyCables	Acquisition andstimulationmodulesMedical AC/DCadapterLAN connectionElectrical, visualand audiostimulatorsCables	Softwareintended to bedeployed on a PCequipped withkeyboard, mouse,printer, andmounted on adesktop ortrolley.	Similar. See Note3.
Computer	Desktop PCLaptop PC	Desktop PCLaptop PC	Intended for:Desktop PCLaptop PC	Intended for:Desktop PCLaptop PC	Same
OperatingSystem	Windows	Windows	Windows	Windows	Same
Item	Subject Devices		Predicate Devices		Comments
	NExT Station	NExT Station Advanced	Nemus 2 (K133517)	Galileo NT (K142064)
Software	Resident and runtime downloadable.	Resident and runtime downloadable.	Resident and runtime downloadable.	Resident and runtime downloadable.	Same
Communication Protocol	TCP/IP link on:"wired LAN "ETHERNET/IEEE 802.3	TCP/IP link on:"wired LAN "ETHERNET/IEEE 802.3	TCP/IP link on:"wired LAN "ETHERNET/IEEE 802.3	N/A	Same
Signal Acquisition	Analog to digital conversion at variable sampling rate	Analog to digital conversion at variable sampling rate	Analog to digital conversion at variable sampling rate	N/A	Same
Trigger Input(synchronizationto externalsignal)	TTL LEVEL – negative slope	TTL LEVEL – negative slope	TTL LEVEL – negative slope	N/A	Same
Trigger Output(synchronizationfor externalsignal)	TTL signal - active high, 20us duration	TTL signal - active high, 20us duration	TTL signal - active high, 20us duration	N/A	Same
Patient Circuitry Isolation	Patient isolation BF type	Patient isolation BF type	Patient isolation BF type	N/A	Same
Device Dimensions	NExT-AMP Amplifier190 (L) x 150 (W) x 60(H) (mm)	NExT-AMP AdvancedAmplifier190 (L) x 150 (W) x 60(H) (mm)	NeMus 2 BaseUnit170 (L) x 125 (W)x 35 (H) (mm)	N/A	Similar values
Device Weight	NExT-AMP Amplifier~1 Kg	NExT-AMP AdvancedAmplifier ~1 Kg	NeMus 2 BaseUnit 0.6 Kg	N/A	Similar values
Design - Acquisition
Measurement Principle	The device providesacquisition of the	The device providesacquisition of the	The device provides	N/A	Same
Item	Subject Devices		Predicate Devices		Comments
	NExT Station	NExT StationAdvanced	Nemus 2(K133517)	Galileo NT(K142064)
	physiological signalthat is subsequentlyelaborated on thesoftware on Host PC.	physiological signalthat is subsequentlyelaborated on thesoftware on Host PC.	acquisition of thephysiologicalsignal that issubsequentlyelaborated on thesoftware on HostPC.
Number ofChannels	4 EMG channels	4 EMG channels8 EP channels	2 EMG channels20 EP channels	N/A	Similar. See Note4.
CMRR	>110 dB	> 110 dB	> 100 dB	N/A	Same
Noise	< 0,4 $\mu$ Vrms (0,1Hz -10kHz)< 0,02 $\mu$ Vrms (0,1Hz -30Hz)	< 0,4 $\mu$ Vrms (0,1Hz -10kHz)< 0,02 $\mu$ Vrms (0,1Hz -30Hz)	< 0.3 $\mu$ Vrms (0.1 -100 Hz)	N/A	Similar values.
DifferentialInput Impedance	> 100 ΜΩ	> 100 ΜΩ	> 100 ΜΩ	N/A	Same
Low Pass Filter	10 KHz	10 KHz	20 KHz	N/A	Similar values.
High Pass Filter	0.1 Hz	0.1 Hz	Selectable 0.1 Hzor 10 Hz	N/A	See Note 5.
A/D Conversion	EMG channels: 24 bit	EMG channels: 24 bitEP channels: 24 bit	EMG channels: 24bitEP channels: 16 bit	N/A	Similar values.See Note 6.
Sampling Rate	Adjustable: 2048, 4096,8192, 16384, 32768,65536 Hz	Adjustable: 2048, 4096,8192, 16384, 32768,65536 Hz	32768 Hz (EMGch)16384 Hz (EP ch)	N/A	Similar values.See Note 7.
Trigger Mode	Free, Auto, Internal,External	Free, Auto, Internal,External	Free, Auto,Internal, External	N/A	Same
Ohmmeter	Measurement of theimpedance in allbioelectric channels in	Measurement of theimpedance in allbioelectric channels in	Measurement ofthe impedance inall bioelectric	N/A	Same
Item	Subject Devices	Subject Devices	Predicate Devices	Predicate Devices	Comments
	NExT Station	NExT StationAdvanced	Nemus 2(K133517)	Galileo NT(K142064)
	the range 1-100 KOhmwith precision of +/-10%	the range 1-100 KOhmwith precision of +/-10%	channels in therange 1-100 KOhmwith precision of+/- 10%
	Electrical Stimulation
Somatosensory(electrical)stimulator	Yes	Yes	Yes	N/A	Same
Type	Constant Current	Constant Current	Constant Current	N/A	Same
No. of Outputs	2	2	1	N/A	Similar values.See Note 8.
Max Output	100 mA	100 mA	100 mA	N/A	Same
Pulse Width	0.05 - 1 ms	0.05 - 1 ms	0.05 - 1 ms	N/A	Same
Mode	Single, train	Single, train	Single, train	N/A	Same
	Acoustic Stimulation
Audiostimulator	Yes	Yes	Yes	N/A	Same
Output mode	Tone, click or noise	Tone, click or noise	Tone, click ornoise	N/A	Same
Sound pressure	Tone/click:32-132 dB SPLNoise:[-40 to +10] dB REL	Tone/click:32-132 dB SPLNoise:[-40 to +10] dB REL	Tone/click:32-132 dB SPLNoise:[-40 to +10] dBREL	N/A	Same
Phase	Compressed / Rarefied /Alternating	Compressed / Rarefied /Alternating	Compressed /Rarefied /Alternating	N/A	Same
Signalfrequency	125-8000 Hz	125-8000 Hz	125-8000 Hz	N/A	Same
Click width	20-1000 us	20-1000 us	1-100 us	N/A	Similar values.
Item	Subject Devices		Predicate Devices		Comments
	NExT Station	NExT StationAdvanced	Nemus 2(K133517)	Galileo NT(K142064)
Stimulus	Left, right, binaural	Left, right, binaural	Left, right, binaural	N/A	Same
Visual Stimulation
VisualStimulator	- Flash LEDStimulator- Lens GogglesStimulator II- Pattern Monitor	- Flash LEDStimulator- Lens GogglesStimulator II- Pattern Monitor	- Flash LEDStimulator	N/A	Similar. See Note9.
Performance Standards
Electrical,Mechanical andThermal Safety	ANSI AAMI 60601-1	ANSI AAMI 60601-1	ANSI AAMI 60601-1	N/A	Same
ElectromagneticCompatibility	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2	N/A	Same
EMG and EPRequirements	IEC 60601-2-40	IEC 60601-2-40	IEC 60601-2-40	N/A	Same
Light HazardProtection	EN ISO 15004-2	EN ISO 15004-2	EN ISO 15004-2	N/A	Same
PhotobiologicalSafety of Lampsand LampSystems	EN 62471	EN 62471	EN 62471	N/A	Same
Medical DeviceSoftware	IEC 62304	IEC 62304	IEC 62304	IEC 62304	Same
Medical DeviceRiskManagement	ISO 14971	ISO 14971	ISO 14971	ISO 14971	Same

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Note 1: The subject devices are essentially a bundled package of the two predicate devices. As a result, their intended use is a combination of the intended uses of the predicate devices.

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Note 2: The subject devices are essentially a bundled package of the two predicate devices. As a result, their system onfiguration is a combination of the system configuration of the predicate devices.

Note 3: The subject devices are essentially a bundled package of the two predicate devices. As a result, their components and accessories are a combination of the components and accessories of the predicate devices.

Note 4: Difference in the number and type of channels address different market needs and preferences, they do not raise any additional questions of safety or effectiveness.

Note 5: Subject devices remove high frequency components for effective removal of noise and artifacts..

Note 6: Subject devices have same EMG A/D conversion resolution, have higher EP A/D conversion resolution.

Note 7: Subject devices have maximum sampling frequency higher than predicate devices, ensuring a higher fidelity digitization.

Note 8: Additional stimulation output on the subject devices has no impact on safety or effectiveness.

Note 9: Additional optional visual stimulators available with the subject devices were tested and verified to conform to the EMC requirements of IEC 60601-1-2 requirements as well as to the Light Safety requirements of EN ISO 15004-2 and EN 62471. They have no impact on safety or effectiveness.

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CONCLUSION

The subject devices (NExT Station and NExT Station Advanced) and the predicate devices (Nemus 2 and Galileo NT) have identical intended use /indication for use. The subject devices are essentially a bundled together package of previously cleared predicate devices. The first predicate device Nemus 2 is an EMG amplifier hardware and the second predicate device Galileo NT is an EMG analysis software. They were previously 510(k) cleared on their own and are being bundled together as a full EMG system.

Subject devices' technological characteristics remain the same as those of the predicate devices. The basic operational procedures including system setup, patient preparations, signal acquisition. data storage and analysis are identical between the subject and predicate devices.

Both the subject and predicate device use very similar components and accessories. The differences in their configurations due to the enhancements listed in section 12.5 above do not have any impact on the safety and effectiveness of the subject device.

The subject devices do not introduce any new safety considerations in comparison to the predicate devices. All identified differences between the two systems are minor and without any known impact on safety or efficacy.

Based on the information and supporting documentation provided in this premarket notification, the subject devices (NExT Station and NExT Station Advanced) are substantially equivalent to the cited predicate devices (Nemus 2 and Galileo NT).

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).