NExT Station; NExT Station Advanced
Device Facts
| Record ID | K242832 |
|---|---|
| Device Name | NExT Station; NExT Station Advanced |
| Applicant | Eb Neuro S.P.A. |
| Product Code | GWL · Neurology |
| Decision Date | Dec 12, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1835 |
| Device Class | Class 2 |
Indications for 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.
Device Story
NExT Station and NExT Station Advanced are physiological signal amplifiers for EMG and EP exams. Devices acquire bioelectric signals from central/peripheral nervous systems and muscles; signals processed via Galileo NT Line software on a connected PC. System includes electrical, auditory, and photic stimulators for evoked response analysis. Available in mobile (cart-mounted) or portable (desktop) configurations. Operated by neurologists, neurophysiopathology technicians, anesthesiologists, neonatologists, and ICU nursing staff in hospital/clinical environments. Output displayed on PC for clinical review; aids diagnosis and monitoring of nervous system/muscle disorders. Benefits include integrated signal acquisition, stimulation, and analysis platform.
Clinical Evidence
Bench testing only. Verification and validation testing performed for electrical, mechanical, and thermal safety (ANSI/AAMI ES60601-1), EMC (IEC 60601-1-2), and light safety (EN ISO 15004-2, EN 62471). Software verification performed at unit, integration, and system levels.
Technological Characteristics
Physiological signal amplifier; 4 EMG channels (NExT Station) or 4 EMG/8 EP channels (NExT Station Advanced). 24-bit A/D conversion; >110 dB CMRR; >100 MΩ input impedance. Connectivity via wired LAN (Ethernet/IEEE 802.3). Powered by 115V medical power supply. Includes electrical, auditory, and photic stimulators. Software: Galileo NT Line (Windows-based). Patient isolation: BF type.
Indications for Use
Indicated for patients undergoing Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals from the central and peripheral nervous system and muscles for diagnosis and monitoring of potential disorders.
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
Submission Summary (Full Text)
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December 12, 2024
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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,
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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 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.
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 and<br>Manufacturer Name: | EB Neuro S.p.A. |
| Contact Person: | Name: Barry Ashar<br>Phone: 603.674.9074<br>Fax: |
| Device Information | |
| Trade Name: | NEXT Station and NEXT Station Advanced |
| Common Name: | Physiological Signal Amplifier |
| Classification and<br>Product Code: | 21 CFR 882.1835<br>GWL - Amplifier, Physiological Signal<br>Additional Product Codes:<br>OLT, IKN – EP and EMG<br>GWE, GWF, GWJ – Auditory, Photic and Electrical stimulators |
| Device Class: | Class II |
| Predicate Device: | K133517, Nemus 2 System (Hardware, amplifier) (GWL)<br>K142064, Galileo NT Software (OLT)<br>EB Neuro S.p.A.<br>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).<br><br>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.<br><br>Two versions are available depending on the support where the Medical Device is placed:<br>- “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.<br>- “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.<br><br>The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis. |
| Technological<br>Comparison | 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.<br><br>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 very<br>similar components and accessories. |
| | The basic operational procedures including system setup, patient<br>preparations, signal acquisition, data storage and analysis are identical<br>between the subject and predicate devices. |
| | Subject devices' technological characteristics remain the same as those of<br>the predicate devices. The following changes are made in the subject<br>devices compared to the predicate devices:<br>- Two predicate devices (one hardware, the other software)<br>previously cleared in their own separate 510(k)s are now being<br>combined together as the subject device, with the exact same<br>intended use as the ones of the predicate devices.<br>- Since the subject device now includes the software, it is provided<br>with accessories like PC, keyboard, mouse and screen. Everything<br>is mounted together on a cart or offered as a desktop setup. The<br>predicate hardware device didn't include these. The predicate<br>software device didn't include these as the user was asked to<br>install the software on any platform of their choice.<br>- The predicate hardware device had 2 EMG channels, the subject<br>device has 4 EMG channels.<br>- Some hardware components have been upgraded for better<br>performance, for example, better quality Low Pass Filter for<br>improved noise reduction.<br>- The predicate hardware device included one visual stimulator, the<br>subject device includes three visual stimulators to address user<br>needs. All visual stimulators have passed EMC and Light Safety<br>testing. |
| Basis for Equivalence | The subject devices are essentially a bundled together package of our<br>own previously cleared predicate devices, with the same intended use<br>and technological characteristics. The first predicate device Nemus 2 is<br>an EMG amplifier hardware and the second predicate device Galileo NT<br>is an EMG analysis software. They were previously 510(k) cleared on<br>their own and are now being bundled together as a full EMG system. |
| Performance Testing | Due to the enhancements made to the electronic and electrical<br>components, it was necessary to verify the electrical/mechanical/thermal<br>safety and electromagnetic compatibility (EMC) of the subject devices.<br>This was performed using the exact same test methods used for the<br>predicate device using FDA-recognized external standards ANSI/AAMI<br>ES60601-1 and IEC 60601-1-2. LED visual stimulators passed Light |
| Safety Testing performed in accordance with EN ISO 15004-2 (Light<br>Hazard Protection) and EN 62471 (Photobiological Safety of Lamps and<br>Lamp Systems). | |
| Incremental software enhancements and bug fixes in the subject devices<br>compared to the predicate devices were determined to not have any<br>safety or effective implications on the device. Each incremental released<br>version was subjected to verification testing, at unit, integration and/or<br>system level, as appropriate for the update in the scope of that version.<br>In addition, the subject devices of this 510(k) submission were subjected<br>to a complete and comprehensive V&V testing. | |
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| Item | Subject Devices | | Predicate Devices | | Comments |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | NEXT Station | NEXT Station<br>Advanced | Nemus 2<br>(K133517) | Galileo NT<br>(K142064) | |
| Intended Use | The NEXT Station and<br>NEXT Station<br>Advanced are<br>physiological signal<br>amplifiers intended to<br>be used during<br>Electromyography<br>(EMG) and Evoked<br>Potential (EP) exams to<br>acquire bioelectric<br>signals produced by the<br>patient's central and<br>peripheral nervous<br>system and muscles.<br>The devices include<br>Galileo NT Line<br>software to record and<br>display acquired data to<br>aid the diagnosis and<br>monitoring of potential<br>disorders of the central<br>and peripheral nervous<br>system and muscles.<br><br>The devices include an<br>electrical stimulator, an<br>auditory stimulator, and<br>a photic stimulator as | The NEXT Station and<br>NEXT Station<br>Advanced are<br>physiological signal<br>amplifiers intended to<br>be used during<br>Electromyography<br>(EMG) and Evoked<br>Potential (EP) exams to<br>acquire bioelectric<br>signals produced by the<br>patient's central and<br>peripheral nervous<br>system and muscles.<br>The devices include<br>Galileo NT Line<br>software to record and<br>display acquired data to<br>aid the diagnosis and<br>monitoring of potential<br>disorders of the central<br>and peripheral nervous<br>system and muscles.<br><br>The devices include an<br>electrical stimulator, an<br>auditory stimulator, and<br>a photic stimulator as | Medical Device<br>intended to acquire<br>bioelectric signals<br>produced by the<br>patient's central<br>and peripheral<br>nervous system<br>and muscles. The<br>acquired signals<br>are transmitted to a<br>PC during<br>recording of<br>neurophysiology<br>examinations.<br>The device may<br>use electrical<br>stimulus, sound<br>stimulus, or visual<br>stimulus for use in<br>evoked response<br>analysis. | Intended to<br>record and<br>display EEG,<br>Video-EEG,<br>LTM, PSG,<br>EMG, EP data<br>acquired from the<br>patient body<br>through EB<br>Neuro acquisition<br>platform, to aid<br>the diagnosis and<br>monitoring of<br>potential<br>disorders of the<br>central and<br>peripheral<br>nervous system<br>and muscles. | Similar. See Note<br>1. |
|--|
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| Item | Subject Devices | | Predicate Devices | | Comments |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | NExT Station | NExT Station<br>Advanced | Nemus 2<br>(K133517) | Galileo NT<br>(K142064) | |
| | accessories that may<br>optionally be used in<br>evoked response<br>analysis. | accessories that may<br>optionally be used in<br>evoked response<br>analysis. | | | |
| Intended Usage<br>Site | Hospital environments. | Hospital environments. | Hospitals,<br>laboratory,<br>institutions, or<br>other test<br>environments.<br>The device may be<br>placed in Intensive<br>Care Unit or<br>Operating Room<br>for continuous<br>recording. | The device is<br>intended to<br>be used in the<br>clinical and<br>hospital<br>environment<br>(including the<br>hospital<br>room, emergency<br>room, intensive<br>care unit, neuro-<br>intensive care<br>unit, critical care<br>unit). | Same |
| Intended User | Neurology physicians,<br>Neurophysiopathology<br>technicians under<br>physician's supervision,<br>other physicians such as<br>anesthesiologists,<br>neonatologists and<br>nursing staff of intensive<br>care unit. | Neurology physicians,<br>Neurophysiopathology<br>technicians under<br>physician's supervision,<br>other physicians such as<br>anesthesiologists,<br>neonatologists and<br>nursing staff of intensive<br>care unit. | The user can only<br>be on the order of a<br>physician. | This device is<br>intended to<br>be used by<br>qualified<br>medical<br>practitioners who<br>will exercise<br>professional<br>judgment in using<br>the information. | Same |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | NExT Station | NExT Station<br>Advanced | Nemus 2<br>(K133517) | Galileo NT<br>(K142064) | |
| System<br>Configuration | It is a signal acquisition<br>device connected to a PC<br>with Galileo NT software<br>running on the PC. It can<br>be placed on a trolley<br>(mobile version) or on a<br>desk (portable version). | It is a signal acquisition<br>device connected to a PC<br>with Galileo NT software<br>running on the PC. It can<br>be placed on a trolley<br>(mobile version) or on a<br>desk (portable version). | It is a signal<br>acquisition device<br>intended to be<br>connected to a PC<br>with Galileo NT<br>software running on<br>the PC. The PC can<br>be placed on a<br>trolley (mobile<br>version) or on a desk<br>(portable version). | It is a software<br>only device,<br>deployed on a<br>Windows-based<br>PC. | Similar. See Note<br>2. |
| Power Supply | 115 V medical power<br>supply. | 115 V medical power<br>supply. | 115 V medical<br>power supply. | N/A | Same |
| Components and<br>Accessories | Acquisition and<br>stimulation modules<br>Medical AC/DC<br>adapter<br>LAN connection<br>LAN isolator<br>Electrical, visual and<br>audio stimulators<br>Windows PC<br>Keyboard, mouse,<br>printer<br>Trolley<br>Cables | Acquisition and<br>stimulation modules<br>Medical AC/DC<br>adapter<br>LAN connection<br>LAN isolator<br>Electrical, visual and<br>audio stimulators<br>Windows PC<br>Keyboard, mouse,<br>printer<br>Trolley<br>Cables | Acquisition and<br>stimulation<br>modules<br>Medical AC/DC<br>adapter<br>LAN connection<br>Electrical, visual<br>and audio<br>stimulators<br>Cables | Software<br>intended to be<br>deployed on a PC<br>equipped with<br>keyboard, mouse,<br>printer, and<br>mounted on a<br>desktop or<br>trolley. | Similar. See Note<br>3. |
| Computer | Desktop PC<br>Laptop PC | Desktop PC<br>Laptop PC | Intended for:<br>Desktop PC<br>Laptop PC | Intended for:<br>Desktop PC<br>Laptop PC | Same |
| Operating<br>System | 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:<br>"wired LAN "<br>ETHERNET/IEEE 802.3 | TCP/IP link on:<br>"wired LAN "<br>ETHERNET/IEEE 802.3 | TCP/IP link on:<br>"wired LAN "<br>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<br>(synchronization<br>to external<br>signal) | TTL LEVEL – negative slope | TTL LEVEL – negative slope | TTL LEVEL – negative slope | N/A | Same |
| Trigger Output<br>(synchronization<br>for external<br>signal) | 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 Amplifier<br>190 (L) x 150 (W) x 60<br>(H) (mm) | NExT-AMP Advanced<br>Amplifier<br>190 (L) x 150 (W) x 60<br>(H) (mm) | NeMus 2 Base<br>Unit<br>170 (L) x 125 (W)<br>x 35 (H) (mm) | N/A | Similar values |
| Device Weight | NExT-AMP Amplifier<br>~1 Kg | NExT-AMP Advanced<br>Amplifier ~1 Kg | NeMus 2 Base<br>Unit 0.6 Kg | N/A | Similar values |
| Design - Acquisition |…
