BE Plus PRO, Neurotravel LIGHT

K242305 · Eb Neuro S.P.A. · GWL · Sep 4, 2024 · Neurology

Device Facts

• Record ID: K242305
• Device Name: BE Plus PRO, Neurotravel LIGHT
• Applicant: Eb Neuro S.P.A.
• Product Code: GWL · Neurology
• Decision Date: Sep 4, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1835
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

BE Plus PRO and Neurotravel LIGHT are intended to be used for Electroencephalography (EEG) and Polysomnography (PSG) exams, in combination with the Galileo NT Line software, for human beings to assist the user in diagnosis and monitoring of disorders of the central and peripheral nervous system and muscles.

Device Story

BE Plus PRO and Neurotravel LIGHT are physiological signal amplifiers for EEG and PSG. Devices acquire bioelectric signals from cerebral cortex neurons via electrodes; signals are filtered, digitized by high-resolution analog-to-digital converters, and transmitted to a host PC via USB, Ethernet, or Wi-Fi. The Galileo NT Line software on the PC provides visualization, measurement, processing, and storage of brain signals. Used in clinical settings (hospitals, diagnostic centers, research labs) by neurologists, technicians, and ICU staff. Output allows clinicians to diagnose and monitor nervous system and muscle disorders. Configurations include mobile (trolley) and portable (desktop).

Clinical Evidence

Bench testing only. Verification of electrical, mechanical, and thermal safety and electromagnetic compatibility (EMC) performed using FDA-recognized standards ANSI/AAMI ES60601-1 and IEC 60601-1-2. No clinical data presented.

Technological Characteristics

Physiological signal amplifier; 22-34 monopolar/4-12 bipolar channels (BE Plus PRO) or 32 monopolar/8 bipolar (Neurotravel LIGHT). 24-bit ΣΔ ADC for EEG channels. Connectivity: USB, Ethernet, Wi-Fi. Power: 115V medical supply/internal battery. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 62304, ISO 14971. Patient isolation: BF type. Form factor: Mobile trolley or portable desktop.

Indications for Use

Indicated for human beings requiring EEG and PSG exams to assist in the diagnosis and monitoring of central and peripheral nervous system and muscle disorders. Used by neurology physicians, neurophysiopathology technicians, anesthesiologists, neonatologists, and ICU nursing staff.

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

• BE Plus LTM (K121996)
• Galileo NT Software (K142064)

Submission Summary (Full Text)

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September 4, 2024

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

Re: K242305

Trade/Device Name: BE Plus PRO, Neurotravel LIGHT Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GWQ, OLT, OLV Dated: July 24, 2024 Received: August 5, 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" (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).

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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 QS 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-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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Jay R. Gupta -S

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) K242305

Device Name BE Plus PRO Neurotravel LIGHT

#### Indications for Use (Describe)

BE Plus PRO and Neurotravel LIGHT are intended to be used for Electroencephalography (EEG) and Polysomnography (PSG) exams, in combination with the Galileo NT Line software, for human beings to assist the user in diagnosis and monitoring of disorders of the central and peripheral nervous system and muscles.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) #:

## 510(k) Summary

Prepared on: 2024-09-04

### Contact Details

21 CFR 807.92(a)(1)

21 CFR 807.92(a)(2)

| Applicant Name | EB Neuro S.p.A. |
|---------------------------------|---------------------------------------------|
| Applicant Address | Via P. Fanfani 97/A Firenze 50127 Italy |
| Applicant Contact Telephone | 390554565111 |
| Applicant Contact | Mr. Marco Rossi |
| Applicant Contact Email | [e-mail] |
| Correspondent Name | Makromed, Inc. |
| Correspondent Address | 88 Stiles Road Salem NH 03079 United States |
| Correspondent Contact Telephone | 6036749074 |
| Correspondent Contact | Mr. Barry Ashar |
| Correspondent Contact Email | [e-mail] |

### Device Name

BE Plus PRO; Device Trade Name Neurotravel LIGHT Common Name Physiological Signal Amplifier Physiological Signal Amplifier Classification Name 882 1835 Regulation Number GWL, GWQ, OLT, OLV Product Code(s)

| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|------------------------------------|----------------------------------------------------------|--------------|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K121996 | BE Plus LTM | GWL |
| K142064 | Galileo NT Software | OLT |

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EEG Family Devices

Device Description Summary

EEGFamily dovices (BE plus PRO and Noutratraval LKHT) are active medical devices composed of various parts necessary to allow tha achievement of their intended use. All thase parts are intended to be interconnected to achieve the specified medical purpose.

EEG Family devices can be used in patiations, diagnostics centers, neurosurgical hospitals and expenimental laboratorias of research institutions.

EEGFamily davices are capable of acquining the bioglectrics signal generated by the electrical potentials of the neurors of the carebral

cories, by maans of suitable signal, cidius alectrodes. This signal, of the order of a first and them, filtered to claim it of noise and offiet. It is then digitized by a high-resolution analog-to-digital converter at a cartain sampling rate.

The signals acquired and converted into digital format are transfarred to a Host PC through a special sanal communication with a declicated protocol and then can be processed by the Gallieo NT software to complete the intended use.

The software part allows the implements in of many specific functions of visualization, masurament, procass ing and storego of brain signals, acquired by the acquisition unit, based on the clinical area of interest.

EBG Family devices are offered in the following two configurations:

- Mobile: All components are mounted on a mobile trolley.

- Portable: All components are mounted on a stationary desktop.

Intended Use/Indications for Use

BE Plus PRO and Naurotravel LIGHT are intended to be used for Electronnephy (EEG) and Polysomnography(PSG) axams, in combination with the Galilao NTLine software, for human beings to assist the user in diegnosis and monitoring of disorders of the central and peripheral nervous system and muscles.

Indications for Use Comparison

The subject davices are essertially a bundled package of the two predicate davices. As a nesult, their intended use is a combination of the intended uses of the predicate devices.

### Technological Comparison

#### Introduction

The subject devices are essentially a bundled to gather package of our own proviously deared prodicated ories. The first prodicate device BE Plus LTM is an EEG amplifier hardware and the second predicate dating NF is an EEG analysis software. They won proviously 5108) daared on their own and are now being bunctied together as a full montage EEG davice.

#### Dasign

The subject devices essentially have the prodicate dovices. Both the subject and predicate devices use vary similar components and accessorias. That two subject davices are anhanced with observing and replacing cortain components of the producate dovice with state-of-the-art components.

Operational Charactanstics

The basic operations including system satup, patient proparations, signal acquisition, data storage and analysis are identical batwaan the subject and prodicate davices.

Tochnological Characteristics

Subject davices' technological characteristics remain the same as those of the predicate devices.

### Non-dinical Performance Characteristics

Dua to the enhancements made to the electrical components, it was necessary to wrify the electrical/mechanical/tharmal safety and ala ctromagnatic compat bility [EMO of the subjact devices. This was parformed using the exact same test mathods used for the prodicate device using FDA-recognized external standards ANSVAAMIES00601-1, EC 60601-1-2 and IEC 60601-2-20.

### Conclusion

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

### 21 CER 807 92(a)(4)

21 CFR 807.92(s)(5)

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| Item | Subject Devices | | Predicate Devices | | Comments |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM<br>(K121996) | Galileo NT<br>(K142064) | |
| Intended Use | | | | | |
| Intended Use | Medical Device<br>intended to be used for<br>Electroencephalography<br>(EEG), and<br>Polysomnography<br>(PSG) exams, in<br>combination with the<br>Galileo NT Line<br>software, for human<br>beings to assist the user<br>in diagnosis and<br>monitoring of disorder<br>of the central and<br>peripheral nervous<br>system and muscles. | Medical Device<br>intended to be used for<br>Electroencephalography<br>(EEG), and<br>Polysomnography<br>(PSG) exams, in<br>combination with the<br>Galileo NT Line<br>software, for human<br>beings to assist the user<br>in diagnosis and<br>monitoring of disorder<br>of the central and<br>peripheral nervous<br>system and muscles. | Acquisition of<br>EEG, polygraphy<br>and<br>polysomnography<br>signals and<br>transmission of<br>these to a PC<br>during recording of<br>neurophysiology<br>examinations. | 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. |
| Intended Usage<br>Site | Medical facilities with<br>environment and<br>electric network<br>compatible with EEG<br>usage standards. | Medical facilities with<br>environment and<br>electric network<br>compatible with EEG<br>usage standards. | Medical facilities<br>with environment<br>and electric<br>network<br>compatible with<br>EEG usage<br>standards. | The device is<br>intended to<br>be used in the<br>clinical and<br>hospital<br>environment<br>(including the<br>hospital | Same |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM<br>(K121996) | Galileo NT<br>(K142064) | |
| | | | | room, emergency<br>room, intensive<br>care unit, neuro-<br>intensive care<br>unit, critical care<br>unit). | |
| 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 “BE Plus<br>LTM / GWI”<br>amplifier system is<br>intended to be used<br>by or under<br>direction of a<br>physician for<br>acquisition of<br>EEG, polygraphy<br>and<br>polysomnography<br>signals and<br>transmission of<br>these signals to a<br>host PC during<br>recording of<br>neurophysiology<br>examinations. | 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 |
| Design - General | | | | | |
| 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 | 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 | It is a signal<br>acquisition device<br>intended to be<br>connected to a PC<br>with Galileo NT | It is a software<br>only device,<br>deployed on a<br>Windows-based<br>PC. | Similar. See Note<br>2. |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM<br>(K121996) | Galileo NT<br>(K142064) | |
| | (mobile version) or on a<br>desk (portable version). | (mobile version) or on a<br>desk (portable version). | 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). | | |
| Power Supply | 115 V medical power<br>supply and internal<br>battery. | 115 V medical power<br>supply. | 115 V medical<br>power supply and<br>internal battery. | N/A | Same |
| PC Connection | USB, Ethernet, Wi-Fi. | USB | USB, Ethernet, Wi-<br>Fi. | N/A | Same |
| Components and<br>Accessories | Flash LED stimulator<br>Pulse Oximeter module<br>Windows PC<br>Keyboard, mouse,<br>printer<br>Trolley<br>Batteries<br>Cables | Flash LED stimulator<br>Pulse Oximeter module<br>Windows PC<br>Keyboard, mouse,<br>printer<br>Trolley<br>Batteries<br>Cables | Flash LED<br>stimulator<br>Pulse Oximeter<br>module<br>Batteries<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>- Panel PC<br>- Laptop PC | - Desktop PC<br>- Panel PC<br>- Laptop PC | Intended for:<br>- Desktop PC<br>- Panel PC<br>- Laptop PC | Intended for:<br>- Desktop PC<br>- Panel PC<br>- Laptop PC | Same |
| Operating<br>System | Windows | Windows | Windows | Windows | Same |
| Software | Resident and runtime<br>downloadable. | Resident and runtime<br>downloadable. | Resident and<br>runtime<br>downloadable. | Resident and<br>runtime<br>downloadable. | Same |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM<br>(K121996) | Galileo NT<br>(K142064) | |
| Ports | 2 DC Link<br>1 USB Link<br>2 DC Out/Aux I/O | 1 USB Link<br>1 DC-AUX I/O | 2 DC Link<br>2 DC Out/Aux I/O | N/A | Similar. See Note<br>4. |
| Signal | Analog to digital<br>acquisition at variable<br>sampling rate | Analog to digital<br>acquisition at variable<br>sampling rate | Analog to digital<br>acquisition at<br>variable sampling<br>rate | N/A | Same |
| Trigger Input<br>(synchronization<br>to external<br>signal) | TTL LEVEL | TTL LEVEL | TTL LEVEL | N/A | Same |
| Trigger Output<br>(synchronization<br>for external<br>signal) | Flash LED Stimulator<br>is triggered by Galileo<br>NT Line software<br>running on host PC. | Flash LED Stimulator<br>is triggered by Galileo<br>NT Line software<br>running on host PC. | Flash LED<br>Stimulator is<br>triggered by<br>Galileo NT Line<br>software running<br>on host PC. | N/A | Same |
| Patient Circuitry<br>Isolation | Patient isolation BF<br>type | Patient isolation BF<br>type | Patient isolation<br>BF type | N/A | Same |
| Device<br>Dimensions | 120 (L) x 210 (W) x 48<br>(H) (mm) | 120 (L) x 174 (W) x 31<br>(H) (mm) | 170 (L) x 110 (W)<br>x 45 (H) (mm) | N/A | Similar values |
| Device Weight | 0.6 Kg | 0.3 Kg | 0.6 Kg | N/A | Similar values |
| Design - Acquisition | | | | | |
| Measurement<br>Principle | The device provides<br>acquisition of the<br>physiological signal<br>that is subsequently<br>elaborated on the<br>software on Host PC. | The device provides<br>acquisition of the<br>physiological signal<br>that is subsequently<br>elaborated on the<br>software on Host PC. | The device<br>provides<br>acquisition of the<br>physiological<br>signal that is<br>subsequently | N/A | Same |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM<br>(K121996) | Galileo NT<br>(K142064) | |
| | | | elaborated on the<br>software on Host<br>PC. | | |
| Number of<br>Channels | 22-34 monopolar<br>channels<br>4-12 bipolar channels<br>4 DC channels | 32 monopolar channels<br>8 bipolar channels<br>5 GND – 3 NE | 64 monopolar<br>4 DC channels | N/A | Similar. See Note<br>5. |
| CMRR | min>105 dB @ 16Hz<br>(>100 dB @ 50Hz) | > 100 dB | > 100 dB | N/A | Similar values. |
| Noise | <0.15 μVrms @ 128 Hz<br>(1.8 μVrms @ 32768<br>Hz) | <0.5μVrms | <0.3μVrms @ 256<br>Hz | N/A | Similar values.<br>See Note 6. |
| Input Impedance | Differential : 20 MΩ | Differential : 6.6 MΩ | Differential : 6.6<br>MΩ | N/A | |
| Low Pass Filter | 8KHz | 512Hz | 2KHz | N/A | Similar values. |
| High Pass Filter | DC | 0.1Hz | Selectable 0.1-<br>10Hz | N/A | See Note 7. |
| A/D Conversion | EEG channels: 24 bit<br>ΣΔ ADC<br>DC channels: 12 bit<br>SAR ADC | EEG channels: 24 bit<br>ΣΔ ADC | 16 bit SAR<br>effectively<br>transferred to host | N/A | Similar<br>technology with<br>improvements in<br>subject devices.<br>See Note 8. |
| Sampling Rate | Max sample frequency<br>32768Hz/channe | Max sample frequency<br>32768Hz/channe | Max sample<br>frequency<br>32768Hz/channe | N/A | All have more<br>than adequate<br>sampling rate for<br>EEG/PSG<br>measurements.<br>See Note 9. |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM<br>(K121996) | Galileo NT<br>(K142064) | |
| Trigger Mode | Internal and External…