Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard EEG/PSG signal acquisition and processing without mentioning any AI/ML algorithms for analysis or interpretation.

Therapeutic

No.
The device is used for diagnosis and monitoring, not for direct treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is intended "to assist the user in diagnosis and monitoring of disorders." The device acquires bioelectric signals, which are then processed by software for "visualization, measurement, processing and storage of brain signals," all of which are steps involved in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the EEG Family devices (BE plus PRO and Neurotravel LIGHT) are "active medical devices composed of various parts necessary to allow the achievement of their intended use" and are capable of acquiring bioelectric signals using electrodes, filtering, digitizing, and transferring them to a Host PC. This indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the devices are used for Electroencephalography (EEG) and Polysomnography (PSG) exams. These are procedures that measure electrical activity in the brain and other physiological signals from the body.
Device Description: The description details the acquisition of bioelectric signals generated by the electrical potentials of neurons. This involves direct interaction with the patient's body (via electrodes) to measure physiological signals.
IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens, including blood, urine, and tissue, from the human body to provide information for diagnosis, monitoring, or screening purposes. They perform tests outside of the living body.

The BE Plus PRO and Neurotravel LIGHT devices are used to acquire physiological signals from the living body, not to test specimens from the body. Therefore, they fall under the category of medical devices used for physiological monitoring and diagnosis, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

GWL, GWQ, OLT, OLV

Device Description

EEG Family devices (BE plus PRO and Neurotravel LIGHT) are active medical devices composed of various parts necessary to allow the achievement of their intended use. All these parts are intended to be interconnected to achieve the specified medical purpose.

EEG Family devices can be used in patient homes, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.

EEG Family devices are capable of acquiring the bioelectric signal generated by the electrical potentials of the neurons of the cerebral cortex, by means of suitable signal, citius electrodes. This signal, of the order of a first and them, filtered to claim it of noise and offset. It is then digitized by a high-resolution analog-to-digital converter at a certain sampling rate.

The signals acquired and converted into digital format are transferred to a Host PC through a special serial communication with a dedicated protocol and then can be processed by the Galileo NT software to complete the intended use.

The software part allows the implementation of many specific functions of visualization, measurement, processing and storage of brain signals, acquired by the acquisition unit, based on the clinical area of interest.

EEG 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Central and peripheral nervous system and muscles.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended Usage Site: Medical facilities with environment and electric network compatible with EEG usage standards.
Intended User: Neurology physicians, Neurophysiopathology technicians under physician's supervision, other physicians such as anesthesiologists, neonatologists and nursing staff of intensive care unit.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Test Summary and Conclusion
Due to the enhancements made to the electrical components, it was necessary to verify the electrical/mechanical/thermal safety and electromagnetic compatibility (EMC) of the subject devices. This was performed using the exact same test methods used for the predicate device using FDA-recognized external standards ANSI/AAMI ES60601-1 and IEC 60601-1-2.
The subject devices passed all requirements of these standards. No deviations or exceptions were encountered.
Conclusion
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121996, K142064

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

September 4, 2024

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a symbol of three faces in profile, arranged in a circular pattern.

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).

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

2

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

3

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)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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4

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	marco.rossi@ebneuro.com
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	bashar@makromed.com

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

5

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)

6

Item	Subject Devices		Predicate Devices
	BE Plus PRO	Neurotravel LIGHT	BE Plus LTM
(K121996)	Galileo NT
(K142064)
Intended Use
Intended Use	Medical Device
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 disorder
of the central and
peripheral nervous
system and muscles.	Medical Device
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 disorder
of the central and
peripheral nervous
system and muscles.	Acquisition of
EEG, polygraphy
and
polysomnography
signals and
transmission of
these to a PC
during recording of
neurophysiology
examinations.	Intended to
record and
display EEG,
Video-EEG,
LTM, PSG,
EMG, EP data
acquired from the
patient body
through EB
Neuro acquisition
platform, to aid
the diagnosis and
monitoring of
potential
disorders of the
central and
peripheral
nervous system
and muscles.	Similar. See Note

| Intended Usage
Site | Medical facilities with
environment and
electric network
compatible with EEG
usage standards. | Medical facilities with
environment and
electric network
compatible with EEG
usage standards. | Medical facilities
with environment
and electric
network
compatible with
EEG usage
standards. | The device is
intended to
be used in the
clinical and
hospital
environment
(including the
hospital | Same |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM
(K121996) | Galileo NT
(K142064) | |
| | | | | room, emergency
room, intensive
care unit, neuro-
intensive care
unit, critical care
unit). | |
| Intended User | Neurology physicians,
Neurophysiopathology
technicians under
physician's supervision,
other physicians such as
anesthesiologists,
neonatologists and
nursing staff of intensive
care unit. | Neurology physicians,
Neurophysiopathology
technicians under
physician's supervision,
other physicians such as
anesthesiologists,
neonatologists and
nursing staff of intensive
care unit. | The “BE Plus
LTM / GWI”
amplifier system is
intended to be used
by or under
direction of a
physician for
acquisition of
EEG, polygraphy
and
polysomnography
signals and
transmission of
these signals to a
host PC during
recording of
neurophysiology
examinations. | This device is
intended to
be used by
qualified
medical
practitioners who
will exercise
professional
judgment in using
the information. | Same |
| Design - General | | | | | |
| System
Configuration | It is a signal acquisition
device connected to a PC
with Galileo NT software
running on the PC. It can
be placed on a trolley | It is a signal acquisition
device connected to a PC
with Galileo NT software
running on the PC. It can
be placed on a trolley | It is a signal
acquisition device
intended to be
connected to a PC
with Galileo NT | It is a software
only device,
deployed on a
Windows-based
PC. | Similar. See Note
2. |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM
(K121996) | Galileo NT
(K142064) | |
| | (mobile version) or on a
desk (portable version). | (mobile version) or on a
desk (portable version). | software running on
the PC. The PC can
be placed on a
trolley (mobile
version) or on a desk
(portable version). | | |
| Power Supply | 115 V medical power
supply and internal
battery. | 115 V medical power
supply. | 115 V medical
power supply and
internal battery. | N/A | Same |
| PC Connection | USB, Ethernet, Wi-Fi. | USB | USB, Ethernet, Wi-
Fi. | N/A | Same |
| Components and
Accessories | Flash LED stimulator
Pulse Oximeter module
Windows PC
Keyboard, mouse,
printer
Trolley
Batteries
Cables | Flash LED stimulator
Pulse Oximeter module
Windows PC
Keyboard, mouse,
printer
Trolley
Batteries
Cables | Flash LED
stimulator
Pulse Oximeter
module
Batteries
Cables | Software
intended to be
deployed on a PC
equipped with
keyboard, mouse,
printer, and
mounted on a
desktop or
trolley. | Similar. See Note
3. |
| Computer | - Desktop PC

Panel PC
Laptop PC | - Desktop PC
Panel PC
Laptop PC | Intended for:
Desktop PC
Panel PC
Laptop PC | Intended for:
Desktop PC
Panel PC
Laptop PC | Same |
| Operating
System | Windows | Windows | Windows | Windows | Same |
| Software | Resident and runtime
downloadable. | Resident and runtime
downloadable. | Resident and
runtime
downloadable. | Resident and
runtime
downloadable. | Same |
| Item | Subject Devices | | Predicate Devices | | Comments |
| | BE Plus PRO | Neurotravel LIGHT | BE Plus LTM
(K121996) | Galileo NT
(K142064) | |
| Ports | 2 DC Link
1 USB Link
2 DC Out/Aux I/O | 1 USB Link
1 DC-AUX I/O | 2 DC Link
2 DC Out/Aux I/O | N/A | Similar. See Note