(30 days)
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.
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 patients, 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, stimulus electrodes. This signal, of the order of a first and then, 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.
The provided text describes specific details about device performance relative to established standards. However, it does not contain information about a study designed to evaluate acceptance criteria in the context of diagnostic accuracy, human reader performance, or clinical outcomes. The "acceptance criteria" presented are primarily related to safety and electromagnetic compatibility standards, rather than performance metrics like sensitivity, specificity, or reader agreement.
Based on the provided text, here's an analysis:
Acceptance Criteria and Device Performance (Safety and EMC)
| Acceptance Criteria Category | Standard Applied | Reported Device Performance |
|---|---|---|
| Electrical, Mechanical, and Thermal Safety | ANSI/AAMI ES60601-1, IEC 60601-2-26 (for BE Plus PRO) | "The subject devices passed all requirements of these standards. No deviations or exceptions were encountered." |
| Electromagnetic Compatibility | IEC 60601-1-2 | "The subject devices passed all requirements of these standards. No deviations or exceptions were encountered." |
| Medical Device Software | IEC 62304 | "Same" as predicate devices (implies compliance) |
| Medical Device Risk Management | ISO 14971 | "Same" as predicate devices (implies compliance) |
Missing Information (Not Available in Provided Text):
The provided text focuses on demonstrating substantial equivalence based on safety and performance standards for an amplifier and software, not on evaluating a diagnostic algorithm's accuracy against a ground truth or its impact on human reader performance. Therefore, the following requested information is not present in the given document:
- Sample size used for the test set and the data provenance: Not applicable to the type of testing described (safety and EMC).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physiological signal amplifier and analysis software, not an AI-based diagnostic aid that directly improves human reader performance in a comparative study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software" component seems to be for signal processing, visualization, and measurement, not a diagnostic algorithm that would have standalone performance metrics like sensitivity/specificity.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to safety and EMC testing.
- The sample size for the training set: Not applicable. These are hardware (amplifier) and signal processing software, which typically don't have "training sets" in the AI/machine learning sense.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study Performed:
The study performed was a non-clinical performance evaluation focusing on the physical and operational aspects of the BE Plus PRO and Neurotravel LIGHT devices (physiological signal amplifiers and associated software).
- Objective: To verify the electrical/mechanical/thermal safety and electromagnetic compatibility (EMC) of the subject devices, particularly due to enhancements made to electrical components compared to their predicate devices.
- Methodology: The evaluation was conducted using the exact same test methods as those used for the predicate devices, adhering to FDA-recognized external standards:
- ANSI/AAMI ES60601-1 (Electrical, Mechanical, and Thermal Safety)
- IEC 60601-2-26 (Specific to EEG equipment, for BE Plus PRO)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 62304 (Medical Device Software)
- ISO 14971 (Medical Device Risk Management)
- Results: The subject devices "passed all requirements of these standards. No deviations or exceptions were encountered."
- Conclusion: The manufacturer concluded that 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."
This type of study is typical for demonstrating substantial equivalence for hardware devices and their accompanying software in terms of safety and basic functionality, rather than complex diagnostic AI performance.
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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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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 | 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 |
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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(K121996) | Galileo NT(K142064) | ||
| Intended Use | |||||
| Intended Use | Medical Deviceintended to be used forElectroencephalography(EEG), andPolysomnography(PSG) exams, incombination with theGalileo NT Linesoftware, for humanbeings to assist the userin diagnosis andmonitoring of disorderof the central andperipheral nervoussystem and muscles. | Medical Deviceintended to be used forElectroencephalography(EEG), andPolysomnography(PSG) exams, incombination with theGalileo NT Linesoftware, for humanbeings to assist the userin diagnosis andmonitoring of disorderof the central andperipheral nervoussystem and muscles. | Acquisition ofEEG, polygraphyandpolysomnographysignals andtransmission ofthese to a PCduring recording ofneurophysiologyexaminations. | 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. |
| Intended UsageSite | Medical facilities withenvironment andelectric networkcompatible with EEGusage standards. | Medical facilities withenvironment andelectric networkcompatible with EEGusage standards. | Medical facilitieswith environmentand electricnetworkcompatible withEEG usagestandards. | The device isintended tobe used in theclinical andhospitalenvironment(including thehospital | Same |
| Item | Subject Devices | Predicate Devices | Comments | ||
| BE Plus PRO | Neurotravel LIGHT | BE Plus LTM(K121996) | Galileo NT(K142064) | ||
| room, emergencyroom, intensivecare unit, neuro-intensive careunit, critical careunit). | |||||
| 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 “BE PlusLTM / GWI”amplifier system isintended to be usedby or underdirection of aphysician foracquisition ofEEG, polygraphyandpolysomnographysignals andtransmission ofthese signals to ahost PC duringrecording ofneurophysiologyexaminations. | This device isintended tobe used byqualifiedmedicalpractitioners whowill exerciseprofessionaljudgment in usingthe information. | Same |
| Design - General | |||||
| SystemConfiguration | It is a signal acquisitiondevice connected to a PCwith Galileo NT softwarerunning on the PC. It canbe placed on a trolley | It is a signal acquisitiondevice connected to a PCwith Galileo NT softwarerunning on the PC. It canbe placed on a trolley | It is a signalacquisition deviceintended to beconnected to a PCwith Galileo NT | It is a softwareonly device,deployed on aWindows-basedPC. | Similar. See Note2. |
| Item | Subject Devices | Predicate Devices | Comments | ||
| BE Plus PRO | Neurotravel LIGHT | BE Plus LTM(K121996) | Galileo NT(K142064) | ||
| (mobile version) or on adesk (portable version). | (mobile version) or on adesk (portable version). | software running onthe PC. The PC canbe placed on atrolley (mobileversion) or on a desk(portable version). | |||
| Power Supply | 115 V medical powersupply and internalbattery. | 115 V medical powersupply. | 115 V medicalpower supply andinternal battery. | N/A | Same |
| PC Connection | USB, Ethernet, Wi-Fi. | USB | USB, Ethernet, Wi-Fi. | N/A | Same |
| Components andAccessories | Flash LED stimulatorPulse Oximeter moduleWindows PCKeyboard, mouse,printerTrolleyBatteriesCables | Flash LED stimulatorPulse Oximeter moduleWindows PCKeyboard, mouse,printerTrolleyBatteriesCables | Flash LEDstimulatorPulse OximetermoduleBatteriesCables | Softwareintended to bedeployed on a PCequipped withkeyboard, mouse,printer, andmounted on adesktop ortrolley. | Similar. See Note3. |
| 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 |
| OperatingSystem | Windows | Windows | Windows | Windows | Same |
| Software | Resident and runtimedownloadable. | Resident and runtimedownloadable. | Resident andruntimedownloadable. | Resident andruntimedownloadable. | Same |
| Item | Subject Devices | Predicate Devices | Comments | ||
| BE Plus PRO | Neurotravel LIGHT | BE Plus LTM(K121996) | Galileo NT(K142064) | ||
| Ports | 2 DC Link1 USB Link2 DC Out/Aux I/O | 1 USB Link1 DC-AUX I/O | 2 DC Link2 DC Out/Aux I/O | N/A | Similar. See Note4. |
| Signal | Analog to digitalacquisition at variablesampling rate | Analog to digitalacquisition at variablesampling rate | Analog to digitalacquisition atvariable samplingrate | N/A | Same |
| Trigger Input(synchronizationto externalsignal) | TTL LEVEL | TTL LEVEL | TTL LEVEL | N/A | Same |
| Trigger Output(synchronizationfor externalsignal) | Flash LED Stimulatoris triggered by GalileoNT Line softwarerunning on host PC. | Flash LED Stimulatoris triggered by GalileoNT Line softwarerunning on host PC. | Flash LEDStimulator istriggered byGalileo NT Linesoftware runningon host PC. | N/A | Same |
| Patient CircuitryIsolation | Patient isolation BFtype | Patient isolation BFtype | Patient isolationBF type | N/A | Same |
| DeviceDimensions | 120 (L) x 210 (W) x 48(H) (mm) | 120 (L) x 174 (W) x 31(H) (mm) | 170 (L) x 110 (W)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 | |||||
| MeasurementPrinciple | The device providesacquisition of thephysiological signalthat is subsequentlyelaborated on thesoftware on Host PC. | The device providesacquisition of thephysiological signalthat is subsequentlyelaborated on thesoftware on Host PC. | The deviceprovidesacquisition of thephysiologicalsignal that issubsequently | N/A | Same |
| Item | Subject Devices | Predicate Devices | Comments | ||
| BE Plus PRO | Neurotravel LIGHT | BE Plus LTM(K121996) | Galileo NT(K142064) | ||
| elaborated on thesoftware on HostPC. | |||||
| Number ofChannels | 22-34 monopolarchannels4-12 bipolar channels4 DC channels | 32 monopolar channels8 bipolar channels5 GND – 3 NE | 64 monopolar4 DC channels | N/A | Similar. See Note5. |
| CMRR | min>105 dB @ 16Hz(>100 dB @ 50Hz) | > 100 dB | > 100 dB | N/A | Similar values. |
| Noise | <0.15 μVrms @ 128 Hz(1.8 μVrms @ 32768Hz) | <0.5μVrms | <0.3μVrms @ 256Hz | N/A | Similar values.See Note 6. |
| Input Impedance | Differential : 20 MΩ | Differential : 6.6 MΩ | Differential : 6.6MΩ | N/A | |
| Low Pass Filter | 8KHz | 512Hz | 2KHz | N/A | Similar values. |
| High Pass Filter | DC | 0.1Hz | Selectable 0.1-10Hz | N/A | See Note 7. |
| A/D Conversion | EEG channels: 24 bitΣΔ ADCDC channels: 12 bitSAR ADC | EEG channels: 24 bitΣΔ ADC | 16 bit SAReffectivelytransferred to host | N/A | Similartechnology withimprovements insubject devices.See Note 8. |
| Sampling Rate | Max sample frequency32768Hz/channe | Max sample frequency32768Hz/channe | Max samplefrequency32768Hz/channe | N/A | All have morethan adequatesampling rate forEEG/PSGmeasurements.See Note 9. |
| Item | Subject Devices | Predicate Devices | Comments | ||
| BE Plus PRO | Neurotravel LIGHT | BE Plus LTM(K121996) | Galileo NT(K142064) | ||
| Trigger Mode | Internal and External | Internal and External | Internal and External | N/A | Same |
| Ohmmeter | Measurement of the impedance in all bioelectric channels in the range 1-100 KOhm with precision of +/- 10% | Measurement of the impedance in all bioelectric channels in the range 1-100 KOhm with precision of +/- 10% | Measurement of the impedance in all bioelectric channels in the range 1-100 KOhm with precision of +/- 10% | N/A | Same |
| Performance Standards | |||||
| Electrical, Mechanical and Thermal Safety | ANSI AAMI 60601-1IEC 60601-2-26 | ANSI AAMI 60601-1 | ANSI AAMI 60601-1 | N/A | Same |
| Electromagnetic Compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Same |
| Medical Device Software | IEC 62304 | IEC 62304 | IEC 62304 | IEC 62304 | Same |
| Medical Device Risk Management | ISO 14971 | ISO 14971 | ISO 14971 | ISO 14971 | Same |
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EB Neuro S.p.A., Special 510(k) EEG Family Devices
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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.
Note 2: The subject devices are essentially a bundled package of the two predicate devices. As a result, their system configuration is a combination of the system configuration of the predicate devices.
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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: USB ports were not common on PCs when the predicate device BE Plus LTM was commercialized. USB ports are commonly used today and do not raise any additional questions of safety or effectiveness.
Note 5: 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 6: BE PLUS PRO offers better signal quality and lower noise with a more precise EEG measurement.
Note 7: Neurotravel LIGHT is limited to the EEG routine only, while BE PLUS LTM are set to a wider frequency band to also satisfy other applications (for example EP exams) for markets in countries other than the U.S.
Note 8: Sigma-Deltas (ΣΔ) have high resolution and are power efficient.
Note 9: Majority of brain wave activities fall below 512 Hz. The subject and predicate devices have sufficiently high sampling rates to capture these signals adequately. BE Plus PRO's exceptionally high sampling rate makes it more useful for advanced research studies.
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Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
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 defices All identified differences between the two systems are minor and without any known impact on safety or efficacy.
§ 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).