(343 days)
The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients.
It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment.
The Neuronaute requires operation by a trained healthcare professional.
The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
The Neuronaute is a wearable and wireless equipment, which allows acquisition, recording, storage, transmission and displaying of electroencephalogram (EEG).
The Neuronaute is composed of a textile cap where twenty-one titanium dry electrodes are attached. An electronic box is attached to the cap (EEG recording) associated to batteries. The system operates on battery power only.
The system is connected to a device (i.e. smart phone or a digital tablet) loaded with a separate stand-alone software program ("app"). The app works with a cloud backend service, which allows the user management and authentication, the data storage for application recordings and access to this data via a web-based interface, the devices management and authentication, the recording scheduling, the download of the latest firmware version.
The acquired signals are saved in a universal data format (European Data Format, EDF) that is intended to be visualized by a Physician through the web-based interface.
Here's an analysis of the acceptance criteria and supporting study for the Neuronaute device, based on the provided FDA 510(k) summary:
The Neuronaute device is an electroencephalograph (EEG) system intended for acquiring, recording, storing, transmitting, and displaying EEG from adult patients. The acceptance criteria and supporting studies focus on demonstrating that the Neuronaute performs similarly to or better than predicate devices, and meets relevant electrical, software, and biocompatibility standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets and then "reported device performance" in a separate section. Instead, the "Performance Data" and "Technological Characteristics" sections describe testing conducted and the device's measured specifications, often compared directly to predicate devices to demonstrate substantial equivalence. I will synthesize the relevant information into a table, focusing on direct and inferable criteria for signal quality and electrical characteristics.
| Acceptance Criteria (Inferred from Predicate Equivalence & Standards) | Neuronaute Reported Performance |
|---|---|
| Electrical Performance: | |
| Sampling rate | 500 s/s (vs. predicate 256 s/s) |
| Dynamic range | +/- 600mV (vs. predicate +/- 1000 µV - note: units differ, but generally implies a range adequate for EEG) |
| Noise | < 6 µVpp (vs. predicate 3.7 µV typical - comparable or slightly higher, within acceptable range for EEG) |
| CMRR (Common Mode Rejection Ratio) | 115dB (vs. predicate 110dB - better) |
| Input Impedance | 1 Gohm (vs. predicate 100 Gohm - lower, but still high enough for good signal acquisition) |
| Hardware filtering | 125Hz lowpass (vs. predicate 100 Hz Low Pass) |
| Biocompatibility | Compliance with ISO 10993: Cytotoxicity, Irritation, Sensitization testing shown to be substantially equivalent to predicate. Materials (Ti6A14V ELI & OEKO-TEX® yarns) chosen for known biocompatibility. |
| Electromagnetic compatibility (EMC) & Electrical safety | Compliance with IEC 60601-2-26:2002 and FDA Guidance demonstrated, substantially equivalent to primary predicate. |
| Software Validation | Verification and validation according to IEC 62304:2006 and FDA Guidance "General Principles for Software Validation". Results demonstrated meeting requirements for safety, function, and intended use. |
| Signal Quality: | |
| Acceptability of signal quality against gold standard | Testing performed shows similar electrical and signal performance as the Rythmlink Disc Electrodes (K061148, considered gold standard). |
| Alpha Rhythm presence | Physiological tests showed normal presence of alpha modulation in eyes opening/closing task. |
| Impedance levels | Most impedances were below 1 MOhm. |
| Data loss | Chirp and Ramp tests presented no data lost with the current version of software. |
2. Sample Size Used for the Test Set and Data Provenance:
- Physiological Tests (Impedance, Alpha Rhythm):
- Impedance tests: 24 subjects.
- Alpha Rhythm tests: 26 healthy adult subjects.
- EEG signal testing for comparison with Rythmlink Disc Electrodes: The document doesn't explicitly state the number of subjects for this comparison, but it implies a test was conducted.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the mention of "healthy adult subjects," it implies a prospective clinical or research study was conducted internally or with a clinical partner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not describe the use of experts to establish ground truth for the physiological or comparative EEG signal quality tests. The "gold standard" comparison for EEG signal quality refers to a predicate device (Rythmlink Disc Electrodes), not expert interpretation of data. The physiological tests (Alpha Rhythm, Impedance) likely relied on objective measurements and established physiological markers rather than expert consensus for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no expert-based ground truth establishment or adjudication process is described for the tests mentioned. The assessment of signal quality and electrical performance appears to be based on direct measurement and comparison to predefined technical specifications and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The Neuronaute is described as a device that only acquires and displays physiological signals, with "no claims being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This means the device does not provide AI-assisted interpretations to be compared against human readers. Its function is data acquisition and display.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone algorithm performance study was not done, as the Neuronaute explicitly states it makes "no claims ... for analysis of the acquired signals." The "software" (firmware, mobile app, cloud) focuses on verification and validation of its functionality in acquiring, recording, storing, transmitting, and displaying data reliably and safely.
7. Type of Ground Truth Used:
- For EEG signal quality comparison: The "gold standard" was another cleared EEG electrode, Rythmlink Disc Electrodes (K061148). This serves as a technical ground truth for comparison of electrical and signal performance.
- For physiological tests (Alpha Rhythm, Impedance): The ground truth is based on established physiological phenomena (e.g., normal presence of alpha modulation, expected impedance levels) and objective measurements.
8. Sample Size for the Training Set:
The document does not mention any "training set" as it is not an AI/ML device that performs analysis or interpretation. The software validation is for the functionality of data handling and display, not for learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
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December 26, 2017
Bioserenity % Esin Yesilalan Senior Regulatory Scientist Voisin Consulting Inc. Life Sciences 222 Third Street Suite 3121 Cambridge, Massachusetts 02142
Re: K170138
Trade/Device Name: Neuronaute Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GXY Dated: June 20, 2017 Received: June 23, 2017
Dear Ms. Yesilalan.
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 (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. 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.
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2017.12.26 09:58:05 -05'00'
Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170138
Device Name Neuronaute
Indications for Use (Describe)
The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients.
It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment.
The Neuronaute requires operation by a trained healthcare professional.
The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
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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5. 510 (k) Summary
5.1 Submitter Information
| Company Name: | BioSerenity |
|---|---|
| Company Address: | 47 boulevard de l'Hôpital75013 Paris, France |
| Company Phone: | +33 157 274 456 |
| Company Fax: | +33 186 953 093 |
| Contact Person: | Mr. Quang TRAN |
| Date the summarywas prepared: | January 6, 2017 |
5.2 Device Identification
| Trade Name: Neuronaute | |
|---|---|
| Common Name: Neuronaute | |
| Classification Name: | Electroencephalograph |
| Product Code: | GWQ, GXY |
| Regulation Number: | 882.1400, 882.1320 |
| Device Class: II |
5.3 Identification of Predicate Devices
| Device Name | Primary Predicate | Additional Predicate |
|---|---|---|
| Manufacturer | Advanced Brain Monitoring | Rhythmlink International, LLC |
| 510(k) Number | K131383 | K061148 |
| Regulatory Class | II | II |
| Regulation Number | 882.1400 | 882.1320 |
| Product Code | GWQ, OMC | GXY |
| Common Name | X-10 / X-24 | Rhythmlink Disc electrodes |
| Clearance Date | November 27, 2013 | May 10, 2006 |
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Device Description 5.4
The Neuronaute is a wearable and wireless equipment, which allows acquisition, recording, storage, transmission and displaying of electroencephalogram (EEG).
The Neuronaute is composed of a textile cap where twenty-one titanium dry electrodes are attached. An electronic box is attached to the cap (EEG recording) associated to batteries. The system operates on battery power only.
The system is connected to a device (i.e. smart phone or a digital tablet) loaded with a separate stand-alone software program ("app"). The app works with a cloud backend service, which allows the user management and authentication, the data storage for application recordings and access to this data via a web-based interface, the devices management and authentication, the recording scheduling, the download of the latest firmware version.
The acquired signals are saved in a universal data format (European Data Format, EDF) that is intended to be visualized by a Physician through the web-based interface.
ર્સ્ડ Indications for Use
The Neuronaute is indicated for acquiring, recording, storing, transmitting, and displaying physiological data in adult patients. It can be used with patients in health care facility or clinical research environment. The Neuronaute requires operation by a trained healthcare professional. The Neuronaute acquires, records, stores, transmits, and displays electroencephalogram (EEG). The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
5.6 Comparison to Predicate Devices
The primary purpose of the Neuronaute is the recording of physiological signals, specifically EEG. In comparison with the Primary predicates, the Neuronaute does not contain ECG/EOG/EMG electrodes or accelerometer technology (for actigraphy). These additional features are not required for EEG recording; therefore, these differences do not affect the safety and effectiveness of the Neuronaute.
The Neuronaute has similar indications for use for EEG measurements and uses the same fundamental technology as the X-Series System for most features including the electrophysiological (EEG) and wireless acquisitions and actigraphy. Like the X-Series system, the Neuronaute acquires, records and transmits EEG signals. The technologies used in the Neuronaute are used in a similar manner as the X-Series System and do not raise new questions of safety and effectiveness.
5.7 Performance Data
Support for the substantial equivalence of the Neuronaute was provided as a result of risk management and testing which included electrical and biological safety, performance and software tests. Testing has provided reasonable assurance of safety and effectiveness for the intended use and supports a determination of substantial equivalence.
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The cleaning and disinfection procedures must be applied depending on the components. Procedures are provided in the User Manual.
Biocompatibility was assessed following ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The skin contact of the Neuronaute device is limited to 24 hours. Hence, per ISO 10993, Part 1, and the FDA-modified Matrix ("Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") the following tests are conducted to determine biocompatibility of Neuronaute: Cytotoxicity, Irritation. Sensitization. Neuronaute is not intended to be used on unhealthy skin and skin with open wounds. The yarns used in the Neuronaute and in contact with the skin were preferentially chosen according to OEKO-TEX® product Class I and Class II suitable for use in babies and textiles close to the skin such as underwear. The dry EEG electrodes are made of titanium alloy Ti6A14V (Ti-64) extra- low interstitial (ELI). Titanium and its alloys have a proven track record as biomedical implants due to their excellent biocompatibility.
The firmware in the Neuronaute, the mobile app and the Cloud have been tested through verification and validation according to the IEC 62304:2006 standard and as per the FDA Guidance "General Principles for Software Validation". The results of the verification and validation activities demonstrate that the software meet the requirements for safety, function and intended use.
Electromagnetic compatibility and electrical safety testing of the Neuronaute was conducted following recognized standards for electro-medical equipment. Compliance to the specific IEC 60601-2-26:2002 - "Particular - requirements - for for - the - safety standards or electroencephalographs" regarding the operational and mechanical performance has been demonstrated.
The reusable EEG dry electrodes used with the Neuronaute have been tested to demonstrate their electrical and signal acquisition performance. While the scope of the standards does not cover EEG electrodes testing using applicable methods defined in chapter 4 of AAMI/ANSI EC12:2000 (R)2010 Disposable ECG electrodes has been conducted, as well as for another cleared EEG electrode, Rythmlink Disc Electrodes (K061148). Testing performed show that the dry titanium EEG electrodes has similar electrical performance as the Rythmlink Disc Electrodes (K061148).
EEG signals testing has been performed on the Neuronaute in comparison with the gold standard, assimilated to another cleared EEG electrode, Rythmlink Disc Electrodes (K061148) to demonstrate the acceptability of the signals quality. Testing performed show that the dry titanium EEG electrodes has similar signal performance as the Rythmlink Disc Electrodes (K061148).
EEG signals testing has been performed on the Neuronaute to demonstrate the acceptability of the signals quality. The Impedance tests were performed on a cohort of 24 subjects. The Alpha Rhythm tests were performed on a cohort of 26 healthy adult subjects. The Chirp and Ramp tests demonstrate an acceptable lag between the box and presented no data lost with the current version of software. The physiological tests showed a normal presence of alpha modulation in the eyes opening/closing task. Most impedances were below 1MOhms. Altogether, the latest hardware and software versions of the Neuronaute show acceptable results for a release.
Finally, as part of the Design Control, other testing has been performed to ensure that the specifications defined have been met.
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| 5.8 | Technological Characteristics | ||
|---|---|---|---|
| Specification | Neuronaute(Bioserenity) | Primary PredicateX-series System(Advanced BrainMonitoring) | Additional PredicateRythmlink DiscElectrodes(RhythmlinkInternational, LLC) |
| 510(k) number | Current Submission(K170138) | K131383 | K061148 |
| Clinical characteristics | |||
| Indications foruse | The Neunoraute is amedical, wireless andmobile equipment,which allowsacquisition, record,storage, transmissionand displaying ofelectroencephalogram(EEG) from adultpatients. It can be usedwith patients in healthcare facility (dataacquisition andreporting) or clinicalresearch environment.The Neuronauterequires operation by atrained healthcareprofessional. TheNeuronaute onlyacquires and displaysphysiological signals,no claims are beingmade for analysis of theacquired signals withrespect to the accuracy,precision and reliability. | The X-Series System isintended for prescription usein the home, healthcarefacility, or clinical researchenvironment to acquire,transmit, display and storephysiological signals frompatients ages 6 and older.The X-Series systemrequires operation by atrained technician. The X-Series System acquires,transmits, displays andstoreselectroencephalogram(EEG), electrooculogramn(EOG), electrocardiogram(ECG),and/or electromyogram(EMG), and accelerometersignals. The X-SeriesSystem only acquires anddisplays physiologicalsignals, no claims are beingmade for analysis of theacquired signals with respectto the accuracy, precisionand reliability. | The Rythmlink DiscElectrodes are intendedfor non-invasive usewith recording andmonitoring equipment,(active and reference),of Electromyography(EMG),Electroencephalography(EEG) and EvokedPotentials. |
| Intended use | Acquire, display, store and archiveelectroencephalograph signals from the brain using afull montage array (i.e, 16 or more electrodes) and userspecified locations. | Acquisition of signalsfor the purpose ofmonitoring andrecording of EEG,EMG and Evokedpotentials (EP) | |
| Class | II | ||
| Product Code | GWQ, GXY | GWQ, OMC | GXY |
| CFR Section | 882.1400 | 882.1320 | |
| Device Panel | Neurology | ||
| Patientpopulation | Adults | Ages 6 and older | Not found |
| User | Trained Healthcareprofessional | Trained Technician | Healthcare professional/ technicians |
| Specification | Neuronaute(Bioserenity) | Primary PredicateX-series System(Advanced BrainMonitoring) | Additional PredicateRythmlink DiscElectrodes(RhythmlinkInternational, LLC) |
| Anatomical sites | Forehead, Scalp | Scalp and Chest | Head and body |
| Environment ofUse | Healthcare facility (dataacquisition andreporting)Clinical ResearchEnvironment | Home (data acquisition)Healthcare facility (dataacquisition, analysis andreporting)Clinical ResearchEnvironment | Healthcare facilityClinical ResearchEnvironment |
| User Interface | Usual control, visual indicators | N/A | N/A |
| Technological characteristics | |||
| EEG | |||
| EEG electrodes | 21 reusable dry titaniumelectrodes plus 2referential channelsusing Ag/AgCl discelectrodes | Up to 20 differential orreferential channels | Ag/Ag Cl discelectrodes |
| Contact electrodetype | Dry electrode | Wet electrode composed bya metal film part, anadhesive foam and EEGpaste. | Wet electrode (to beused with EEG paste) |
| Shape | Comb-like electrodes(hair design)Conical electrodes(frontal design) | Metal film part. Cylindricaladhesive foam. | Disc electrode |
| Method of use | Reusable | Reusable metal film part.Disposable adhesive foamand synapse cream. | Disposable |
| Raw material | Titanium | Ag/AgCl | Ag/AgCl |
| Signal processingtechniques (e.g.filtering, etc.) | Sampling rate: 500 s/sNo Highpass appliedon raw data.Hardware filtering:125Hz lowpass Variousfilters are applicable inthe viewer software | Sampling rate: 256 s/s0.1 Hz High Pass100 HzLow Pass, hardware | N/A |
| Accuracy.variance anderror ofmeasurements | Sampling rate: 500 s/sDynamic range: =+/-600mVNoise : $ < 6\mu $ Vpp | Sampling rate: 256 s/sDynamic range: =+/-1000 $\mu$ VNoise: 3.7 $\mu$ V (typical) | N/A |
| ECG | Not available | Dual lead ECG | N/A |
| EOG/EMGElectrodes | Not available | Up to 4 optional singlechannels either dual leadelectrooculogram (EOG) orelectromyogram (EMG) | N/A |
| Specification | Neuronaute(Bioserenity) | Primary PredicateX-series System(Advanced BrainMonitoring) | Additional PredicateRythmlink DiscElectrodes(RhythmlinkInternational, LLC) |
| Linked MastoidSensors | Disposable Ag/Cl sensors with adhesive | N/A | |
| SignalsAcquired | • Forehead/head 21EEG channels | • Up to 20 EEG scalpchannels• 3-D actigraphy• 4 optional single channeleither dual lead EOG orEMG• Single optional ECGchannel | • EEG, EMG signals• EP |
| CMRR | 115dB | 110dB | N/A |
| InputImpedance | 1Gohm | 100Gohm | N/A |
| Power Supply | 2 x 2300mAH 3.7V Li-Ion batteries | 2 to 4 X 240mAH 3.7 Li-Ionbatteries | N/A |
| BatteryCharging | Operators - externalbattery pack | Via JED Connectorconnected to USB port orUSB wall charger | N/A |
| TypicalCharging Time | 0.5-3.0 hours dependingof discharge depth | 0.5-5.0 hours | NA |
| Acquisitionmodes | Record | Monitor only | N/A |
| Operating Time | 4.0 hours | Monitoring Days afterCharge Hours of Use• 0-4 Days: 16 to 17hours• 5-10 Days: 14 to 15hours | N/A |
| Data storage | Streaming data | Not used. The X-Seriessystem does not include arecord mode where data isstored on the recorder | N/A |
| File size per 8hours recording | 1000MB (edf files)1000MB (video) | 512 MB | N/A |
| Dimensions | Different sizes of capsare available | 5.0" long, 2.25" widen 1.0'deep | 10mm diameterCable length: 150cm |
| Weight | Electronic boxes: 2ouncesBattery pack: 2.68ounces | 3.9 ounces with twobatteries | < 1 ounce |
| Specification | Neuronaute(Bioserenity) | Primary PredicateX-series System(Advanced BrainMonitoring) | Additional PredicateRythmlink DiscElectrodes(RhythmlinkInternational, LLC) |
| Cleaning | For EEG electrodes: thechlorhexidine baseddisinfection processsupported by hospitalservicesFor clothes: any softneutral pH detergent | Cleaned and disinfected byrubbing with isopropylalcohol | Cleaned with water andsoft detergent.Disinfection withcommon useddisinfectant at hospitaldiluted at 2% |
| Data transferfrom SD card | Not applicable | USB Dongle | N/A |
| Wireless datatransfer | Bluetooth and Wifi | Bluetooth 2.0 | N/A |
| MaximumBluetoothwireless transferdistance andrate | Transfer distance 10meters line of sight,maximum transfer notspecified | Transfer distance 10 metersline of sight, maximumtransfer rate 3 Mbaud | N/A |
| Compatibility | For the mobile app:iOS 9 and higheriPhone® 6, 6 plus, 6S,6S plusiPad air, iPad air 2, iPadProFor the Cloud(Bioserenity.force.com):any web navigators | Windows 8, 7, and XP, PCwith 2.0 GHz or higherprocessor & 1 GB of RAM | N/A |
| Estimate filesize per minute | 2000 KB/min | 45 KB/Min | N/A |
| File format type | European data format (EDF) | N/A | |
| Software | Software presents waveforms | N/A | |
| Biological characteristics | |||
| Category ofdevice | Surface Device | ||
| Type of contact | Intact skin | ||
| Contactduration | Limited | N/A | |
| Non-Clinical Testing | |||
| Biocompatibility | Testing in compliance with FDA Guidance "Use of International StandardISO10993, Biological Evaluation of Medical Devices Part 1: Evaluation andTesting was performed and demonstrated substantially equivalent performance toidentified predicate devices. The following non-clinical tests have been performed:Cytotoxicity, Sensitization and Irritation. | ||
| Specification | Neuronaute(Bioserenity) | Primary PredicateX-series System(Advanced BrainMonitoring) | Additional PredicateRythmlink DiscElectrodes(RhythmlinkInternational, LLC) |
| Electromagneticcompatibilityand electricalsafety | Testing in compliance with FDA Guidance “Information to support a claim ofelectromagnetic compatibility (EMC) of electrically-powered medical devices wasperformed and demonstrated substantially equivalent to primary predicate device. |
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§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).