NEURONAUTE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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); {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------| | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Bioserenity. The logo features a light blue globe with interconnected lines, suggesting a network or global connection. Below the globe, the word "BIOSERENITY" is written in a bold, sans-serif font, also in light blue. ### 5. 510 (k) Summary #### 5.1 Submitter Information | Company Name: | BioSerenity | |-----------------------------------|--------------------------------------------------| | Company Address: | 47 boulevard de l'Hôpital<br>75013 Paris, France | | Company Phone: | +33 157 274 456 | | Company Fax: | +33 186 953 093 | | Contact Person: | Mr. Quang TRAN | | Date the summary<br>was 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 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Bioserenity. The logo features a stylized globe with interconnected lines, rendered in a light blue color. Below the globe, the word "BIOSERENITY" is written in a bold, sans-serif font, also in the same light blue color. #### 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for BIOSERENITY. The logo features a stylized globe with interconnected lines, suggesting a network or global connection. The company name, "BIOSERENITY," is written in a sans-serif font below the globe. 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for BIOSERENITY. The logo features a blue globe-like design with interconnected lines, suggesting a network or global connection. Below the graphic is the company name, "BIOSERENITY," in a bold, sans-serif font, also in blue. | 5.8 | Technological Characteristics | | | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Specification | Neuronaute<br>(Bioserenity) | Primary Predicate<br>X-series System<br>(Advanced Brain<br>Monitoring) | Additional Predicate<br>Rythmlink Disc<br>Electrodes<br>(Rhythmlink<br>International, LLC) | | 510(k) number | Current Submission<br>(K170138) | K131383 | K061148 | | Clinical characteristics | | | | | Indications for<br>use | The Neunoraute is a<br>medical, wireless and<br>mobile equipment,<br>which allows<br>acquisition, record,<br>storage, transmission<br>and displaying of<br>electroencephalogram<br>(EEG) from adult<br>patients. It can be used<br>with patients in health<br>care facility (data<br>acquisition and<br>reporting) or clinical<br>research environment.<br>The Neuronaute<br>requires operation by a<br>trained healthcare<br>professional. The<br>Neuronaute only<br>acquires and displays<br>physiological signals,<br>no claims are being<br>made for analysis of the<br>acquired signals with<br>respect to the accuracy,<br>precision and reliability. | The X-Series System is<br>intended for prescription use<br>in the home, healthcare<br>facility, or clinical research<br>environment to acquire,<br>transmit, display and store<br>physiological signals from<br>patients ages 6 and older.<br>The X-Series system<br>requires operation by a<br>trained technician. The X-<br>Series System acquires,<br>transmits, displays and<br>stores<br>electroencephalogram<br>(EEG), electrooculogramn<br>(EOG), electrocardiogram<br>(ECG),<br>and/or electromyogram<br>(EMG), and accelerometer<br>signals. The X-Series<br>System only acquires and<br>displays physiological<br>signals, no claims are being<br>made for analysis of the<br>acquired signals with respect<br>to the accuracy, precision<br>and reliability. | The Rythmlink Disc<br>Electrodes are intended<br>for non-invasive use<br>with recording and<br>monitoring equipment,<br>(active and reference),<br>of Electromyography<br>(EMG),<br>Electroencephalography<br>(EEG) and Evoked<br>Potentials. | | Intended use | Acquire, display, store and archive<br>electroencephalograph signals from the brain using a<br>full montage array (i.e, 16 or more electrodes) and user<br>specified locations. | | Acquisition of signals<br>for the purpose of<br>monitoring and<br>recording of EEG,<br>EMG and Evoked<br>potentials (EP) | | Class | II | | | | Product Code | GWQ, GXY | GWQ, OMC | GXY | | CFR Section | 882.1400 | | 882.1320 | | Device Panel | Neurology | | | | Patient<br>population | Adults | Ages 6 and older | Not found | | User | Trained Healthcare<br>professional | Trained Technician | Healthcare professional<br>/ technicians | | Specification | Neuronaute<br>(Bioserenity) | Primary Predicate<br>X-series System<br>(Advanced Brain<br>Monitoring) | Additional Predicate<br>Rythmlink Disc<br>Electrodes<br>(Rhythmlink<br>International, LLC) | | Anatomical sites | Forehead, Scalp | Scalp and Chest | Head and body | | Environment of<br>Use | Healthcare facility (data<br>acquisition and<br>reporting)<br>Clinical Research<br>Environment | Home (data acquisition)<br>Healthcare facility (data<br>acquisition, analysis and<br>reporting)<br>Clinical Research<br>Environment | Healthcare facility<br>Clinical Research<br>Environment | | User Interface | Usual control, visual indicators | N/A | N/A | | Technological characteristics | | | | | EEG | | | | | EEG electrodes | 21 reusable dry titanium<br>electrodes plus 2<br>referential channels<br>using Ag/AgCl disc<br>electrodes | Up to 20 differential or<br>referential channels | Ag/Ag Cl disc<br>electrodes | | Contact electrode<br>type | Dry electrode | Wet electrode composed by<br>a metal film part, an<br>adhesive foam and EEG<br>paste. | Wet electrode (to be<br>used with EEG paste) | | Shape | Comb-like electrodes<br>(hair design)<br>Conical electrodes<br>(frontal design) | Metal film part. Cylindrical<br>adhesive foam. | Disc electrode | | Method of use | Reusable | Reusable metal film part.<br>Disposable adhesive foam<br>and synapse cream. | Disposable | | Raw material | Titanium | Ag/AgCl | Ag/AgCl | | Signal processing<br>techniques (e.g.<br>filtering, etc.) | Sampling rate: 500 s/s<br>No Highpass applied<br>on raw data.<br>Hardware filtering:<br>125Hz lowpass Various<br>filters are applicable in<br>the viewer software | Sampling rate: 256 s/s<br>0.1 Hz High Pass100 Hz<br>Low Pass, hardware | N/A | | Accuracy.<br>variance and<br>error of<br>measurements | Sampling rate: 500 s/s<br>Dynamic range: =+/-<br>600mV<br>Noise : $ < 6\mu $ Vpp | Sampling rate: 256 s/s<br>Dynamic range: =+/-<br>1000 $\mu$ V<br>Noise: 3.7 $\mu$ V (typical) | N/A | | ECG | Not available | Dual lead ECG | N/A | | EOG/EMG<br>Electrodes | Not available | Up to 4 optional single<br>channels either dual lead<br>electrooculogram (EOG) or<br>electromyogram (EMG) | N/A | | Specification | Neuronaute<br>(Bioserenity) | Primary Predicate<br>X-series System<br>(Advanced Brain<br>Monitoring) | Additional Predicate<br>Rythmlink Disc<br>Electrodes<br>(Rhythmlink<br>International, LLC) | | Linked Mastoid<br>Sensors | Disposable Ag/Cl sensors with adhesive | | N/A | | Signals<br>Acquired | • Forehead/head 21<br>EEG channels | • Up to 20 EEG scalp<br>channels<br>• 3-D actigraphy<br>• 4 optional single channel<br>either dual lead EOG or<br>EMG<br>• Single optional ECG<br>channel | • EEG, EMG signals<br>• EP | | CMRR | 115dB | 110dB | N/A | | Input<br>Impedance | 1Gohm | 100Gohm | N/A | | Power Supply | 2 x 2300mAH 3.7V Li-<br>Ion batteries | 2 to 4 X 240mAH 3.7 Li-Ion<br>batteries | N/A | | Battery<br>Charging | Operators - external<br>battery pack | Via JED Connector<br>connected to USB port or<br>USB wall charger | N/A | | Typical<br>Charging Time | 0.5-3.0 hours depending<br>of discharge depth | 0.5-5.0 hours | NA | | Acquisition<br>modes | Record | Monitor only | N/A | | Operating Time | 4.0 hours | Monitoring Days after<br>Charge Hours of Use<br>• 0-4 Days: 16 to 17<br>hours<br>• 5-10 Days: 14 to 15<br>hours | N/A…