Who is the manufacturer of Neuronaute?

Bioserenity Sas filed the 510(k) submission for Neuronaute (K202334).

What is the FDA product code for Neuronaute?

GWQ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Neuronaute?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Neuronaute?

AE-120A EEG Head Set (K183529).

Who can help prepare an FDA 510(k) submission like Neuronaute?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Neuronaute

K202334 · Bioserenity Sas · GWQ · Dec 10, 2020 · Neurology

Device Facts

Record ID	K202334
Device Name	Neuronaute
Applicant	Bioserenity Sas
Product Code	GWQ · Neurology
Decision Date	Dec 10, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

Indications for Use

Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis.

Device Story

System acquires EEG signals via full montage array (up to 24 channels) using cutaneous electrodes; data stored locally on Head Module; transmitted via Wi-Fi to N-CLOUD for remote physician review. Components include Head Module, High Capacity Battery, BioAdapter, N-WAY router, N-DEO camera (optional), and N-CLOUD platform. Operated by trained medical professionals (doctors, nurses, technicians) in clinics, hospitals, or remote locations. Mobile app manages recording sessions. Device provides raw EEG data for clinical interpretation; no automated diagnostic conclusions or alerts. Benefits include remote monitoring capability and high-resolution signal acquisition to support neurological diagnosis.

Clinical Evidence

No clinical testing was submitted. Substantial equivalence is supported by bench testing, including electrical safety, EMC, software verification/validation, usability testing, and biocompatibility.

Technological Characteristics

EEG system with up to 24 channels; 10/20 montage; 250/500 Hz sampling rate; 24-bit ADC; >1Gohm input impedance; >105 dB CMRR. Materials: Silver/polyimide electrodes. Connectivity: Wi-Fi/Bluetooth. Power: 3.7V LiPo battery. Standards: IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-26, ISO 10993-1/5/10, IEC 62304.

Indications for Use

Indicated for adult patients (ages 18+) under medical supervision to acquire, display, store, and transmit EEG signals to assist physicians in diagnosing neurological disorders.

Regulatory Classification

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.

Predicate Devices

AE-120A EEG Head Set (K183529)

Reference Devices

EEG-1200A series (K080546)
EEG-9100 (K011204)
Technomed Europe reusable cup electrodes (K072016)
Elefix conductive electrolyte paste (K860210)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 10, 2020 Bioserenity SAS Julien DUPONT Ouality and Regulatory Affairs Director ICM-iPEPS 47 Boulevard de l'Hopital 75013 Paris, France Re: K202334 Trade/Device Name: Neuronaute Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GXY Dated: July 30, 2020 Received: September 11, 2020 Dear Julien DUPONT: 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. 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 located 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. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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). Sincerely, for 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202334 Device Name Neuronaute #### Indications for Use (Describe) Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------|--------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ # K202334 Neuronaute ## Traditional 510(k) Summary Prepared in accordance to the content and format outlined in 21 CFR 807.92 ### Submitter Information | Submitter's Name: | BioSerenity SAS | |----------------------|---------------------------------------------------------------| | Submitter's Address: | ICM-iPEPS 47 Boulevard de l'Hôpital 75013 Paris, France | | Telephone: Fax: | +33 683 970 625 +33 186 953 093 | | Contact Person: | Julien DUPONT E-mail: julien.dupont@bioserenity.com | | US Contact Person: | Joe COTY E-mail: joe.coty@bioserenity.com | | US Telephone: | (803)466-2436 | |------------------------------|-------------------| | Date of Summary Preparation: | December 09, 2020 | ## Subject Device Information | Trade Name: | Neuronaute | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Electroencephalograph (EEG) | | Classification Name: | Electroencephalograph | | Primary Product Code: | GWQ - Full-montage standard electroencephalograph | | Intended Use: | The subject device is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user- specified locations in order to assist in the diagnosis of neurological disorders by a physician. | | Regulation Number: | 21 CFR 882.1400, Electroencephalogram | | Device Class: | II | {4}------------------------------------------------ #### Predicate Device Information | K183529 | | |----------------------|---------------------------------------------------------| | Device Name | AE-120A EEG Head Set | | Manufacturer | Nihon Kohden Corporation | | Primary Product Code | OMC; reduced- montage standard electroencephalograph | | Regulation number | 21 CFR 882.1400 | | Device Class | II | | Clearance Date | 03/19/2019 | #### Subject Device Description Neuronaute allows up to 24 channels EEG monitoring. It includes the following components: #### Neuronaute Head Module removable recorder composed of an electronic card in a plastic case. It connects to the Neuronaute BioAdapter using snap buttons located on its rear. The data from the Head Module is uploaded to a secure cloud platform. The data acquired during a recording is stored locally on the Head Module recorder. #### Neuronaute High Capacity Battery Module removable and rechargeable electronic device. The battery is recharged using the Neuronaute Battery charger. The Neuronaute High Capacity Battery module connects to the Neuronaute Bio-Adapter using snap buttons located on its rear. #### Neuronaute BioAdapter enables the connection of the Neuronaute Head Module and the Neuronaute High Capacity battery module to the Neuronaute IceCap or a specific set of reusable cup electrodes manufactured with Ag/AgCl discs connected to a lead wire. The wire is insulated and terminates with a touch proof connector (DIN 42802) - equivalent to the reusable cup electrodes from Technomed Europe, FDA cleared under the 510k number K072016 in order to record and transmit data to the cloud platform. #### Neuronaute Mobile App The mobile application associated with the system which enables healthcare professionals to access and manage the prescribed recording sessions. It is compatible with iOS systems. {5}------------------------------------------------ #### Neuronaute N-CLOUD A web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals. The physician, who prescribes the use of the Neuronaute system, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud by testing this connection and use as outlined in the user manual. #### Neuronaute N-DEO A camera enabling the visualization of the patient during a recording. The IP camera provides HD resolution video sequence at 1080p, with advanced night mode and WDR technology. #### Neuronaute N-WAY a router module enabling flexible connectivity for remote monitoring and data transmission to the cloud platform. #### Neuronaute IceCap a single-use headset containing 21 electrodes which is connected to the Neuronaute Head Module via the IceAdapter, the DB25 cable, and the Neuronaute BioAdapter. ### Target population The target patient population for the Neuronaute is adult patients, ages 18 and above. ### Comparison to Predicate Device The Neuronaute and the predicate device, AE-120A EEG Head Set, have the same intended use. Both devices use an integrated array of cutaneous electrodes to obtain a recording of EEG signals to aid clinicians in the diagnosis of neurological disorders. The characteristics of the subject device and the predicate device are summarized in the following table and differences in technological characteristics do not raise different questions of safety and effectiveness. {6}------------------------------------------------ The table below provides a summary of the technological characteristics of the subject device in comparison to those of the predicate device. | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Trade Name | Neuronaute | AE-120A EEG Head Set | | | Manufacturer | BioSerenity SAS | Nihon Kohden Corporation | | | 510(k) Number | K202334 | K183529 | | | Primary Product Code | GWQ; Full montage standard EEG (16 or more electrodes) | OMC; Reduced montage standard EEG (less than < 16 electrodes) | Similar; both product codes fall under the same regulation 882.1400 | | Secondary Product Code | GXY | GXY (cutaneous electrode) | Same | | Indications for Use | | | Similar | | Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition. The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with | The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition. The device is intended for use by trained medical professionals in a medical facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above) | | Wording differences that include descriptions of the device functions do not change the intended use | | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | | | healthcare providers. The system data should not be used alone but should be used along with all other clinical data and exams to come to a diagnosis. | | | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | |--------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended User(s) | Trained healthcare professionals: doctors, polysomnogram technicians, and nurses | Trained medical professionals | Similar Both devices are used by trained healthcare users. The subject device has passed the usability tests for the intended users | | Type of use | Prescription | Prescription | Same | | Environment of use | Physician's office, hospital or other remote locations under medical supervision. | Medical facility such as a physician's office, laboratory, or clinic | Similar Both devices are intended to be used in an environment that includes medical and trained supervision. | {10}------------------------------------------------ | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | |----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Video | Optional; The subject device includes a component video camera called N-DEO | No | Different The subject device can be used with a camera which is not the case for the predicate device. The subject device has passed the essential performance and usability requirements to account for the introduction of this technological characteristic. | | Electrode Components | | | | | Type of patient Contacting components included with the device | Electrodes and gel contact patient's scalp | Electrodes and gel contact patient's scalp | Same | | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | | Electrodes | Up to 21 electrodes: • 19 EEG electrodes • 1 FpZ used for ground connection • An Oz electrode is used as a reference for EEG calculation | 10 electrodes (8 EEG electrodes, 1 reference electrode, 1 Z electrode) | Similar Both devices have sufficient number of electrodes for EEG monitoring. The subject device meets the performance requirements outlined in IEC 60601-2-26 (input noise) to account for this difference. | | Material Composition | Silver & polyimide | Ag/AgCl electrodes | Similar The subject device meets the biocompatibility requirements outlined in ISO 10993-1 to account for this difference. | | Electrodes; single or reusable? | Single use, non-sterile | Single use, non-sterile | Identical Both devices are single use, non-sterile and disposable. | | Montage | 10/20 System | 10/20 System | Same | | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | | Able to accommodate different patient head sizes | The material of the Neuronaute IceCap stretches such that it can fits on the patient's head, similar to a sock | AE-120A EEG Head Set has flexible arms that are adjusted to fit different adult patient head sizes along with adjustments from the belts/ straps (chin) | Similar | | Conductive Electrolyte gel | Conductive electrolyte paste put in the central hole of each electrode, cleared in K860210 Elefix. | Conductive electrolyte paste is included in a packet gel reservoir integrated into each electrode. User inserts electrode into the electrode attachment position in Head Set with paste | | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | |--------------------|---------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EEG channels | Up to 24 channels | 8 | Similar Both devices have sufficient number of EEG channels for EEG monitoring. CDRH has cleared other EEG systems with 24 Channels under 882.1400: K170441and K010460. | | Data format | EDF | Nihon Kohden original format | Similar The subject device provides the data in the standard format used by the healthcare. Therefore, this difference does not raise any different questions of safety or effectiveness. | {14}------------------------------------------------ | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | |--------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sampling Rate | 250 or 500 Hz | 200 Hz | Similar The subject device acquisition frequency is higher than the predicate device. Consequently, the subject device has a better accurate signal. Therefore, this difference does not raise any different questions of safety or effectiveness. | | | | Recorder Component | | | Wireless Output | WiFi 2,4GHz Bluetooth 2,4GHz | Bluetooth 2.4 GHz | Similar Both devices include wireless communication. The subject device conforms with IEC 60601-1, IEC 60601- 2 and FCC PART 15B requirements. | | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | | Input dynamic range and differential offset voltage | ±400mV | ±500 mV or more | Similar The subject device conforms with IEC 60601-2-26 requirements to account for this difference. | | ADC Resolution | 24 bits | 12 bits | Similar The subject device has an improved ADC resolution. | | ADC Common Mode Rejection Rate (CMRR) | > 105 dB | 90 dB or more | Similar The subject device conforms with the 60601-2-26 requirements and has a better ADC CMRR to account for this difference. | | Input Impedance | > 1Gohm | 1200 Mohms | Similar The subject device conforms with the 60601-2-26 requirements. | | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | | Input noise | $< 6µVp-p over 0.1-50Hz$ | $5 µVp-p$ or less (0.53 to 60 Hz) | Similar The subject device conforms with the 60601-2-26 requirements. | | Electrode impedance check | Yes | Yes | Same | | General System Characteristics | | | | | Power source | Battery | Same | | | Type of battery | Rechargeable LiPo (Lithium Polymer) 3.7-volt, 2.4 Ah | 2 AA (LR6) alkaline batteries (not rechargeable) | Similar The subject device conforms with FDA-recognized electrical safety standards. | | Battery dimensions | Neuronaute High Capacity Battery module: 199,5 x 170,6 x 27,2 mm | 56 W x 43 H × 151 D mm | Similar The batterie subject device is used with the BioAdapter. The battery dimensions have no impact in the use of device for the patient. | {15}------------------------------------------------ {16}------------------------------------------------ {17}------------------------------------------------ | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | |--------------------|--------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Weight | • Neuronaute High Capacity Battery module: 147 g | 240 g (without the belts, forehead pad and batteries) | Similar The battery subject device is used with the BioAdapter. The battery weight has no impact in the use of device for the patient. | {18}------------------------------------------------ | System components | ● | Neuronaute Head Module | | Works only with Nihon Kohden specified EEG's: EEG-1200A series (K080546) EEG-9100 (K011204) | Similar Both subject and predicate devices are intended to be connected to external EEG recording devices. The predicate device meets the usability requirements to achieve the intended use. | |-------------------|---|-------------------------------------------------------------|----|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ● | Neuronaute IceCap | | | | | | ● | Neuronaute IceAdapter | | | | | | ● | Neuronaute BioAdapter | | | | | | ● | Neuronaute Battery | | | | | | ● | Neuronaute N-WAY | N- | | | | | ● | Neuronaute N-DEO | N- | | | | | ● | Neuronaute® N-CLOUD | N- | | | | | ● | Neuronaute® Mobile APP | | | | | | ● | Standard cup electrodes to be used with the BioAdapter (not | | | | {19}------------------------------------------------ | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | |----------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | supplied by BioSerenity). BioSerenity recommends the use of FDA cleared EEG cup electrodes only | | | | EEG Software | The Neuronaute System contains a software which enables collecting and communicating EEG data. | AE-120A EEG Head Set comes with EEG-compatible software for interaction with and viewing of EEG data | Similar The subject device has been developed in accordance with the IEC 62304 and usability requirements. | | Connectors | Snap buttons on the Neuronaute Head Module and the battery Neuronaute IceAdapter DB25 cable Touch proofs | Single connector of electrodes to AE- 120A Head Set | Similar | | Item of Comparison | Subject Device K202334 | Predicate Device K183529 | Comment | | Electrical Safety & EMC | • IEC 60601-1 • IEC 60601-1-2 • IEC 60601-1-11 • IEC 60601-2-26 | • IEC 60601-1 • IEC 60601-1-2 • IEC 60601-2-26 | Similar Both devices conform to the relevant standards. As the subject device can be used at home under supervision of a healthcare professional, IEC 60601-1-11 requirements have been added to allow for use in this environment. | | Biocompatibility | Neuronaute IceCap and electrode gel paste (K860210) conform to ISO 10993-5 and ISO 10993-10 | Patient contacting components verified with Cytotoxicity, Sensitization, and Irritation per ISO 10993-5 and ISO 10993-10 (or previous clearance or previous use of material/processing for same patient contact and duration). These components include: electrodes, electrode gel, paste | Same The subject device meets the biocompatibility requirements outlined in 10993-1 relevant to the patient contacting type, according to the risk profile of the device. | {20}------------------------------------------------ {21}------------------------------------------------ #### Performance Testing #### Non-clinical Performance Testing In order to demonstrate the substantial equivalence between Neuronaute and the predicate, bench testing was carried out on the following characteristics: - Electromagnetic compatibility (EMC) - - Electrical safety testing - - -EEG signal quality - Software verification and validation testing - - Usability testing - - -Biocompatibility Neuronaute was tested and meets the requirements of following: - AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - -IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance collateral standard: Electromagnetic compatibility - requirements and tests - IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: -General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - EC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs In order to demonstrate the signal quality, BioSerenity has compared the Neuronaute device with EEG gold standards. The firmware in Neuronaute Head Module, Neuronaute mobile application and Neuronaute Cloud have been tested through verification and validation procedures according to the IEC 62304: 2006/A1:2016 standard and as per the FDA Guidance "General Principles for Software Validation". The results of the verification and validation activities demonstrate that the software meets the requirements for safety, functionnal and intended use. BioSerenity has carried tests according to the IEC 62366 standard and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)". The objective was to assess the usability within the overall human factors engineering process and to identify any potential risks related to the use of the device. The tests have {22}------------------------------------------------ demonstrated all the points listed above do not raise any new questions of safety or effectiveness for the Neuronaute intended purposes. #### Clinical Performance Testing No clinical testing was submitted to determine substantial equivalence. #### Conclusion Neuronaute and the predicate device, K183529 AE-120A EEG Head Set, have the same intended use. Differences in technological characteristics do not raise different questions of safety and effectiveness to achieve the intended use and the performance testing submitted to evaluate these differences are acceptable to demonstrate substantial equivalence to the predicate device.

Neuronaute

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