(182 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on signal acquisition, storage, transmission, and basic analysis/filtering, without mentioning any AI/ML algorithms for interpretation or diagnosis.
No
The device is intended to acquire, store, and transmit physiological signals and assist in the diagnosis of neurological disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders." It also mentions that the BioSerenity Cloud allows the display and analysis of signals to "aid doctors in diagnosing neurological disorders."
No
The device description clearly lists multiple hardware components, including a signal acquisition system (Core module), extenders, a holding band, electrode headsets (IceCap, IceCap 2 & 2 Small), and a VEEG pack with a camera and wireless connectivity device. While it includes software components (Mobile APP, CLOUD), it is not solely software.
Based on the provided information, the Neuronaute Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Neuronaute Plus Function: The Neuronaute Plus acquires, stores, and transmits physiological signals from the brain (EEG, ECG, EMG, EOG, breathing). It does not analyze specimens derived from the human body.
- Intended Use: The intended use is to assist in the diagnosis of neurological disorders by providing physiological signal data for review and analysis by healthcare professionals. It explicitly states that it "do not provide any diagnostic conclusions or automated alerts of an adverse clinical event."
- Device Description: The device description confirms it's a non-invasive system for acquiring and recording electrophysiological signals.
Therefore, the Neuronaute Plus falls under the category of a medical device that collects physiological data, rather than an In Vitro Diagnostic device that analyzes biological specimens.
N/A
Intended Use / Indications for Use
The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological 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 BioSerenity Cloud.
The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.
The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver.
Adequate training is recommended for proper use of the device.
Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm.
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.
The BioSerenity Cloud allows the display of signals in the diagnosis of physiological disorders through the data collected by recording.
The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.
Product codes
GWQ, GXY
Device Description
The Neuronaute Plus is a non-invasive medical device which enables the acquisition, recording, storage and transmission of electrophysiological signals in order to analyze potential neurological disorders.
The system is composed of the pieces of equipment listed below, and the Neuronaute Plus components are connected through Bluetooth and Wi-Fi.
- -Neuronaute Plus (Core module): is a signal acquisition system: an electronical amplifier that records EEG, ECG, EMG, EOG and breathing signals via a connection to EEG caps which transmits the data to the Neuronaute mobile application and Cloud system.
- -Neuronaute Plus IceCap extender : is a removable interface to connect the signal acquisition system to the IceCap and IceCap2 & 2 Small.
- -Neuronaute Plus DB25 Extender : is a removable interface that can connect the signal acquisition system to any DB25-compatible EEG cap.
- -Holding band : is a wearable textile band which allows the patient to place the Neuronaute Plus close around his chest over clothes. the use of the holding band is optional.
- -Neuronaute IceCap: is a single use 21 electrode headset that connects to the Neuronaute Head Module via the IceAdapter, the DB25 cable and the Neuronaute BioAdapter, or Neuronaute Plus with its IceCap Extender. Recently, the Neuronaute Touchproof Adapter was developed to connect the IceCap electrode to Neuronaute Head module via a touchproof channel.
- Neuronaute IceCap 2 & 2 Small: recently cleared version of the IceCap dedicated to adults and pediatric patients. It connects similarly to Neuronaute and Neuronaute Plus.
- Neuronaute Mobile APP: is compatible with iOS systems. The mobile application enables the healthcare professionals to access and manage the prescribed recording sessions.
- -Bioserenity CLOUD: is 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 this device, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud.
- -VEEG pack: it is composed of the Neuronaute N-DEO and Neuronaute N-WAY. The Neuronaute N- DEO camera enables 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. The Neuronaute N- WAY enables wireless connectivity (4G) for remote monitoring and data transmission to the cloud platform.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain, head, scalp
Indicated Patient Age Range
patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver.
Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm.
Intended User / Care Setting
trained healthcare professionals, technicians or patients; physician's office, hospital, or other remote locations. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Human factors studies have been performed according to the IEC 62366-1 standard and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)" for Neuronaute Plus. The objective is to assess the usability within the overall human factors engineering process and to identify any potential risks related to the use of the Neuronaute Plus and prove that it is substantially equivalent to Neuronaute.
Usability tests were performed on two user groups:
- -User group 1: Health care professionals (Physicians, nurses, technicians) => n=9
- User group 2: Patients (15-30 years; 31-50 years; >50 years) => n=15 ।
Two configurations of the device system were tested: the entire Neuronaute Plus system associated with IceCap 2 electrodes and its corresponding extender, or the entire Neuronaute Plus with Micromed Cap electrodes associated with its DB25 extender.
The protocol was conducted in four main steps: a training, a study and session presentation (Oral information provided by the test personnel about the purpose of the evaluation), the usability tests, and a debriefing step.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety:
The electrical safety tests were performed by EMITECH for Neuronaute Plus according to :
- 60601-1:2005/AMD1:2012, 60601-1:2005, IEC 60601--IEC IEC 1:2005/AMD2:2020
- -IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 for use in conjunction with IEC 60601-1:2005, IEC 60601- 1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020
- IEC 80601-2-26:2019 for use in conjunction with IEC 60601-1:2005. -AMD1:2012, AMD2: 2020
All tests done for electrical safety tests are in passed status. We conclude that Neuronaute Plus appear to demonstrate substantially equivalent electrical safety to its predicate Neuronaute.
EMC tests:
The testing has been performed according to the following standard IEC 60601-1-2: 2014 + A1 (2020). According to the final report of the laboratory, the product fulfills the requirements of the standard like its predicate Neuronaute. All tests done by the laboratory are passed. The system used for EMC tests is substantially equivalent to Neuronaute system and demonstrates EMC substantial equivalence to the of Neuronaute Plus.
Wireless safety and likelihood of wireless coexistence:
These tests ensure radio-emission safety of Neuronaute Plus due to the implementation in its core module of WiFi (4G) and BLE modules like its predicate Neuronaute Head module. But additionally, those tests ensure the safety of Neuronaute Plus according to this main design change that consists of the WiFi 5G integration and the ability of the patient to wear Neuronaute Core Module by the patient within 20 centimeters of their body through the use of the Neuronaute Plus Holding Band. All the tests on radio-emission safety are passed. Therefore the adding of WiFi 5G module in the Neuronaute Plus core module do not appear to affect the safety or performance of Neuronaute Plus and remains substantially equivalent to Neuronaute. Concerning the wireless functions (BLE and WiFi) of Neuronaute Plus, a safety risk analysis and likelihood of wireless coexistence tests allow us to conclude that Neuronaute Plus has demonstrated substantial equivalence to its predicate.
Programmable Electrical Medical System (PEMS):
The PEMS requirements have been implemented and tested for ensuring safety and electrical performance of Neuronaute Plus according to the IEC 60601-1:2005. IEC 60601-1:2005/AMD1:2012, IEC 60601- 1:2005/AMD2:2020 and IEC 62304:2007/A1: 2015 standard. All tests addressing the electrical safety of the Neuronaute Plus firmware have been performed and are in PASSED status. Because the firmware includes new features like data storage for more 24h, battery level checking, patient event button, etc. more tests have been performed to ensure its safety. The difference in the number of tests between Neuronaute Plus and Neuronaute ensures an increased coverage of Firmware functionality safety compared to the predicate. Testing demonstrates substantial equivalence between the predicate and Neuronaute Plus.
Cybersecurity:
According to the risk management file and cybersecurity FDA guidance, the design process allows to demonstrate the safety and the performance of the cybersecurity aspect for NEURONAUTE PLUS. To manage future unknown threats that would appear in all life cycle of NEURONAUTE PLUS, a cybersecurity post-market surveillance plan is implemented.
Biocompatibility:
Based on the analysis of literature which covers raw materials. OEKO-TEX certificates that ensures the safety of used textiles taking into account manufacturing adjuvants, and the standard ISO 10993-1. no further testing is required for the evaluation of Neuronaute Plus biocompatibility. The risks associated with the product are considered very low in regard to its components, its use by the patient and the limited skin contact duration. Regarding the type and duration of skin contact, Neuronaute Plus and its accessories satisfy the requirements of ISO 10993-1 and FDA and can therefore be classified as a biocompatible device. This confirms that Neuronaute Plus biocompatibility is substantially equivalent to the predicate Neuronaute even including the new accessory, the holding band. This confirms the substantial equivalence between Neuronaute Plus and its predicate.
Usability:
Human factors studies have been performed according to the IEC 62366-1 standard and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)" for Neuronaute Plus. The objective is to assess the usability within the overall human factors engineering process and to identify any potential risks related to the use of the Neuronaute Plus and prove that it is substantially equivalent to Neuronaute.
Usability tests were performed on two user groups:
- -User group 1: Health care professionals (Physicians, nurses, technicians) => n=9
- User group 2: Patients (15-30 years; 31-50 years; >50 years) => n=15
Two configurations of the device system were tested: the entire Neuronaute Plus system associated with IceCap 2 electrodes and its corresponding extender, or the entire Neuronaute Plus with Micromed Cap electrodes associated with its DB25 extender.
The protocol was conducted in four main steps: a training, a study and session presentation (Oral information provided by the test personnel about the purpose of the evaluation), the usability tests, and a debriefing step.
The results of this evaluation have shown that the validation criteria are met with no use errors leading to critical or major risks that may lead to harm occurred during this evaluation, and the pre assessment of tested risks that did not result in new critical or major risks.
The usability testing conducted supports substantial equivalence of the Neuronaute Plus compared to its predicate.
Battery:
The battery included in the Neuronaute Plus core module is compliant by design to the IEC 62133 ed. 2.
In addition to this compliance, electrical safety tests on the system itself (including the battery and, for specific requirements, on the battery alone on its charger) were performed for Neuronaute Plus according to:
- -IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020
- IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 -
- -IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 for use in conjunction with IEC 60601-1:2005, IEC 60601- 1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020
All tests done for electrical safety tests on battery are in "passed" status.
We conclude that Neuronaute Plus appears to demonstrate substantially equivalent electrical safety to its predicate, Neuronaute.
Clinical tests:
No clinical data was needed for demonstrating substantial equivalence of the Neuronaute Plus.
Conclusion:
All main concerns of new risks following the development of Neuronaute Plus compared to Neuronaute and Neuronaute with IceCap 2 & 2 Small was assessed in this document. According to these results described above, we have demonstrated substantial equivalence of Neuronaute Plus with its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
November 9, 2023
Image /page/0/Picture/1 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, 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.
BioSerenity SAS Madubuike Okafor Director of QMS & Regulatory Affairs for US Medical Devices 47, avenue de l'Hôpital ICM-iPEPS Paris, 75013 France
Re: K231366
Trade/Device Name: Neuronaute Plus Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GXY Dated: Mav 9, 2023 Received: May 11, 2023
Dear Madubuike Okafor:
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"
1
(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).
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 OS 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.
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 mediation-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.
Image /page/1/Picture/7 description: The image shows the name "Patrick Antkowiak -S" in black text on a white background. To the left of the name is the acronym "FDA" in a light blue color. The acronym is large and bolded.
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical,
2
Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231366
Device Name Neuronaute Plus
Indications for Use (Describe)
The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological 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 BioSerenity Cloud.
The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.
The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver.
Adequate training is recommended for proper use of the device.
Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm.
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.
The BioSerenity Cloud allows the display of signals in the diagnosis of physiological disorders through the data collected by recording.
The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K231336 Neuronaute Plus
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: | 47, avenue de l'Hôpital |
| ICE-iPEPS | |
| Paris, 75013 France | |
| Telephone: | 347-507-6722 |
| Contact Person: | Madubuike OKAFOR |
| Email: | Madubuike.okafor@bioserenity.com |
Subject Device Information
| Trade Name: | Neuronaute Plus |
|---|---|
| Common Name: | Electroencephalograph (EEG) |
| Classification Name: | Full-Montage Standard Electroencephalograph |
| Primary Product Code: | GWQ |
| Intended Use: | The Neuronaute Plus is a system intended to acquire, |
| store, archive, and periodically transmit physiological | |
| signals from the brain using a full montage array to | |
| enable review at a physician's office, hospital, or other | |
| remote locations. The Neuronaute Plus and its | |
| associated software are intended to assist in the | |
| diagnosis of neurological disorders. | |
| Regulation Number: | 21 CFR 882.1400, Electroencephalogram |
| Device Class: | II |
| Secondary Product | |
| Code: | GXY |
Predicate Device Information
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| K202334 | |
|---|---|
| Device Name | Neuronaute |
| Manufacturer | BioSerenity SAS |
| Primary Product Code | GWQ |
| Regulation number | 21 CFR 882.1400 |
| Device Class | II |
| Clearance Date | 12/10/2020 |
Intended Use/Indications for Use
The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological 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 BioSerenity Cloud.
The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.
The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver.
Adequate training is recommended for proper use of the device.
Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm.
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.
The BioSerenity Cloud allows the display of signals in order to help aid in the diagnosis of physiological disorders through the data collected by recording.
The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.
Indications for Use Comparison
Indication for use comparison between Neuronaute Plus and its predicates:
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The indication for use is similar. Both devices are intended to assist the diagnosis of neurological disorders by remotely recording EEG signals.
According to the Neuronaute with IceCap 2 and 2 Small, the Neuronaute recorders themselves are intended on patients of all ages.
Age restrictions are still applicable according to the electrodes used for EEG recordings (the IceCap can only be used on adults (age 18 and over), but IceCap 2 can be used on adults and pediatrics patients).
Neuronaute Plus introduces the patient as an intended user of the recorder. This change according to consensus standard does not affect the substantial equivalence of Neuronaute Plus compared to its predicate.
Neuronaute was already compliant to the patient's home use even though it was not stated in its indication for use.
Electrical and EMC safety tests were performed according to the IEC 60601-1-11 (home use) and IEC 60601-1 consensus standards and tests conclude that the Neuronaute Plus and its predicate comply with the standards.
No other risks have been identified linked to its new environment of use.
These differences do not appear to affect the substantial equivalence of Neuronaute Plus compared to its predicate device.
Device Description
The Neuronaute Plus is a non-invasive medical device which enables the acquisition, recording, storage and transmission of electrophysiological signals in order to analyze potential neurological disorders.
The system is composed of the pieces of equipment listed below, and the Neuronaute Plus components are connected through Bluetooth and Wi-Fi.
- -Neuronaute Plus (Core module): is a signal acquisition system: an electronical amplifier that records EEG, ECG, EMG, EOG and breathing signals via a connection to EEG caps which transmits the data to the Neuronaute mobile application and Cloud system.
- -Neuronaute Plus IceCap extender : is a removable interface to connect the signal acquisition system to the IceCap and IceCap2 & 2 Small.
- -Neuronaute Plus DB25 Extender : is a removable interface that can connect the signal acquisition system to any DB25-compatible EEG cap.
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- -Holding band : is a wearable textile band which allows the patient to place the Neuronaute Plus close around his chest over clothes. the use of the holding band is optional.
- -Neuronaute IceCap: is a single use 21 electrode headset that connects to the Neuronaute Head Module via the IceAdapter, the DB25 cable and the Neuronaute BioAdapter, or Neuronaute Plus with its IceCap Extender. Recently, the Neuronaute Touchproof Adapter was developed to connect the IceCap electrode to Neuronaute Head module via a touchproof channel.
- Neuronaute IceCap 2 & 2 Small: recently cleared version of the IceCap dedicated to adults and pediatric patients. It connects similarly to Neuronaute and Neuronaute Plus.
- Neuronaute Mobile APP: is compatible with iOS systems. The mobile application enables the healthcare professionals to access and manage the prescribed recording sessions.
- -Bioserenity CLOUD: is 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 this device, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud.
- -VEEG pack: it is composed of the Neuronaute N-DEO and Neuronaute N-WAY. The Neuronaute N- DEO camera enables 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. The Neuronaute N- WAY enables wireless connectivity (4G) for remote monitoring and data transmission to the cloud platform.
Technological Comparison
Technical characteristics difference:
Electrode components:
None. Neuronaute Plus is compatible with both electrodes (IceCap and IceCap 2). Neuronaute Plus remains substantially equivalent to its predicates on electrode characteristics.
Type of recorded signals and channels:
Input signals are similar. From up to 28 unipolar channels including channels for the reference and the ground and 2 bipolar channels for Neuronaute, Neuronaute Plus counts 29 unipolar and 2 bipolar channels. The number of channels as well as their
8
specific design for Neuronaute Plus (reference and ground channel directly integrated into the extender channels) were tested according to the consensus standards for ensuring the electrical, EMC and usability safety. Validation tests on the complete system with compatible electrodes and EEG viewer software (Neuronaute app mobile and Bioserenity Cloud) were performed to validate the performance of the system according to tests similar to the Neuronaute system, its predicate.
Therefore the difference does not appear to affect the substantial equivalence of Neuronaute Plus compared to the predicate device.
Recorder component:
The wireless outputs are different from the predicate (the Neuronaute Plus includes WIFI 5G). Radioemission safety tests were performed according to the 60601-1, 60601-1-2, CFR 47 Part 15 Subpart B - Radio frequency devices - Unintentional radiators 2021, and ANSI 63.4 of 2014.
The tests successfully passed, therefore the difference does not appear to affect the essential performance of the subject device.
Firmware:
New features implemented to adapt to the design of Neuronaute Plus core module:
- Battery level indicator -
- -Patient event button
- -Data storage up to 72h without WiFi connection (offline mode)
Tests of verification and validation according to consensus standard and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and General Principles of Software Validation" were performed to ensure the safety and the effectiveness of new features contained in the firmware of Neuronaute Plus. The tests are similar to those performed for Neuronaute firmware.
Therefore the difference does not appear to affect the substantial equivalence of Neuronaute Plus compared to its predicate.
Battery:
The design of the battery in Neuronaute Plus is different compared to Neuronaute; it has different performance specifications compared to the predicate battery (lighter, more compact but same autonomy), and it is removable from Neuronaute Plus core module. The Neuronaute Plus design with its internal removable battery was tested according to consensus standards for ensuring the electrical, EMC and usability safety. Validation tests covering complete system with compatible electrodes and EEG viewer software (Neuronaute app mobile and Bioserenity Cloud) were performed to validate the performance of the system according to tests that were similar to the Neuronaute system, its predicate. Therefore, the difference does not affect the substantial equivalence of Neuronaute Plus compared to its predicate device.
Accessories to connect Neuronaute Plus to the electrodes:
With Neuronaute Plus, it is possible to plug 2 different extenders to connect to:
- IceCap or the IceCap 2 (via the IceCap Extender)
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- Micromed EEG Cap electrodes via DB25 extender -
The Neuronaute Plus design with its extenders on channels was tested according to consensus standards for ensuring the electrical, EMC and usability safety. Validation tests on the complete system with compatible electrodes and EEG viewer software (Neuronaute mobile app and Bioserenity Cloud) were performed to validate the performance of the system according to tests similar to the Neuronaute system, its predicate.
The biocompatibility of the holding band (textile) and the Neuronaute Plus casing materials was assessed and shows no biocompatibility risks sufficient to need supplemental tests, allowing to conclude it is a biocompatible device for the patient.
Therefore, the difference does not appear to affect the substantial equivalence of Neuronaute Plus compared to its predicate.
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The table below provides a summary of the technological characteristics of the subject device in comparison to those of the predicate device.
| Device & Predicate
Device(s): | Subject Device
Neuronaute Plus
K231366 | Predicate Device
Neuronaute
K202334 | Reference Device
Neuronaute with
IceCap 2 & 2 Small
K223644 |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BioSerenity SAS | BioSerenity SAS | BioSerenity SAS |
| Product Codes | GWQ
(Electroencephalograph)
GXY (Cutaneous
electrodes) | GWQ
(Electroencephalograph)
GXY (Cutaneous
electrodes) | GWQ
(Electroencephalograph)
GXY (Cutaneous
electrodes) |
| Software Analysis | It allows remote access
for users via the
BioSerenity Cloud
which receives
physiological signals
from Neuronaute Plus
(which sends
transmissions to the
cloud). | 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. | 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. |
| Video | Optional; The subject
device includes a
component video
camera called N-DEO. | Optional; The subject
device includes a
component video
camera called N-DEO. | Optional; The subject
device includes a
component video
camera called N-DEO. |
| Types of patient-
contacting components | EEG cap electrodes and
gel are in contact with
patient's scalp.
Neuronaute Plus is
compatible with both
types of electrodes
(IceCap and IceCap 2). | EEG cap electrodes and
gel are in contact with
patient's scalp.
IceCap
- Polyimide substrate
- EEG conductive paste | EEG cap electrodes and
gel are in contact with
patient's scalp.
IceCap 2 & 2 Small: - Silicone adhesive
- Dielectric ink
- EEG Conductive
pastes |
| Electrodes | Up to 21 electrodes: - 19 EEG electrodes
- 1 electrode (Fpz) used
for ground connection - 1 electrode (Oz) used
as a reference for EEG
calculation | Up to 21 electrodes: - 19 EEG electrodes
- 1 electrode (Fpz) used
for ground connection - 1 electrode (Oz) used
as a reference for EEG
calculation | Up to 21 electrodes: - 19 EEG electrodes
- 1 electrode (Fpz) used
for ground connection - 1 electrode (Oz) used
as a reference for EEG
calculation |
| Material Composition | Neuronaute Plus is
compatible with both
types of electrodes
(IceCap and IceCap 2). | IceCap - Polyimide
- Copper covered with a
layer of silver | IceCap 2 & 2 Small: - Polyethylene
terephthalate (PET) - Silver and Silver/Silver
chloride conductive inks - Insulation inks
- Stiff PETG film
- Skin adhesive
- Graphical ink |
| Device & Predicate
Device(s): | Subject Device
Neuronaute Plus
K231366 | Predicate Device
Neuronaute
K202334 | Reference Device
Neuronaute with
IceCap 2 & 2 Small
K223644 |
| Single vs Multi-Use | Single use, non-sterile | Single use, non-sterile | Single use, non-sterile |
| Montage | 10/20 System | 10/20 System | 10/20 System |
| Able to accommodate
different head sizes | Neuronaute Plus is
compatible with both
types of electrodes
(IceCap and IceCap 2). | IceCap
The material of the
Neuronaute IceCap
stretches such that it
can fits on the patient's
head, similar to a sock.
The unique cap size fits
to at least 90% of the
population. | IceCap 2 & 2 Small:
The material of the
Neuronaute with IceCap
2 & IceCap 2 Small
stretches to fit the
patient's head.
It's provided in two
sizes depending on the
head circumference of
the patient: - Head circumferences
between 43 and 53 cm:
use the IceCap 2 Small - Head circumference
between 53 and 60 cm:
use the IceCap 2
The IceCap 2 is used
when the patient is
between 2 sizes. |
| Conductive Electrolyte
Gel | Conductive electrolyte
paste put in the central
hole of each electrode,
cleared in K860210
Elefix. | Conductive electrolyte
paste put in the central
hole of each electrode,
cleared in K860210
Elefix. | Conductive electrolyte
paste put in the central
hole of each electrode,
cleared in K860210
Elefix. |
| Type of Recorded
Signals and Channels | EEG, ECG, EMG, EOG
and breathing signals. - 29 unipolar
- 2 bipolar channels
The ground and the
reference are integrated
in the extender
connection. | EEG, ECG, EMG, EOG
and breathing signals. - 28 unipolar channels
for EEG including 4
channels for the
reference and the ground - 2 bipolar channels | EEG, ECG, EMG, EOG
and breathing signals. - 28 unipolar channels
for EEG including 4
channels for the
reference and the ground - 2 bipolar channels |
| Data Format | EDF | EDF | EDF |
| Sampling Rate | 250 or 500 Hz | 250 or 500 Hz | 250 or 500 Hz |
| Wireless Output | WiFi 2.4 GHz
WiFi 5 GHz
Bluetooth 2.4GHz - WiFi 2.412 GHz ~
2.484 GHz (2.4 GHz
ISM Band) - WiFi 5.180 GHz ~ 5.7 GHz | WiFi 2.4GHz
Bluetooth 2.4GHz - WiFi 2.412 GHz ~
2.484 GHz (2.4 GHz
ISM Band) - BLE 2.402 and 2.480 GHz | WiFi 2.4GHz
Bluetooth 2.4GHz - WiFi 2.412 GHz ~
2.484 GHz (2.4 GHz
ISM Band) - BLE 2.402 and 2.480 GHz |
| Device & Predicate
Device(s): | Subject Device
Neuronaute Plus
K231366 | Predicate Device
Neuronaute
K202334 | Reference Device
Neuronaute with
IceCap 2 & 2 Small
K223644 |
| | - BLE 2.402 and 2.480
GHz | | |
| Input dynamic range
and differential offset
voltage | ≤10% at ±150 mV | ±400mV | ±400mV |
| ADC Resolution | 24 bits | 24 bits | 24 bits |
| ADC Common Mode
Rejection Rate
(CMRR) | ≥-80dB at 50hz and
60Hz | > 105 dB | > 105 dB |
| Input Impedance | > 1Gohm | > 1Gohm | > 1Gohm |
| Input Noise | 24h | Neuronaute High
Capacity Battery
module: 199.5 x
170.6 x 27.2 mm
Autonomy : 24/72h | Neuronaute High
Capacity Battery
module: 199.5 x
170.6 x 27.2 mm
Autonomy : 24/72h |
| Weight | 49 g | Neuronaute High
Capacity Battery
module: 147 g | Neuronaute High
Capacity Battery
module: 147 g |
| Device & Predicate
Device(s): | Subject Device
Neuronaute Plus
K231366 | Predicate Device
Neuronaute
K202334 | Reference Device
Neuronaute with
IceCap 2 & 2 Small
K223644 |
| Accessories to connect
Neuronaute Plus to the
electrodes | Possibility of plugging 2
different extenders to
connect to: - IceCap and IceCap 2/ 2
Small via IceCap
Extender - Micromed EEG and
Cap electrodes via DB25
extender | Neuronaute BioAdapter | Neuronaute BioAdapter |
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Performance Testing
Non-Clinical and/or Clinical Tests Summary
Verification and validation
Electrical safety:
The electrical safety tests were performed by EMITECH for Neuronaute Plus according to :
- 60601-1:2005/AMD1:2012, 60601-1:2005, IEC 60601--IEC IEC 1:2005/AMD2:2020
- -IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 for use in conjunction with IEC 60601-1:2005, IEC 60601- 1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020
- IEC 80601-2-26:2019 for use in conjunction with IEC 60601-1:2005. -AMD1:2012, AMD2: 2020
All tests done for electrical safety tests are in passed status. We conclude that Neuronaute Plus appear to demonstrate substantially equivalent electrical safety to its predicate Neuronaute.
EMC tests:
The testing has been performed according to the following standard IEC 60601-1-2: 2014 + A1 (2020). According to the final report of the laboratory, the product fulfills the requirements of the standard like its predicate Neuronaute. All tests done by the laboratory are passed. The system used for EMC tests is substantially equivalent to Neuronaute system and demonstrates EMC substantial equivalence to the of Neuronaute Plus.
Wireless safety and likelihood of wireless coexistence:
These tests ensure radio-emission safety of Neuronaute Plus due to the implementation in its core module of WiFi (4G) and BLE modules like its predicate Neuronaute Head module. But additionally, those tests ensure the safety of Neuronaute Plus according to this main design change that consists of the WiFi 5G integration and the ability of the
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patient to wear Neuronaute Core Module by the patient within 20 centimeters of their body through the use of the Neuronaute Plus Holding Band.
All the tests on radio-emission safety are passed.
Therefore the adding of WiFi 5G module in the Neuronaute Plus core module do not appear to affect the safety or performance of Neuronaute Plus and remains substantially equivalent to Neuronaute.
Concerning the wireless functions (BLE and WiFi) of Neuronaute Plus, a safety risk analysis and likelihood of wireless coexistence tests allow us to conclude that Neuronaute Plus has demonstrated substantial equivalence to its predicate.
Programmable Electrical Medical System (PEMS):
The PEMS requirements have been implemented and tested for ensuring safety and electrical performance of Neuronaute Plus according to the IEC 60601-1:2005. IEC 60601-1:2005/AMD1:2012, IEC 60601- 1:2005/AMD2:2020 and IEC 62304:2007/A1: 2015 standard.
All tests addressing the electrical safety of the Neuronaute Plus firmware have been performed and are in PASSED status.
Because the firmware includes new features like data storage for more 24h, battery level checking, patient event button, etc. more tests have been performed to ensure its safety.
The difference in the number of tests between Neuronaute Plus and Neuronaute ensures an increased coverage of Firmware functionality safety compared to the predicate. Testing demonstrates substantial equivalence between the predicate and Neuronaute Plus.
Cybersecurity
According to the risk management file and cybersecurity FDA guidance, the design process allows to demonstrate the safety and the performance of the cybersecurity aspect for NEURONAUTE PLUS. To manage future unknown threats that would appear in all life cycle of NEURONAUTE PLUS, a cybersecurity post-market surveillance plan is implemented.
Biocompatibility
Based on the analysis of literature which covers raw materials. OEKO-TEX certificates that ensures the safety of used textiles taking into account manufacturing adjuvants, and the standard ISO 10993-1. no further testing is required for the evaluation of Neuronaute Plus biocompatibility. The risks associated with the product are considered very low in regard to its components, its use by the patient and the limited skin contact duration. Regarding the type and duration of skin contact, Neuronaute Plus and its accessories satisfy the requirements of ISO 10993-1 and FDA and can therefore be classified as a biocompatible device.
This confirms that Neuronaute Plus biocompatibility is substantially equivalent to the predicate Neuronaute even including the new accessory, the holding band. This confirms the substantial equivalence between Neuronaute Plus and its predicate.
Usability
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Human factors studies have been performed according to the IEC 62366-1 standard and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)" for Neuronaute Plus. The objective is to assess the usability within the overall human factors engineering process and to identify any potential risks related to the use of the Neuronaute Plus and prove that it is substantially equivalent to Neuronaute.
Usability tests were performed on two user groups:
- -User group 1: Health care professionals (Physicians, nurses, technicians) => n=9
- User group 2: Patients (15-30 years; 31-50 years; >50 years) => n=15 ।
Two configurations of the device system were tested: the entire Neuronaute Plus system associated with IceCap 2 electrodes and its corresponding extender, or the entire Neuronaute Plus with Micromed Cap electrodes associated with its DB25 extender.
The protocol was conducted in four main steps: a training, a study and session presentation (Oral information provided by the test personnel about the purpose of the evaluation), the usability tests, and a debriefing step.
The results of this evaluation have shown that the validation criteria are met with no use errors leading to critical or major risks that may lead to harm occurred during this evaluation, and the pre assessment of tested risks that did not result in new critical or major risks.
The usability testing conducted supports substantial equivalence of the Neuronaute Plus compared to its predicate.
Battery
The battery included in the Neuronaute Plus core module is compliant by design to the IEC 62133 ed. 2.
In addition to this compliance, electrical safety tests on the system itself (including the battery and, for specific requirements, on the battery alone on its charger) were performed for Neuronaute Plus according to:
- -IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020
- IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 -
- -IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 for use in conjunction with IEC 60601-1:2005, IEC 60601- 1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020
All tests done for electrical safety tests on battery are in "passed" status.
We conclude that Neuronaute Plus appears to demonstrate substantially equivalent electrical safety to its predicate, Neuronaute.
Clinical tests
No clinical data was needed for demonstrating substantial equivalence of the Neuronaute Plus.
Conclusion
All main concerns of new risks following the development of Neuronaute Plus compared to Neuronaute and Neuronaute with IceCap 2 & 2 Small was assessed in this
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document. According to these results described above, we have demonstrated substantial equivalence of Neuronaute Plus with its predicate.