(115 days)
No
The summary explicitly states "Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition." and there is no mention of AI, ML, or related concepts in the device description or performance studies.
No
The device is intended to acquire, display, store, archive, and transmit EEG signals to assist in the diagnosis of neurological disorders. It does not provide any treatment or therapy.
Yes
The device is intended to assist in the diagnosis of neurological disorders by acquiring and displaying EEG signals for physician review.
No
The device description explicitly lists multiple hardware components (Neuronaute Head Module, High Capacity Battery Module, BioAdapter, IceCap) in addition to the software components.
Based on the provided information, the Neuronaute device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use of Neuronaute is to acquire, display, store, archive, and transmit EEG signals from the brain. This is a measurement of electrical activity within the body, not an analysis of a sample taken from the body (like blood, urine, tissue, etc.).
- The device description and intended use focus on signal acquisition and display. While the system is intended to assist in the diagnosis of neurological disorders, it does so by providing EEG data for review by a medical professional. It explicitly states that it "do[es] not provide any diagnostics conclusions or automated alerts."
- The performance studies focus on device functionality and signal quality. The non-clinical testing includes electromagnetic compatibility, electrical safety, EEG signal quality, software validation, and usability. These are typical tests for medical devices that measure physiological signals, not for devices that analyze biological samples.
In summary, Neuronaute is a medical device that measures and transmits physiological signals (EEG) from the brain to aid in diagnosis, but it does not perform analysis on samples taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWO, GXY
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
Adults (ages 18 and above)
Intended User / Care Setting
Trained medical professionals for patients under medical supervision. Physician's office, hospital, or other remote locations.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Testing:
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 AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2007, IEC 60601-1-11 Edition 2.0 2015-01, and IEC 60601-2-26:2012.
BioSerenity compared the Neuronaute device with EEG gold standards to demonstrate signal quality.
Firmware in Neuronaute Head Module, mobile application, and Cloud have been tested through verification and validation procedures according to IEC 62304: 2006/A1:2016 and FDA Guidance "General Principles for Software Validation". Results demonstrate software meets requirements for safety, functional, and intended use.
Usability tests were conducted according to IEC 62366 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)" to assess usability and identify potential risks.
Key results: The tests 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K072016, K860210, K080546, K011204, K170441, K010460
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
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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.
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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.
| 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 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 | $