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510(k) Data Aggregation
(179 days)
IASIS i2 Relaxation Neurofeedback System is a neurofeedback device intended for relaxation and stress reduction through the use of EEG biofeedback.
IASIS i2 Relaxation Neurofeedback System is a medical device system prescribed for providing relaxation and stress reduction biofeedback treatment. It consists of a multi‐channel EEG recording device and the software running on a Windows laptop.
The IASIS i2 Relaxation Neurofeedback System includes an EEG recording device encased in a plastic enclosure. It is connected to the laptop with a standard USB‐A to USB‐C cable capable of drawing at least 3 Amps of power. The device is powered by the laptop through the USB cable. The device has 9 standard, electrically safe DIN 42802 single‐pin input connectors. Pre‐existing EEG lead wires with integrated Ag/AgCl EEG electrodes made by Rhythmlink International, LLC (K061148), and Elefix V Paste for EEG & EMG made by Nihon Kohden Corporation (K191975) are connected to the input connectors of the device. The device does not have any user controls; it is turned on and off by the IASIS i2 Relaxation Neurofeedback System software through the USB connection. The device has a single indicator of operation – a cyclic pattern illumination is applied to the translucent plastic logo and a plastic rim around the bottom of the device when it is turned on.
The device has at least 2 input raw EEG channels with 24‐bit A/D resolution. This enables it to deliver more than 12 significant bits of EEG signals without the need for heavy analog filters, which significantly distort the raw EEG signals. It samples all input channels at least at a 250 Hz sampling rate.
The device provides an industry‐standard level of electrical safety against up to 5000V of electric shock from the power line. It also provides ESD protection of input channels for up to 15,000V.
The IASIS i2 Relaxation Neurofeedback System software is a desktop application installed and run on a laptop under Windows 10 or newer. The software operates in two modes: Cloud or Local. When it operates in Cloud mode, clinicians utilize the IASIS Cloud Portal – a web application running on the cloud server providing comprehensive patient management functions. To run a new biofeedback session, the clinician logs into the portal, selects a patient from the patient directory, and launches a new session. The web application launches the IASIS i2 Relaxation Neurofeedback System software on the laptop to start a new session.
The IASIS i2 Relaxation Neurofeedback System is designed to be Internet‐independent in the case of absence or poor Internet connection by operating in the local mode. If the clinician switches to the local mode, the software uses the local data storage, which automatically synchronizes with the Cloud storage when an Internet connection becomes available.
When a new biofeedback session is started, the clinician uses an intuitive graphical user interface to set all parameters needed for the session: selecting EEG topical sites where the EEG electrodes will be placed and selecting the type of biofeedback protocol. It also prompts the clinician to measure the impedance of all assigned EEG electrodes, checks raw EEG signals, and begins a new biofeedback session.
The electrode impedance is measured every time the electrode placement is conducted or changed. The duration of standard neurofeedback protocols is short, which does not lead to noticeable deterioration of the electric contact between electrodes and skin after proper placement and impedance measurement. Therefore, continuous real‐time electrode impedance measurement is not required.
During the session, the IASIS i2 Relaxation Neurofeedback System software displays raw EEG signals to control the quality of input data, their real‐time spectral images, and all standard brainwave amplitudes. It also displays the current threshold of the target EEG band according to the selected training protocol. When the selected EEG band hits the threshold level, the system may provide visual or auditory feedback.
Once the training session is completed, the software shows a session preview with the target EEG brainwaves recorded during the session. The clinician saves the results of the session in the local data storage, and the system automatically synchronizes the data to the cloud storage when an Internet connection is available.
The IASIS i2 Relaxation Neurofeedback System provides maximum security for the recorded information, including available patient health information, by storing all data in the local or cloud storage in an encrypted format and transmitting the information over the Internet using a secure data transmission protocol.
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(343 days)
The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients.
It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment.
The Neuronaute requires operation by a trained healthcare professional.
The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
The Neuronaute is a wearable and wireless equipment, which allows acquisition, recording, storage, transmission and displaying of electroencephalogram (EEG).
The Neuronaute is composed of a textile cap where twenty-one titanium dry electrodes are attached. An electronic box is attached to the cap (EEG recording) associated to batteries. The system operates on battery power only.
The system is connected to a device (i.e. smart phone or a digital tablet) loaded with a separate stand-alone software program ("app"). The app works with a cloud backend service, which allows the user management and authentication, the data storage for application recordings and access to this data via a web-based interface, the devices management and authentication, the recording scheduling, the download of the latest firmware version.
The acquired signals are saved in a universal data format (European Data Format, EDF) that is intended to be visualized by a Physician through the web-based interface.
Here's an analysis of the acceptance criteria and supporting study for the Neuronaute device, based on the provided FDA 510(k) summary:
The Neuronaute device is an electroencephalograph (EEG) system intended for acquiring, recording, storing, transmitting, and displaying EEG from adult patients. The acceptance criteria and supporting studies focus on demonstrating that the Neuronaute performs similarly to or better than predicate devices, and meets relevant electrical, software, and biocompatibility standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets and then "reported device performance" in a separate section. Instead, the "Performance Data" and "Technological Characteristics" sections describe testing conducted and the device's measured specifications, often compared directly to predicate devices to demonstrate substantial equivalence. I will synthesize the relevant information into a table, focusing on direct and inferable criteria for signal quality and electrical characteristics.
| Acceptance Criteria (Inferred from Predicate Equivalence & Standards) | Neuronaute Reported Performance |
|---|---|
| Electrical Performance: | |
| Sampling rate | 500 s/s (vs. predicate 256 s/s) |
| Dynamic range | +/- 600mV (vs. predicate +/- 1000 µV - note: units differ, but generally implies a range adequate for EEG) |
| Noise | < 6 µVpp (vs. predicate 3.7 µV typical - comparable or slightly higher, within acceptable range for EEG) |
| CMRR (Common Mode Rejection Ratio) | 115dB (vs. predicate 110dB - better) |
| Input Impedance | 1 Gohm (vs. predicate 100 Gohm - lower, but still high enough for good signal acquisition) |
| Hardware filtering | 125Hz lowpass (vs. predicate 100 Hz Low Pass) |
| Biocompatibility | Compliance with ISO 10993: Cytotoxicity, Irritation, Sensitization testing shown to be substantially equivalent to predicate. Materials (Ti6A14V ELI & OEKO-TEX® yarns) chosen for known biocompatibility. |
| Electromagnetic compatibility (EMC) & Electrical safety | Compliance with IEC 60601-2-26:2002 and FDA Guidance demonstrated, substantially equivalent to primary predicate. |
| Software Validation | Verification and validation according to IEC 62304:2006 and FDA Guidance "General Principles for Software Validation". Results demonstrated meeting requirements for safety, function, and intended use. |
| Signal Quality: | |
| Acceptability of signal quality against gold standard | Testing performed shows similar electrical and signal performance as the Rythmlink Disc Electrodes (K061148, considered gold standard). |
| Alpha Rhythm presence | Physiological tests showed normal presence of alpha modulation in eyes opening/closing task. |
| Impedance levels | Most impedances were below 1 MOhm. |
| Data loss | Chirp and Ramp tests presented no data lost with the current version of software. |
2. Sample Size Used for the Test Set and Data Provenance:
- Physiological Tests (Impedance, Alpha Rhythm):
- Impedance tests: 24 subjects.
- Alpha Rhythm tests: 26 healthy adult subjects.
- EEG signal testing for comparison with Rythmlink Disc Electrodes: The document doesn't explicitly state the number of subjects for this comparison, but it implies a test was conducted.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the mention of "healthy adult subjects," it implies a prospective clinical or research study was conducted internally or with a clinical partner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not describe the use of experts to establish ground truth for the physiological or comparative EEG signal quality tests. The "gold standard" comparison for EEG signal quality refers to a predicate device (Rythmlink Disc Electrodes), not expert interpretation of data. The physiological tests (Alpha Rhythm, Impedance) likely relied on objective measurements and established physiological markers rather than expert consensus for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no expert-based ground truth establishment or adjudication process is described for the tests mentioned. The assessment of signal quality and electrical performance appears to be based on direct measurement and comparison to predefined technical specifications and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The Neuronaute is described as a device that only acquires and displays physiological signals, with "no claims being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This means the device does not provide AI-assisted interpretations to be compared against human readers. Its function is data acquisition and display.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone algorithm performance study was not done, as the Neuronaute explicitly states it makes "no claims ... for analysis of the acquired signals." The "software" (firmware, mobile app, cloud) focuses on verification and validation of its functionality in acquiring, recording, storing, transmitting, and displaying data reliably and safely.
7. Type of Ground Truth Used:
- For EEG signal quality comparison: The "gold standard" was another cleared EEG electrode, Rythmlink Disc Electrodes (K061148). This serves as a technical ground truth for comparison of electrical and signal performance.
- For physiological tests (Alpha Rhythm, Impedance): The ground truth is based on established physiological phenomena (e.g., normal presence of alpha modulation, expected impedance levels) and objective measurements.
8. Sample Size for the Training Set:
The document does not mention any "training set" as it is not an AI/ML device that performs analysis or interpretation. The software validation is for the functionality of data handling and display, not for learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
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