(37 days)
Neuronaute with IceCap 2 & IceCap 2 Small 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 and pediatrics. 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.
Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array. The system includes the Neuronaute Head Module, IceCap 2 & IceCap 2 Small electrodes, battery, Bioadapter with the IceAdapter, mobile app, and the Neuronaute N-CLOUD. The IceCap 2 and IceCap 2 Small are single-piece flexible printed circuit headsets with 21 EEG sensors (19 EEG channels, 1 reference and 1 ground), 4 skin adhesive areas and 2 connectors. The electrodes are made of Ag/AgCl sensors connected via conductive silver ink and insulated with dielectric ink. The system allows remote access by users via the Neuronaute N-CLOUD. An optional video system composed by N-way and N-Deo is available.
The provided text describes the Neuronaute with IceCap 2 & IceCap 2 Small system, an electroencephalograph device. However, it does not contain a detailed study proving the device meets specific acceptance criteria for diagnostic performance. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neuronaute, K202334) through a comparison of technical characteristics and non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or report such performance for the Neuronaute with IceCap 2 & IceCap 2 Small. The comparison table focuses on technical specifications and material changes relative to the predicate device.
| Acceptance Criterion (Implicitly compared to predicate) | Reported Device Performance (Relative to Predicate) |
|---|---|
| Ability to acquire, display, store, archive, and periodically transmit EEG signals | Equivalent: "The function of the system and the connection of the different elements remain the same." |
| Target population (Adults and Pediatrics 5 years and older) | Expanded: Subject device includes pediatric patients (5 years and older) due to two sizes of IceCap 2. Predicate was adults (18+). |
| Electrode material (Ag/AgCl) | Improved: Subject device uses Ag/AgCl for longer recording (up to 72h) compared to predicate's copper covered with silver (12.5h limitation due to copper migration). |
| Biocompatibility | Equivalent: "IceCap 2 / 2 Small electrodes material has been assessed by consensus standard for biocompatibility testing, as previously done with its predicate Neuronaute." |
| Electrical safety | Equivalent: Nonclinical tests demonstrated "safe" performance. |
| Performance (General) | Equivalent: Nonclinical tests demonstrated "as effective, and performs as well as the legally marketed predicate device." |
| Number of electrodes (19 EEG, 1 reference, 1 ground) | Equivalent: "Up to 21 electrodes" with the same distribution. |
| Montage (10/20 System) | Equivalent: Both use 10/20 System. |
| Head size accommodation | Improved: Subject device offers two sizes to accommodate head circumferences from 43 to 60 cm (including pediatric). Predicate had one size for "at least 90% of the population." |
| Conductive electrolyte paste | Equivalent: Both use "Elefix" paste. |
| EEG channels (Up to 24) | Equivalent: Both have up to 24 channels. |
| Data format (EDF) | Equivalent: Both use EDF. |
| Sampling Rate (250 or 500 Hz) | Equivalent: Both support 250 or 500 Hz. |
| Wireless Output (WiFi 2.4GHz, Bluetooth 2.4GHz) | Equivalent: Same wireless specifications. |
| Input dynamic range and differential offset voltage (±400mV) | Equivalent: Same specifications. |
| ADC Resolution (24 bits) | Equivalent: Same specifications. |
| ADC Common Mode Rejection Rate (CMRR) (> 105 dB) | Equivalent: Same specifications. |
| Input Impedance (> 1 Gohm) | Equivalent: Same specifications. |
| Input noise ( |
§ 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).