(303 days)
The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, and 1 direct current channel.
The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.
The Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (Subject device) is an ambulatory wireless digital neurophysiological device capable of recording, processing, and displaying electroencephalography (EEG), video EEG, long-term monitoring (LTM), and polysomnography (PSG) biopotential signals.
As listed in Table 1, The NS-AM device comprises an Electronic Unit, a Battery Adaptor, an External Rechargeable Battery Bank, a Carrying Pouch and the Neuron-Spectrum.NET desktop application software. The Neuron-Spectrum.NET Software application was cleared in the Predicate's 510(k) submission (K133995).
The Subject device supports up to 21 EEG channels, 4 wide-band polygraphic channels, 1 breath channel, and 1 direct current channel for a total of 27 analog input channels.
The Electronic Unit acquires, records and transmits biopotential signals such electroencephalography (EEG) and polysomnography (PSG). The built-in 2.4GHz Wi-Fi radio allows real-time transfer of the collected biopotential signals to the computer running the Neuron-Spectrum.NET software. The biopotential signals are also recorded onto a removable SD memory card as back up for later post analysis.
The Electronic Unit includes a front panel ON/OFF power button, a light sensor and a User Interface (UI). The UI consist of a liquid crystal display and three menu navigation buttons. Figure 4 shows the UI main functions. The Electronic Unit can be powered by replaceable internal AA batteries or by the External Rechargeable Battery Bank.
The Electronic Unit and the External Rechargeable Battery Bank reside side-by-side inside the Carrying Pouch. The pouch is strapped and worn over the patient clothing while in use.
The Neuron-Spectrum.NET software is a computer application that receives, records, processes, and displays the biopotential signals collected by the electronic unit on the PC display. The main operations provided by the Neuron-Spectrum.NET software are:
- EEG Acquisition
- · EEG Review, Editing, Storing, Exporting.
- EEG Analysis
- Creation of Exam Reports
- · Program Setup
The electronic unit measures (141 H x 96 W x 36 D) mm and weighs about 270 grams. The External Rechargeable Battery Bank unit measures (165 H x 106 W x 25 D) mm and weighs about 570 grams. The combined weight for the electronic unit, the battery adaptor and the External Rechargeable Battery Bank is approximately 880 grams.
The provided FDA 510(k) summary (K220254) for the Neurosoft Ltd. Neuron-Spectrum-AM with Neuron-Spectrum.NET Software describes the device and its claimed substantial equivalence to a predicate device (K133995). Given the information, here's a breakdown of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "sensitivity must be > X%") for the device's diagnostic performance, nor does it report specific performance metrics like sensitivity, specificity, accuracy, etc., for the device's clinical efficacy.
Instead, the acceptance criteria are implicitly met through demonstrating substantial equivalence to a predicate device by showing that it "is as safe, as effective, and performs as well as or better than the Neuron-Spectrum-4/P with Neuron-Spectrum.NET Predicate device".
The "reported device performance" is focused on passing various non-clinical engineering and software tests to demonstrate this substantial equivalence.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Device Safety & Effectiveness (Overall) | "The documentation and test results provided... demonstrate that the Neuron-Spectrum-AM with Neuron-Spectrum.NET Software device is as safe, as effective, and performs as well as or better than the Neuron-Spectrum-4/P with Neuron-Spectrum.NET Predicate device." |
| Biocompatibility | All patient-contacting materials (Housing, External Rechargeable Battery Bank, Carrying Pouch) were found to be Biocompatible. |
| Electrical Safety | Passed and complies with applicable standards (e.g., IEC 60601-1, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-11). |
| Electromagnetic Compatibility (EMC) | Passed and complies with applicable standards (e.g., IEC 60601-1-2). |
| Wireless Coexistence & RFID Immunity | Passed these tests, ensuring proper functioning in environments with other wireless devices. |
| Bench Testing (Signal acquisition quality compared to predicate) | The summary states that "bench testing concluded that the Subject device meets and complies with the ... bench testing requirements." While specific metrics are not explicitly stated as acceptance criteria, the comparison table implicitly indicates that they were found to be similar or equivalent to the predicate for critical parameters: |
- Input noise EEG: Within 0.5-200 Hz not more than 2 µV (not more than 0.3 µV)
- Input impedance EEG: Not less than 400 MΩ
- CMRR: Not less than 100 dB
- 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).