(209 days)
The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.
The Flexset System is intended to acquire, transmit, display and store primarily EEG and optionally auxiliary signals. Specific transport environments in the Indications for Use include ambulances, cars, buses, trains, boats and via air, per stipulation in the user manual of the device. The Flexset headset is designed to record a full montage EEG, with optional external references and additionally up to 8 auxiliary channels using lead wires for EEG, EOG, ECG or EMG. The device consists of the following components:
The provided 510(k) summary for the Zeto, Inc. Flexset System does not contain the specific details about the acceptance criteria or a dedicated study proving the device meets those criteria in the way typically expected for an AI/ML-driven diagnostic device.
This document describes a device for acquiring, transmitting, displaying, and storing EEG and auxiliary signals. It focuses on demonstrating substantial equivalence to a predicate device (WR19 System) and a secondary predicate device (X-Series System) based on technological characteristics and intended use. The performance data section refers to compliance with general medical device standards (e.g., IEC 80601-2-26:2019 for EEG performance) rather than specific acceptance criteria for diagnostic performance outcomes.
Therefore, many of the requested items cannot be extracted directly from this document. However, I can infer some information based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from standards compliance) | Reported Device Performance (From Section 3.3.3 EEG Measurements, 3.3.4 ECG Measurements, 3.3.8 Non-ECG auxiliary measurements) |
|---|---|
| EEG Measurements (IEC 80601-2-26:2019 compliance implies meeting certain performance specs) | |
| Sampling Rate | 500 Hz |
| Dynamic Range | ± 375 mV |
| Resolution | 44.7 nV |
| Peak-to-peak noise | 4 µV |
| Common-mode rejection ratio | > 120 dB |
| Input impedance | 1 TΩ |
| Noise | 1 µV RMS |
| A/D Conversion | 24 Bit |
| ECG Measurements (Compliance implies meeting certain performance specs) | |
| Sampling rate | 500 Hz |
| Dynamic range | +/- 3900 mV |
| Resolution | 0.536 µV |
| Peak to peak noise | 4 µV |
| Common Mode Rejection Ratio | > 110 dB |
| Input Impedance | >1 TΩ |
| A/D Conversion | 24 Bit |
| Non-ECG Auxiliary Measurements (EOG/EMG) (Compliance implies meeting certain performance specs) | |
| Sampling rate | 500 Hz |
| Dynamic range | ± 375 mV |
| Resolution | 44.7 nV |
| Peak-to-peak noise | 4 µV |
| Electrical Safety (IEC 60601-1:2005+AMD1:2012+AMD2:2020) | Compliant |
| Electromagnetic Compatibility (IEC 60601-1-2:2014+AMD1:2020) | Compliant |
| Biocompatibility (ISO 10993-x series) | No evidence of toxic potential or adverse reactions |
Limitations: The document does not specify quantitative acceptance criteria (e.g., "EEG noise must be
§ 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).