Is Flow2 a medical device, and how should it be described in a research submission to an IRB?

Flow2 is not considered to be a medical device. Flow2 is intended for research purposes and can be used under your institution's IRB or as a consumer electronic device. Please refer to the sample language below for describing Flow2 in a research submission to an IRB. See the Flow2 Spec sheet on Kernel’s Products page if you need to include more technical details for your research purposes.

Flow2, TD-fNIRS System

This neurotechnology product, the size and the look of a bicycle helmet, detects cortical blood oxygenation changes using a compact and modularized realization of TD-NIRS. Data results are for research purposes and are considered informational only with no clinical significance.

NIRS is a spectroscopic method used to measure cerebral oxygenations by applying light to the head, which then scatters throughout the brain and is detected upon exiting the head. Changes in the detected light intensity allow inference of optical-property changes inside the head, such as hemodynamics. 

In contrast to other types of NIRS, Flow's time-domain system captures a richer signal by applying light in short pulses and precisely capturing the arrival time distribution of scattered photons for each pulse. On average, photons that arrive at the detector later traveled deeper through the tissue. Therefore, this "time-of-flight" (ToF) measurement in addition to the overall intensity reveals additional depth-dependent information about the optical properties of the tissue.

In addition, EEG electrodes can be incorporated into the Flow headset, which measures electrical activity on the scalp. This will contribute to a comprehensive analysis of brain activation with high temporal resolution of neural activity that ties to the hemodynamic components.

Kernel complies with 21 CFR 1040.10 laser product labeling requirements for Flow. Refer to the instructions for use at https://docs.kernel.com.