Would the use of a non-significant device used as an intervention outside it’s approved treatment vs. standard of care considered ACT?

Unfortunately, I do not have a background in the determination of significant risk/non-significant risk devices, but according to language from the Elaborations of Responsible Party and Applicable Clinical Trial document:

“…a non‐significant risk device considered to have an approved IDE in accordance with 21 CFR § 812.2(b)… would be an applicable device trial if it meets the other qualifications of applicable device trial.”