Proposed predicate device refers to a lawfully marketed, 510(k) cleared product that is used to determine substantial equivalence of the proposed/new device for 510(k) Submission.
Yes, FDA submission is required because the 510(k) clearance is determined by the proposed device’s substantial equivalence to a legally marketed device. A comparison table and discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalence is an important aspect of the 510(k).