US FDA Approval, page-6

As it is a class I medical device you still need relevant data. However, the FDA is likely to not request additional data for a class I. A class II or III, the FDA will most likely prefer or request additional data and that the study requested be run within the US. Usually companies that arnt to naive to the process will hire a consultant to figure out whether additional studies or data are required. Even before submitting the FDA will usually let you know of you are missing stuff.

I would say we should be alright at this stage, but the FDA is fickle about international products compared to homegrown ones. A curveball might enter.