Ann: Positive Results for Australian Prospective Paediatric Study, page-131

Its NOT classified as anything until it has been submitted to a regulator for examination, so stopped jumping the gun.
Scenarios Under Which a Device Manufacturer Can Obtain a De Novo Classification

There are two scenarios under which a device manufacturer can obtain a de novo classification. In both cases, the company must ask the Food and Drug Administration to evaluate whether the device is a class I or II device on the basis of its risks.
Under the first scenario, the device manufacturer submits a pre-submission to the Food and Drug Administration. The Food and Drug Administration then provides feedback on whether the de novo process is appropriate. If the de novo mechanism is appropriate, the Food and Drug Administration provides information on the documentation necessary to submit a de novo application.
Approval of a device via this scenario depends on whether the device manufacturer has conducted an effective search for an equivalent currently-marketed device, determined the risks and identified mechanisms to decrease such risks, and collected enough data for the Food and Drug Administration to determine its safety and efficacy.
Under the second scenario, a company can obtain a de novo classification by requesting it within thirty days after the Food and Drug Administration has determined that the device is not substantially equivalent. If there is no substantially equivalent device upon which to make a determination, the sponsor can ask the Food and Drug Administration to determine whether the mechanism is appropriate without submitting a 510(k) application.