Ann: Trading Halt, page-34

The Oscar 2 device is used in clinical settings, and was the primary predicate device.
I'm thinking we should have been able to prove Pulse was the equivalent to Oscar 2, and as such, can be used in the same way ( ie. clinical supervision ).
I'm guessing to take Pulse to the next level will require full FDA acceptance with PMA standard, more rigorous consumer testing, trials etc.

A reminder of what is required to achieve 510K clearance

If a company can prove its device is “substantially equivalent” to another already on the market, it can forego clinical trials and testing, saving time and money. Unlike the more rigorous PMA standard, which is to reasonably ensure safety and effectiveness, the 510(k) standard is to determine whether a device is substantially equivalent to a legally marketed device.

In other words, when the FDA clears a device through 510(k), it is not examining if the product is safe or effective for use in patients. It is just agreeing with the maker’s claim that the device is similar to another device already on the market.

FACT

FDA clearance through the 510(k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously approved product.

In making that determination, the FDA will conclude a device is substantially equivalent to a marketed device if:

It has the same intended use as the predicate device and the same technological characteristics.

Or it has the same intended use as the predicate device, has different technological characteristics, does not raise new questions of safety and effectiveness and the applicant can show that the device is at least as safe and effective as the marketed device.

The law allows the FDA to require study data from a 510(k) applicant, but the agency rarely takes that step.