FDA Regulation

Both our mobile application and mechanical device will likely be a combined Class 2 medical device because it is non-invasive and is not life sustaining, but rather an addition to the oxygen concentrator to improve the current system for increased efficacy and ease of use for patients. The oxygen concentrators we will be building our mechanical device and mobile application for are Class 2 devices as well. There is not a high risk associated with our product apart from malfunction which may leave the patient unaware of what the oxygen liter flow is when they rely on the equipment and do not physically adjust the flow on their own. The application will be similar to other FDA approved mobile applications. Though there are wireless remote control oxygen concentrators, no one has created a wireless control of standard in home oxygen concentrators that has a knob to adjust oxygen liter flow using a mobile application while also obtaining oxygen saturation information as a  parameter for adjustments. For this reason, even though our device is a Class 2 device, a 510(k) won’t be applicable. A 513(g) will have to be filed to go down the de novo route rather than a PMA due to the low risk associated with the device. There is a lot of uncertainty regarding FDA approval for mobile medical apps. The FDA encourages manufacturers of  mobile medical apps that perform patient-specific analysis to contact FDA to discuss what, if any, regulatory requirements may apply to their mobile. Based on the FDA’s guidance for mobile health applications since our mobile medical apps will control the oxygen liter flow, it is considered an accessory to the connected device (oxygen concentration) and is required to comply with the controls applicable to that connected device.in order to address any associated risks. As of right now general controls will be followed as well as special controls of the oxygen concentrations themselves in conjunction with our device and whatever else the FDA deems appropriate.