Apple made a number of high profile announcements yesterday regarding their new iPhone releases, but of particular interest to the medical device world was the Apple Watch Series 4 product announcement by the Verge on the incorporation of an EKG scanner in the new Apple Watch. This marks the first entry of Apple into FDA regulated medical devices with not one but two medical devices using the Apple Watch as the backbone delivery mechanism.
Both FDA regulated medical devices by Apple were cleared by the FDA by what is called the de novo classification request pathway. The de novo pathway allows for a medical device that is so new to FDA and without a FDA identifiable primary predicate needed to adhere to the standard 510(k) clearance pathway, to be deemed by the FDA to represent a moderate risk device such that it could be deemed a class II device by FDA risk definitions, and thus enter the market on its own merits and not be subject to the more rigorous, costly and time consuming FDA class III Premarket Approval (PMA) process.
Their first de novo is called the Apple ECG App and was classified by the FDA as Electrocardiograph Software for Over-The-Counter Use (OTC). This is important because devices are classified by the FDA as either a prescription use device (requiring a physician or medical professional to prescribe their use to a patient or customer) or Over-the-Counter Use (a patient or customer can purchase the product at will). This OTC designation allows customers to start using the Apple ECG App without a prescription by downloading the app to their Apple Watch Series 4. The indications for use for this ECG App has some limitations with respect to the type of patients it could be used with as described in their de novo classification request as being used for the following:
The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old.
Despite some of these limitations, such as not recommended for users with known arrhythmias, actions shouldn’t be taken based on ECG App alone without healthcare professional consultation, and that it is meant to supplement existing methods and not intended to replace traditional methods of diagnosis and treatment, this is a watershed moment for Apple and the medical device space in general, because now for the first time Apple Watch Series 4 customers can with an Apple product alone gather information that is FDA regulated and supply to their healthcare professionals as needed.
The second de novo is called the Apple Irregular Rhythm Notification Feature and was classified by the FDA as Photoplethysmograph Analysis Software For Over-The-Counter Use. As noted above, this carries the benefits of an OTC device to customer utilization. As noted with the ECG App, the indications for use for this Irregular Rhythm Notification Feature has some limitations with respect to the type of patients it could be used with as described in their de novo classification request as being used for the following:
The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment. The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.
There are limitations to tease through on the indications for use language, but the most notable one is that it isn’t intended for a user in motion by the statement “these data are only captured when the user is still“. Despite this, when looking at the ECG App and the Irregular Rhythm Notification Feature used in combination, it presents an opportunity to identify ECG rhythms that may be suggestive of something that deserves a closer look by healthcare professionals, such as Atrial Fibrillation (or AFib). The statement that this can be used along with user’s risk factors to supplement for AFib screening is a powerful element to the population of Apple Watch Series 4 customers. It cannot be understated the impacts of having this kind of ECG waveform data captured on a regular basis over many hours and supplied to healthcare providers, versus having ECG data only captured at a singular medical facility visit, which represents a snapshot in time look.
It is worth noting that any de novos that enter the market create an opportunity for other companies to use as a basis of a primary predicate for a standard 510(k) clearance submission. Companies active currently in the medical device space, or those looking to gain entry for the first time, are likely cheering for all of the hard and novel work Apple has performed in receiving these de novos. It is highly probable in the future that Google, Fitbit and other participants eyeing the FDA regulated medical device space, depending on their technological developments and FDA regulatory efforts, will seek to gain entry as regulated medical devices as FDA 510(k) cleared devices using these Apple de novos as a precedent.
