The Irregular Rhythm Notification Feature
The Irregular Rhythm Notification Feature (IRNF) 2.0 is a comprehensive system consisting of two primary component apps: one on the Apple Watch and another on the iPhone. The IRNF is a software-only mobile medical application intended for use with the Apple Watch. Its primary purpose is to analyze pulse rate data using Apple Watch models’ photoplethysmography (PPG) sensor for identifying episodes of irregular heart rhythms that suggest atrial fibrillation (AFib) and subsequently issue notifications to the user.
IRNF 2.0 operates as a background screening tool. Integrating this feature with the iPhone’s Health App, a standard application on all iPhones, allows users to effectively store, manage, and share their health and fitness data. In addition to its notification capabilities, the IRNF 2.0 iPhone App plays a crucial role in user education and history tracking. Before enabling atrial fibrillation (AFib) notifications, users must engage with onboarding and educational materials available in the app.
Designed for over-the-counter (OTC) use, the IRNF is not meant to catch every instance of irregular rhythm indicative ofatrial fibrillation (AFib), nor does a lack of notification imply the absence of a disease process. Instead, it opportunistically notifies the user of potential atrial fibrillation (AFib) when sufficient data is available, which is typically gathered when the user is stationary. It’s important to note that the IRNF is not intended to replace traditional diagnostic or treatment methods and is not tested for use in individuals under 22 years old or those who have already been diagnosed with atrial fibrillation (AFib).
Reference
Irregular Rhythm Notification Feature (IRNF) 510(k) Premarket Notification.” n.d. Accessed December 4, 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231173
You must be logged in to post a comment.