Masimo W1 is a wearable watch device that continuously records, displays, and transfers single-channel ECG rhythms and pulse oximetry parameters. It includes software for automated classification of atrial fibrillation to aid in heart rhythm identification, designed for adults in clinical and home settings to support healthcare professionals and patients in monitoring heart conditions.
Masimo W1 and the integrated Masimo W1 Module are intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The device detects the presence of atrial fibrillation and supports classification of either atrial fibrillation (AFib) or sinus rhythm for informational use only in adults 22 years and older. It is also intended for spot-checking of functional oxygen saturation (SpO2) and pulse rate (PR) in adults in hospitals, clinics, long-term care facilities, and homes.
Masimo W1 uses an integrated module combining electrical sensing for ECG and optical sensing (Masimo SET pulse oximetry) for SpO2 and pulse rate. ECG signals are detected via electrical contacts on the wrist and fingers and processed by software that analyzes rhythms, including atrial fibrillation detection based on pattern irregularity. The device communicates data wirelessly to compatible smart devices for display and tracking.
Performance evaluation includes clinical validation of the AFib classification feature showing 99.3% sensitivity and 100% specificity. The ECG waveform quality was validated against 12-lead ECG references with 98% clinician agreement. Bench, software verification, human factors, and cybersecurity testing support substantial equivalence and safety. No hardware changes were made from previous clearance.
No predicate devices specified
Submission
10/21/2024
FDA Approval
4/3/2025
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