(330 days)
The Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) is indicated as follows:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The device includes the Atrial Fibrillation Detection Feature analyzes pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of atrial fibrillation (AFib) and provides a notification on the display screen to the user. This feature is intended to be used for home screening for the possibility of AFib.
The Atrial Fibrillation Detection Feature is not intended to provide a notification on every episode of AFib and the absence of detection is not intended to indicate the absence of atrial fibrillation. The feature is not intended to replace traditional methods of diagnosis or treatment or to be used in the management of patients with known AFib.
The device is intended for over-the-counter (OTC) use in the home environment. The device is intended for use in adults (22 years or older); it has not been tested for and is not intended for use in pregnant women or people with implanted pacemakers or defibrillators.
The Omron Blood Pressure Monitor with AFib Detection Feature is an OTC, at home use, upper arm blood pressure monitor. The device consists of a monitor and an arm cuff designed to be used on the upper arm. It is battery powered and can optionally be connected to an AC adapter. The proposed device measures blood pressure (systolic [SYS] and diastolic [DIA]) and pulse rate (PR), detects the presence of irregular heartbeats, and can also detect the possible presence of AFib by analyzing pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of AFib and provides a notification on the display screen to the user.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (OMRON BP Monitor with HEM-FL31 cuff) | Reported Device Performance (OMRON BP Monitor with HEM-RML31 cuff) |
|---|---|---|
| Sensitivity statistically significant to 85% | 0.9509 (95% CI: 0.9249 - 0.9769), p-value |
N/A