(330 days)
Not Found
Not Found
No
The document describes the device's AFib detection feature as analyzing "pulse pressure wave data" and does not mention AI, ML, or any related terms in the description of the technology used for this analysis. The performance study focuses on traditional metrics like sensitivity and specificity, without mentioning AI/ML-specific evaluation methods.
No
The device is a digital monitor intended for measuring blood pressure and pulse rate, and for detecting the appearance of irregular heartbeats and possible AFib. While it provides health information, it is not intended to provide diagnosis or treatment, which are the hallmarks of a therapeutic device.
Yes
The device detects irregular heartbeats and identifies episodes of atrial fibrillation (AFib) by analyzing pulse pressure wave data, providing a notification to the user, and performance metrics like sensitivity and specificity are provided for AFib detection. Although it states it's not intended to replace traditional methods of diagnosis, its function clearly involves identifying potential medical conditions.
No
The device description explicitly states that the device consists of a monitor and an arm cuff, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: This device measures blood pressure and pulse rate by analyzing the pulse pressure wave data from the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate and detecting possible AFib by analyzing pulse pressure wave data. It's for home screening and not intended to replace traditional diagnostic methods.
Therefore, the Omron Blood Pressure Monitor with AFib Detection Feature falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OXY, QXY
Device Description
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.
Additionally, the Monitor may be used with the Omron Connect mobile application ("App"), an optional software-only accessory residing on a consumer smart device which connects to the device via Bluetooth Low Energy (BLE) and transfers information on completed device recordings for storage and redisplay.
When the measurement is complete, if atrial fibrillation has not been detected in the reading, and the time/date appear alternately.
If atrial fibrillation is detected in the reading, the device displays the "Possible AFib" icon and furthermore displays the characters "AF" in place of blood pressure readings. No blood pressure or pulse rate readings are displayed to the user as shown below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults (22 years or older)
Intended User / Care Setting
user / home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The overall study was a prospective, non-randomized, multi-center study. The study enrolled 267 subjects with and 292 without a known diagnosis of atrial fibrillation into two separate cohorts. Key exclusion criteria included the presence of a pacemaker or implantable cardioverterdefibrillator, heart failure class III or IV, and arterio-venous shunt. Subjects in the without cohort must not have any known diagnosis of AF. To be enrolled in the AF cohort, the subject must be in atrial fibrillation at the time of data collection.
Upon enrollment, the participant had the 12-lead ECG electrodes applied by the Investigator, and participants used the requisite cuff of the Omron BP Monitor with AFib screening on their upper arm. Then the participant would sit in a chair with their feet on the floor, rest their arm on a table so that the cuff is same level as their heart. Lastly, the investigator started the 12-lead ECG recording device and Omron monitor simultaneously. The participant was coached to remain still and do not talk until the measurement process was complete.
Three independent board-certified cardiologists reviewed all ECG recordings and assigned a classification of "Interpretable" or "Uninterpretable" classification means that it is difficult to perform interpretation of AFib due to low signal quality in the ECG reading. If the ECG is "Interpretable", the adjudicators classified the ECG readings into "AFib is observed (AFib)" or "AFib is not observed (non-AFib)". If "AFib is observed (AFib)", the adjudicator will indicate which ECG Lead(s) the AFib is observed. If the readers disagreed on the diagnosis, the final interpretation was determined by the simple majority rule.
The study enrolled a total of 573 subjects at 5 investigational sites.
There were 14 cases excluded from the study and their subject information included:
- . Three (3) cases where the quality of the ECG waveform was poor, and the reader was not confident in interpreting them.
- One (1) case where measurement was not possible due to device deficiency in the ECG . device.
- Four (4) cases of protocol deviation where BP measurement was not performed. ●
- . Four (4) cases of protocol deviation where ECG data was missing.
- One (1) case of protocol deviation where the subject was a patient with an implanted ● pacemaker.
- . One (1) case of protocol deviation of inappropriate cuff size.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study (prospective, non-randomized, multi-center study)
Sample Size: 573 subjects enrolled (267 subjects with AFib, 292 subjects without AFib initially in the modified ITT subpopulation, after exclusions total 559 subjects for performance analysis for each device).
Key Results: The study met the protocol specified primary endpoint.
| Device | Sensitivity | Specificity | ||||
|---|---|---|---|---|---|---|
| Result | 95% CI | p-value | Result | 95% CI | p-value | |
| OMRON BP Monitor with | ||||||
| HEM-FL31 cuff | 0.9509 | 0.9249 - 0.9769 |
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR
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))
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Oscillometric-based, over-the-counter, atrial fibrillation notification feature. An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user.
NEW REGULATION NUMBER: 21 CFR 870.1135
CLASSIFICATION: Class II
PRODUCT CODE: OXY
BACKGROUND
DEVICE NAME: 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))
SUBMISSION NUMBER: DEN230076
DATE DE NOVO RECEIVED: November 13, 2023
SPONSOR INFORMATION:
Omron Healthcare, Inc. % Veranex, Inc. 224 Airport Parkway San Jose, California 95110
INDICATIONS FOR USE
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:
1
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.
LIMITATIONS
The possible AFib detection feature evaluates for a possibility of AFib Only. It will not detect other potentially life-threatening arrhythmias or diseases, such as a possibility of other cardiac arrhythmias or heart attack.
Do NOT adjust medication (including altering your use of any drug or treatment) based on readings from this blood pressure monitor.
Do NOT postpone/stop regular checkups or physician visits based on the results that you are getting from this monitor.
DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
Not intended for use by individuals under age 22.
Not intended for use if you have an implanted defibrillator or pacemaker.
Not intended for use if you are pregnant.
Safety and effectiveness in patients with peripheral arterial disease (PAD) have not been established.
Not intended for the diagnosis, treatment, or management of AFib.
2
It does NOT continuously monitor your heart and therefore cannot alert you if AFib happens at any other time. This monitor cannot detect all forms of AFib. If the irregularity of the heart rhythm is too small, it may not be detected.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
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.
Image /page/2/Picture/4 description: The image shows an Omron blood pressure monitor and cuff. The monitor displays a systolic reading of 118, a diastolic reading of 78, and a pulse of 70. The monitor also displays the time as 7:30 and indicates that the reading is the latest. The cuff is black and has the Omron logo on it.
Figure 1
Additionally, the Monitor may be used with the Omron Connect mobile application ("App"), an optional software-only accessory residing on a consumer smart device which connects to the device via Bluetooth Low Energy (BLE) and transfers information on completed device recordings for storage and redisplay.
When the measurement is complete, if atrial fibrillation has not been detected in the reading, and the time/date appear alternately.
If atrial fibrillation is detected in the reading, the device displays the "Possible AFib" icon and furthermore displays the characters "AF" in place of blood pressure readings. No blood pressure or pulse rate readings are displayed to the user as shown below.
3
Image /page/3/Figure/0 description: The image shows a digital display with the time 8:00 AM at the top left. There is a small icon of a person with the number 1 next to it at the top right. In the center of the display, the letters 'AF' are shown in a large digital font. At the bottom left, there is a message that says 'Possible AFib' with a heart icon.
Figure 2
SUMMARY OF NONCLINICAL/BENCH STUDIES
SOFTWARE
The monitor has a Basic Documentation Level. Appropriate documentation was provided to support the validation of the software for Basic Documentation in accordance with the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," (issued June 14, 2023). Documentation describing the software/firmware, software specifications, architecture design, software development environment, revision level history, unresolved anomalies, and cybersecurity provide the foundation that the software will operate in a manner as described in the specifications. Risk Management/Hazard Analysis was performed to characterize software risks including device malfunction and measurement related errors. The submission included verification and validation (V&V) testing to ensure the mitigation measures were successful.
PERFORMANCE TESTING - BENCH
| Test | Purpose | Method | Acceptance Criteria | Results |
|---|---|---|---|---|
| Bench Testing for | ||||
| confirming the | ||||
| influence of body | ||||
| movement on | ||||
| possible Afib | ||||
| detection | The purpose of this test is | |||
| to demonstrate that low | ||||
| levels of motion below the | ||||
| error threshold of the | ||||
| device do not have a | ||||
| clinically significant effect | ||||
| on the atrial fibrillation | ||||
| detection accuracy of the | ||||
| proposed device. | (b) (4) | PASS |
USABILITY TESTING
Usability Testing was provided in accordance with the FDA Guidance Document, "Applying Human Factors and Usability Engineering to Medical Devices- Guidance for Industry and Food and Drug Administration Staff" (issued February 02, 2016).
4
Sixty (60) participants participated in the human factors validation study to demonstrate the usability of the blood pressure monitor. The testing was performed in a simulated-use environment associated with self-selecting, setting up, and using the blood pressure monitor. All subjects responded to critical tasks by responding to the output of the monitor.
Testing identified critical tasks as those tasks where the user does not understand the output from the device, fails to seek medical care despite symptoms or modifies their treatment plan based on the output. Each task was assessed for completion and success criteria were clearly defined. Overall, usability testing demonstrated that the AFib Detection Feature is safe and has appropriate performance for the intended users, uses, and use environments.
SUMMARY OF CLINICAL INFORMATION
The study objective is to assess the AFib classification performance of OMRON BPMs with the AFib Detection Feature. The performance of the BPM-A (OMRON BPM with cuff HEM-FL31: BP7460) and BPM-B (OMRON BPM with cuff HEM-RML31: BP5460) was evaluated by sensitivity and specificity as calculated by comparing output data of the subject devices to ground truth. Ground truth for AFib identification was established from ECG adjudication performed by multiple independent expert adjudicators.
Methods
The overall study was a prospective, non-randomized, multi-center study. The study enrolled 267 subjects with and 292 without a known diagnosis of atrial fibrillation into two separate cohorts. Key exclusion criteria included the presence of a pacemaker or implantable cardioverterdefibrillator, heart failure class III or IV, and arterio-venous shunt. Subjects in the without cohort must not have any known diagnosis of AF. To be enrolled in the AF cohort, the subject must be in atrial fibrillation at the time of data collection.
Upon enrollment, the participant had the 12-lead ECG electrodes applied by the Investigator, and participants used the requisite cuff of the Omron BP Monitor with AFib screening on their upper arm. Then the participant would sit in a chair with their feet on the floor, rest their arm on a table so that the cuff is same level as their heart. Lastly, the investigator started the 12-lead ECG recording device and Omron monitor simultaneously. The participant was coached to remain still and do not talk until the measurement process was complete.
Three independent board-certified cardiologists reviewed all ECG recordings and assigned a classification of "Interpretable" or "Uninterpretable" classification means that it is difficult to perform interpretation of AFib due to low signal quality in the ECG reading. If the ECG is "Interpretable", the adjudicators classified the ECG readings into "AFib is observed (AFib)" or "AFib is not observed (non-AFib)". If "AFib is observed (AFib)", the adjudicator will indicate which ECG Lead(s) the AFib is observed. If the readers disagreed on the diagnosis, the final interpretation was determined by the simple majority rule.
5
Study Endpoints
Primary Endpoint
Sensitivity and specificity of the AFib Detection Feature in detecting AF compared with physician-adjudicated 12-lead ECG. The acceptance criteria that the sensitivity and specificity should be statistically significant to the target goal (85%).
Secondary Endpoint
- . Subgroup analyses of sensitivity and specificity (Age, Gender, Race, Weight/BMI, Arm size and Site)
- Comparison of ECG reading results of the clinical study and ECG reading results by . independent adjudicators.
Results
Subject characteristics
The study enrolled a total of 573 subjects at 5 investigational sites. Subject disposition is provided in Figure 4.
Image /page/5/Figure/9 description: The image is a flowchart titled "Figure 3" that shows the flow of subjects through a study. The study started with 654 subjects screened, and 80 screen failures and 1 withdrawal resulted in 573 subjects enrolled. 14 subjects were excluded from mITT due to protocol deviations, device deficiency, and ECG interpretation issues, resulting in 267 subjects in the mITT subpopulation AFib and 292 subjects in the mITT subpopulation Non-AFib.
The median age was 69 years, ranging from 22-93. Comparing to the Non-Affb cohort, subjects in the AFib cohort were older (mean age 73.0 vs 57.4) and less likely to be female (32.2% vs 67.1%).
6
There were 14 cases excluded from the study and their subject information included:
- . Three (3) cases where the quality of the ECG waveform was poor, and the reader was not confident in interpreting them.
- One (1) case where measurement was not possible due to device deficiency in the ECG . device.
- Four (4) cases of protocol deviation where BP measurement was not performed. ●
- . Four (4) cases of protocol deviation where ECG data was missing.
- One (1) case of protocol deviation where the subject was a patient with an implanted ● pacemaker.
- . One (1) case of protocol deviation of inappropriate cuff size.
The results indicate that the study met the protocol specified primary endpoint as shown below.
| Device | Sensitivity | Specificity | ||||
|---|---|---|---|---|---|---|
| Result | 95% CI | p-value | Result | 95% CI | p-value | |
| OMRON BP Monitor with | ||||||
| HEM-FL31 cuff | 0.9509 | 0.9249 - 0.9769 |