(176 days)
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm (when prescribed or used under the care of a physician). The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use.
The Omron Model BP7900 Blood Pressure Monitor + EKG ("BP7900") is a battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system intended for home use.
The BP7900 is intended for use in adult patients with arm circumferences between 17cm and 42cm. The device can be used with two different arm cuffs, the HEM-CS24-B and HEM-RML31-B which are adjustable to ranges of 17-22cm and 22-42cm. respectively. Other than the difference in circumference, the two cuffs function in the same manner.
The device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/minute. The results of the BP and pulse rate analysis are displayed on the front of the BP7900 for the user. In order to utilize the device, the user must also pair the BP7900 to a smartphone which employs the "Omron connect" app. This app is intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app makes use of the cleared AliveCor Heart Monitor algorithm (K142743) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters. Readings can be stored in the app for archiving and review by the user.
In addition to the BP measurement capabilities, the BP7900 also incorporates electrodes capable of gathering ECG data from the user. This can be done either concurrently with BP measurement, or as a separate function. To initiate the ECG, the user places a thumb on each of the right and left electrodes on the top face of the BP7900 and places two or more fingers in contact with the electrodes on the right and left side of the BP7900. The thumb electrodes measure at a rate of 300 samples/second as a single-lead ECG between left and right thumbs. The two remaining finger electrodes on the sides of the BP7900 are used for noise reduction purposes. The single-lead ECG data is transmitted via ultrasonic acoustics to the nearby smartphone with the cleared AliveCor Heart Monitor or OMRON Connect App. These two applications are effectively the same, with the only difference being branding. The cleared app allows the user to view their ECG and the results of analysis using the AliveCor algorithm (cleared under K142743) which detects the presence of atrial fibrillation, and normal sinus rhythm.
The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823. All software V&V testing performed and submitted in this 510(k) utilized this algorithm.
The operation of the device is intended for home use. Functions and other features that are controlled by the end user include: applying the arm cuff to the arm, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archiving and review by the user.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the ECG analysis for atrial fibrillation, bradycardia, and tachycardia detection.
Part 1: Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Omron Model BP7900 Blood Pressure Monitor + EKG primarily relate to its substantial equivalence to predicate devices for blood pressure measurement and ECG recording and analysis. For the ECG analysis specifically distinguishing atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm, the device leverages the algorithm from the AliveCor KardiaAI (K181823) and AliveCor Heart Monitor (K142743). Therefore, the device's performance for these ECG detections is implicitly expected to meet the established performance of these cleared devices.
Since specific numerical acceptance criteria or reported device performance for the ECG detection capabilities (sensitivity, specificity, accuracy) of the BP7900 itself are not explicitly provided in this document, we must infer that the substantial equivalence claim relies on the prior clearance of the AliveCor algorithms. The document states:
- "The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823." (Page 5)
- "The BP7900 employs the algorithm used for the AliveCor Heart Monitor. The BP7900 does not have an "Irregular Heartbeat Detection" feature which Omron BPMs normally have (estimated from measured BP pulse). Instead, it has an irregular pulse detection feature to identify possible AF, tachycardia which are estimated from ECG waveforms, not from blood pressure pulse." (Page 6)
- "Yes, includes ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician). Same as Heart Monitor. Bradycardia and Tachycardia detection same as reference device." (Page 10, "Irregular Heart Beat Detection" row)
Given this, the table below reflects an interpretation based on the provided text, implying that the acceptance for device performance is met by using a previously cleared and validated algorithm.
| Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Implied by Substantial Equivalence and Algorithm Use) |
|---|---|
| ECG rhythm analysis for detecting the presence of atrial fibrillation (consistent with AliveCor Heart Monitor - K142743) | Performed by the same cleared AliveCor Heart Monitor algorithm, therefore expected to meet its established performance for AF detection. |
| ECG rhythm analysis for detecting the presence of bradycardia (consistent with AliveCor KardiaAI - K181823) | Performed by the same cleared AliveCor KardiaAI algorithm, therefore expected to meet its established performance for bradycardia detection. |
| ECG rhythm analysis for detecting the presence of tachycardia (consistent with AliveCor KardiaAI - K181823) | Performed by the same cleared AliveCor KardiaAI algorithm, therefore expected to meet its established performance for tachycardia detection. |
| ECG rhythm analysis for detecting the presence of normal sinus rhythm (consistent with AliveCor Heart Monitor - K142743 and AliveCor KardiaAI - K181823) | Performed by the same cleared AliveCor Heart Monitor/KardiaAI algorithms, therefore expected to meet its established performance for normal sinus rhythm detection. |
| Software Verification and Validation performed (Page 17) | All software V&V testing performed and submitted to demonstrate safety and effectiveness. |
| Nonclinical performance testing against predicate devices (Page 17) | Conducted to support a determination of substantial equivalence (general statement, specific performance metrics not provided here for ECG). |
| Electrical safety, electromagnetic compatibility, and electrostatic discharge requirements met per IEC60601 and 80601 (Page 17) | Successfully passed these requirements. |
| Biocompatibility of patient-contacting materials met per ISO 10993-1 (Page 17) | Successfully passed these requirements. |
Part 2: Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for an independent test set for the ECG detection performance of the BP7900 itself. The justification for the ECG detection capabilities (AF, bradycardia, tachycardia, normal sinus rhythm) relies entirely on the fact that the BP7900 utilizes the same algorithm as the previously cleared AliveCor Heart Monitor (K142743) and AliveCor KardiaAI (K181823) devices.
Therefore, any test set and data provenance information would refer to the studies originally conducted for the AliveCor devices, not a new, independent study for the BP7900's ECG detection performance. This document does not provide details of those original AliveCor studies.
Part 3: Number of Experts and Qualifications for Ground Truth
Similar to Part 2, the document does not provide details about the number and qualifications of experts specifically for the BP7900's ECG detection capabilities. This information would have been part of the original AliveCor submissions (K142743 and K181823). The BP7900's clearance for ECG detection is predicated on the re-use of these already cleared algorithms.
Part 4: Adjudication Method for the Test Set
As no specific new test set for the BP7900's ECG detection performance is detailed in this document, no adjudication method is described. This information would refer to the original AliveCor studies.
Part 5: Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance specifically for the Omron BP7900. The device's ECG capabilities are based on a standalone AI algorithm (from AliveCor) that performs the detection. Whether the original AliveCor clearances involved such MRMC studies is not detailed here.
Part 6: Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone (algorithm only) performance was done, not for the BP7900 as a new, independent study, but through the pre-existing clearance of the AliveCor Heart Monitor (K142743) and AliveCor KardiaAI (K181823) algorithms. The BP7900 integrates these already validated algorithms. The document explicitly states: "The proposed BP7900 device utilizes the same ECG analysis algorithm including capabilities to detect the presence of bradycardia and tachycardia as that used in the AliveCor KardiaAI device cleared under K181823." (Page 5, and Page 18 under "Summary" and "Substantial Equivalence"). This phrasing indicates reliance on the standalone performance of those previously cleared algorithms.
Part 7: Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the original AliveCor algorithms. However, for ECG rhythm analysis, ground truth is typically established by:
- Expert Consensus: Multiple board-certified cardiologists or electrophysiologists independently reviewing ECG tracings and reaching a consensus diagnosis.
- Adjudicated Clinical Data: ECGs from patients with confirmed diagnoses based on a combination of clinical information, reference standard tests, and expert review.
Given the nature of ECG interpretation, expert consensus and/or adjudicated clinical data would be the most probable ground truth methods for the AliveCor algorithms.
Part 8: Sample Size for the Training Set
The document does not provide the sample size for the training set used to develop the AliveCor algorithms. This information would be specific to the original AliveCor submissions (K142743 and K181823).
Part 9: How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set of the AliveCor algorithms was established. As mentioned in Part 7, it would typically involve expert review and/or adjudicated clinical data from cardiologists or electrophysiologists.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).