(237 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 the output of ECG analysis including detecting the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm, and others. 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 software of the AliveCor, Inc. KardiaMobile System (K191406) 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 Kardia App (part of the KardiaMobile System, K191406) or Omron Connect App (Omron functional equivalent). The cleared app, which is incorporated from the KardiaMobile (K191406), allows the user to view their ECG and the results of analysis using the AliveCor's KardiaAI platform (K181823) which detects the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others.
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 archive and review by the user.
The Omron Model BP7900 Blood Pressure Monitor + EKG received 510(k) clearance based on its substantial equivalence to two predicate devices: the Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) and the AliveCor, Inc. KardiaMobile System (K191406). The primary change in the proposed device is a software update to the onboarding procedure for accessing ECG functionalities, aligning it with the secondary predicate.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is considered substantially equivalent, meaning its performance for key functionalities (blood pressure measurement, ECG recording, and ECG analysis) is expected to be as safe and effective as the predicate devices. The document explicitly states: "With respect to technological characteristics, there are no differences between the proposed and primary predicate devices with respect to the key functionalities blood pressure measurement, ECG recording, or ECG analysis."
The acceptance criteria are implicitly tied to the performance specifications of the predicate devices, particularly the primary predicate (K182579) which the proposed device largely mirrors in hardware and core functionality.
| Feature | Acceptance Criteria (based on predicate K182579) | Reported Device Performance (proposed BP7900) |
|---|---|---|
| Blood Pressure Monitoring | ||
| BP measurement method | Cuff oscillometric method | Cuff oscillometric method |
| Pressure measuring range | 0 to 299mmHg | 0 to 299mmHg |
| Pulse Rate measuring range | 40 to 180 beats/min | 40 to 180 beats/min |
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor |
| Applicable cuff (Arm Circumference) | 17-22cm (HEM-CS24-B), 22-42cm (HEM-RML31-B) | 17-22cm (HEM-CS24-B), 22-42cm (HEM-RML31-B) |
| Accuracy of pressure indicator | Within ±3mmHg or 2% of reading | Within ±3mmHg or 2% of reading |
| Accuracy of pulse rate | Within 5% of reading | Within 5% of reading |
| Inflation Method | Automatic inflation by electric pump | Automatic inflation by electric pump |
| Deflation Method | Automatic pressure release valve | Automatic pressure release valve |
| Display | LCD digital display on device and Smartphone | LCD digital display on device and Smartphone display |
| Body Movement Detection | Yes, for BP measurement | Yes, for BP measurement |
| Communications (BP) | Bluetooth | Bluetooth |
| Memory Capacity (BP) | 90 BP readings in internal memory | 90 BP readings in internal memory |
| Microprocessor (BP) | Determines BP/pulse rate, controls pump/valve/display, detects switch operations, stores results, manages date/time | Determines BP/pulse rate, controls pump/valve/display, detects switch operations, stores results, manages date/time |
| Rapid Exhaust/Deflation Valve | Active electronic control valve | Active electronic control valve |
| Inflation Source | DC rolling diaphragm pump | DC rolling diaphragm pump |
| Controls | START/STOP Button, Connection Button | START/STOP Button, Connection Button |
| Anatomical site (BP) | Upper arm | Upper arm |
| ECG Monitoring | ||
| ECG analysis | Provided by KardiaAI platform (K181823) | Provided by KardiaAI platform (K181823) |
| ECG Detectors (outputs) | Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, Unclassified, Unreadable | Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, Tachycardia, Unclassified, Unreadable |
| ECG recording pulse rate range | 30 to 300 beats/min | 30 to 300 beats/min |
| Communications (ECG) | Ultrasonic Acoustics acquired by phone | Ultrasonic Acoustics acquired by phone |
| Data Acquisition for ECG: Frequency Response | 0.67 - 40Hz | 0.67 - 40Hz |
| Data Acquisition for ECG: ECG channels | Single Channel | Single Channel |
| Data Acquisition for ECG: Resolution | 16-bit | 16-bit |
| Data Acquisition for ECG: Sample Rate | 300 samples/second | 300 samples/second |
| Memory Capacity (ECG) | Essentially unlimited (due to app transmission) | Essentially unlimited (due to real-time transmission to MCP memory) |
| User Interface for ECG | Apple iOS-based or Google Android-based software | Apple iOS-based or Google Android-based software |
| Number of ECG Leads | Single lead, 4 electrodes (2 neutral) | Single lead, 4 electrodes (2 neutral) |
| Anatomical site (ECG) | Left hand fingers to right hand fingers | Left hand fingers to right hand fingers |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was conducted in support of this 510(k) Premarket Notification."
Therefore, there is no information regarding a test set sample size or data provenance (country of origin, retrospective/prospective). The clearance relies on substantial equivalence to predicate devices, supported by nonclinical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was conducted for this specific 510(k) submission, there were no experts used to establish ground truth for a new test set. The ECG analysis relies on the cleared AliveCor KardiaAI platform (K181823), which would have had its own validation studies involving experts. However, details of those studies are not part of this document.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set was created or evaluated for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study was conducted or reported in this 510(k) submission for the proposed device. The device's clearance is based on its substantial equivalence to existing devices and the fact that the changes made (primarily software for onboarding) do not raise new questions of safety or effectiveness. The ECG analysis is performed by the previously cleared KardiaAI platform, which likely had its own validation studies, but those are not detailed here for the proposed device itself.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The document does not detail any new standalone studies for the algorithms within the proposed device. The ECG analysis functionalities are provided by the "KardiaAI platform (K181823)," which was previously cleared. The blood pressure measurement is hardware-based (oscillometric method) with software analysis, and its performance is considered unchanged from the primary predicate. The nonclinical testing performed focused on verifying the software update related to onboarding procedures.
7. The Type of Ground Truth Used
For the current submission, no new ground truth was established as no new clinical studies were conducted. The device's performance is assumed to be equivalent to the predicate devices, which would have been validated against their respective ground truths (e.g., reference blood pressure measurements for the BP monitor, and expert-adjudicated ECGs for the KardiaMobile component).
8. The Sample Size for the Training Set
No information is provided regarding a training set for the proposed device, as no new clinical studies were conducted for this submission. The ECG analysis algorithms ("KardiaAI platform") had their own training sets, but details are not included here.
9. How the Ground Truth for the Training Set Was Established
Not applicable to this submission, as no new training set or ground truth establishment relevant to the device's clearance were detailed. The KardiaAI platform's previous clearance (K181823) would contain this information.
§ 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).