(205 days)
The Blood Pressure Monitor is indented to measure or electrocardiogram (ECG) in home or healthcare facilities environment. The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to measure, display, store and review adults' single-channel ECG rhythms and gives some suggested symptoms such as regular beat, low HR and high HR. The ECG part of the device is for Rx only, and the blood pressure part is for OTC.
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure, pulse rate and ECG of an individual intended for home use. By using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm, 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 deternines pulse rate, as well as systolic and diastolic blood pressure, which is a well-known technique in the market called the "oscillometric method". In addition to the BP measurement, the device also incorporates electrodes capable of gathering ECG data from the user. This can be done as a separate function. To initiate the ECG, the user places one or more fingers in contact with the electrodes on the right and left side of the device. The electrodes measure a single-lead ECG between left and right fingers. The single-lead ECG data is displayed on the LCD. The main components of the Blood Pressure Monitor are the main unit, cuff unit and ECG unit (only for BP2). The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Nylon and polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the pump, exhaust valve, bluetooth transmission, cuff and ECG circuit including the electrodes. The subiect devices are powered by Li-ion Polymer Battery. The device has Irreqular beat: If the change speed of heart rate exceeds a certain threshold during measurement, is judged as irreqular heartbeat. The subject device includes bluetooth transmission which can transfer data to other device through the bluetooth connection such as smart phone.
Here's a breakdown of the acceptance criteria and study information for the Shenzhen Viatom Technology Co., Ltd. Blood Pressure Monitor (K193348), based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
Blood Pressure Measurement (based on ISO 81060-2)
| Acceptance Criteria (Overall) | Reported Device Performance |
|---|---|
| Mean difference and standard deviation between device and reference. | "The accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2" |
| Individual difference distribution (e.g., within 5, 10, and 15 mmHg). | Implied as passing ISO 81060-2 |
ECG Measurement (based on IEC 60601-2-47)
| Acceptance Criteria (Overall) | Reported Device Performance |
|---|---|
| Validation of ECG function (Lead I and Lead II). | "All the performance of ECG function (Lead I and Lead II) were validated and the results is Pass." |
| Accuracy of irregular beat, High HR, and Low HR detection. | "The ECG performance of the subject device is tested by bench test including the irregular beat High HR and Low HR and has been verified by the required accuracy." |
| Accuracy within full claimed range for operating/storage temperature. | "The subject devices have been validated all the full claimed range according to the IEC 60601-1, IEC 80601-2-30, IEC 60601-2-47 and IEC 60601-1-11." |
| Functional performance and evaluation of high-frequency use, cleaning/disinfection for healthcare facilities. | "The high-frequencyuse performance of the product life and cleaning /disinfection is evaluated and passed, the device can meet the requirements of healthcare facilities." |
Specific Accuracy Parameters (from Comparison Table)
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | Within ± 3mmHg or 2% of reading (for predicate) | ± 3mmHg (for subject device) |
| Pulse Accuracy | Within 5% of HR reading (for predicate) | 2 bpm (for subject device) |
| HR Accuracy | No specific value for predicate, but for device: 30 to 300 bpm | ± 2 bpm or 2%, whichever is greater; (for subject device) |
2. Sample Size Used for the Test Set and Data Provenance
-
Blood Pressure Clinical Investigation:
- Sample Size: 85 patients (39 males and 46 females).
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a prospective clinical study conducted by the manufacturer for this submission. The "same arm sequential method" was adopted.
-
ECG Clinical Investigation:
- Sample Size: 35 patients (24 males and 11 females).
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a prospective clinical study conducted by the manufacturer for this submission. "Comprising with the cleared device" was adopted during the clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth for either the blood pressure or ECG test sets.
- Blood Pressure: The ground truth was established using a "manual Mercury Sphygmomanometer" as a reference device. It's implied that trained personnel would operate this for comparison, but their specific qualifications are not detailed.
- ECG: The ground truth for the ECG investigation was established by "comprising with the cleared device," suggesting comparison against an existing, cleared ECG device. There is no mention of expert review of the ECG waveforms themselves for ground truth.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in either the blood pressure or ECG test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or described in the provided document. The clinical studies focused on comparing the device to a reference (for BP) or a cleared device (for ECG).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance (algorithm only) was evaluated for both the blood pressure and ECG functionalities.
- Blood Pressure: The device's automated oscillometric method was compared directly to a manual mercury sphygmomanometer.
- ECG: The device's ability to measure, display, store, and detect suggested symptoms (regular beat, irregular beat, low HR, high HR) was tested against a cleared device and bench tests for accuracy. The note states, "The ECG performance of the subject device is tested by bench test including the irregular beat High HR and Low HR and has been verified by the required accuracy." This indicates standalone algorithmic evaluation.
7. The Type of Ground Truth Used
- Blood Pressure: The ground truth used was comparison to a manual Mercury Sphygmomanometer.
- ECG: The ground truth used was comparison to a cleared device and bench test verification for specific parameters like irregular beat, high HR, and low HR.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This submission focuses on the performance evaluation of the final product, implying that any internal development/training would have occurred prior to these validation studies.
9. How the Ground Truth for the Training Set Was Established
Since no information on a training set is provided, there is no information on how its ground truth would have been established.
§ 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).