(238 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches (22 cm to 42 cm). The device is intended for indoor use.
The Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "Oscillometric method".
When using the device, users will be able to monitor their blood pressure and their pulse rate. The device will give metrics about heart health:
- Systolic blood pressure
- Diastolic blood pressure
- Pulse rate
The device should be placed on the left upper arm during all the measurement duration. The measurement lasts between 30 seconds and 3 minutes depending on the selected mode by the user. The measurement can be longer if the user selects the triple measurement mode (three blood pressure measurements in a row to give an average).
Users will get an instant feedback after the measurement thanks to a LED matrix located on the tube part of the device.
WPM05 (BPM Connect)
The device synchronizes with Withings application and Withings server via Bluetooth or Wi-Fi connectivity.
WPM06 (BPM Connect Pro)
The device synchronizes with third-party applications by cellular, Wi-Fi or Bluetooth connectivity. On the mobile application, users have access to their historic and more contents around each metrics.
Here's a breakdown of the acceptance criteria and study information for the Blood Pressure Monitor (K223374), based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily refers to the relevant standards and states that the device meets them. It doesn't present a specific table of numerical acceptance criteria alongside the device's numerical performance for all parameters. However, it does highlight the performance specific to blood pressure and pulse measurement.
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy | |
| ISO 80601-2-30: 2017 & ISO 81060-2: 2018 (Mean error and SD of differences for SBP and DBP) | Not over the limits of ISO 81060-2: 2018 |
| Blood Pressure Measurement Range | |
| IEC 80601-2-30 (Range for subject device) | 0mmHg ~ 285mmHg |
| Predicate Device (for comparison) | 0mmHg ~ 299mmHg |
| Blood Pressure Measurement Accuracy (Specific to device) | Within ±3mmHg (0.4kPa) or 2% of reading |
| Pulse Measurement Range | |
| Subject Device (via IEC 80601-2-30 demonstration) | 40-180 beat/minute |
| Predicate Device (for comparison) | 40-199 beat/minute |
| Pulse Measurement Accuracy | ±5% of reading |
| Biocompatibility | |
| ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Passed (Biocompatibility evaluation conducted) |
| Electrical Safety | |
| IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Demonstrated safety and performance |
| Wireless Coexistence | |
| ANSI C63.27: 2017, AAMI TIR69: 2017 | Testing conducted |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Data): 135 qualified healthy adult subjects.
- Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer's location in China, it is highly probable the clinical study was conducted there. The study appears to be prospective as it involves "qualified healthy adult subjects" being tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications for establishing the ground truth in the clinical validation study. For ISO 81060-2 adherence, typically a specific protocol involving independent, trained observers (often physicians or technicians certified in blood pressure measurement) taking reference measurements with a validated mercury sphygmomanometer or auscultatory method is followed.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method. In the context of ISO 81060-2 clinical validation, ground truth is established through a standardized reference measurement method (e.g., auscultation by trained observers), and discrepancies are usually handled by comparing the device readings to these established reference readings. It's not a consensus-based adjudication in the same way an imaging study might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for interpretative devices (e.g., AI for radiology) where human readers are making diagnoses. This device is a measurement device (blood pressure monitor), and its accuracy is validated against established reference measurement methods, not through human reader interpretation.
6. Standalone Performance
- Yes, a standalone performance study was done. The clinical data section explicitly states: "The device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard specifically evaluates the accuracy of the automated device (algorithm only) against a reference standard.
7. Type of Ground Truth Used
- Clinical Ground Truth (Reference Standard Measurement): The ground truth was established through a standardized clinical reference measurement method, as prescribed by ISO 81060-2. This typically involves simultaneous or near-simultaneous measurements by trained observers using a validated reference sphygmomanometer (e.g., mercury or calibrated oscillometric device for reference) with the test device.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. While the device uses an "Oscillometric method" which is a "well-known technique in the market," the specific neural network or machine learning component that would require a distinct training set is not detailed. The oscillometric method itself relies on empirically derived algorithms and signal processing, often refined with large datasets, but these are usually part of the initial engineering and development, not explicitly detailed as a 'training set' in the 510(k) summary for such a device.
9. How the Ground Truth for the Training Set Was Established
Since the document does not mention a distinct "training set" or explicit machine learning model in the context of the submission, it does not provide information on how the ground truth for a training set was established. The oscillometric method generally works by analyzing oscillations in cuff pressure during deflation to determine systolic, diastolic, and mean arterial pressure using proprietary algorithms derived from physiological principles and extensive validation studies over time.
§ 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).