(89 days)
Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.
Wrist Blood Pressure Monitor mainly consist of pressure sensor, air pump, valve, cuff, main board and plastic case. Wrist Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. The Wrist Blood Pressure Monitor include two models: YJ110, YJ111
The provided text describes the non-clinical testing and a clinical validation study for a Wrist Blood Pressure Monitor (models YJ110, YJ111) to demonstrate its substantial equivalence to a predicate device (K223291).
It is important to note that the document primarily focuses on non-clinical testing (e.g., appearance, safety indices, performance indices, electrical safety, EMC, software verification) and a clinical validation study that demonstrates the accuracy of the device against a reference method, rather than a comparative effectiveness study involving human readers with and without AI assistance. The device is a blood pressure monitor, not an AI-powered diagnostic tool requiring expert interpretation of images. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, expert adjudication, AI standalone performance) would not be applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a detailed table (Table VII-1) of "Inspecting item" with "Inspection content and acceptance standard" and the "Conclusion". Below is a summary, focusing on performance-related criteria:
| Inspecting Item / Acceptance Standard | Reported Device Performance (Conclusion) |
|---|---|
| Appearance and Structure Test: | Pass |
| 1.1 Correct shape, clean surface, no obvious scratches/damage/deformation | Pass |
| 1.2 Text/logo accurate, clear, firm | Pass |
| 1.3 Function clearly marked/indicated | Pass |
| 1.4 Reliable connections, free key activity | Pass |
| 1.5 Display number clear, no missing/breaking | Pass |
| Identification Requirement: | Pass |
| 2.1 Device Identification (traceability, warnings, instructions, parameters) | Pass |
| 2.2 External Packing (wrist circumference, battery info) | Pass |
| 2.3 Specification (manual content, instructions, common arrhythmias, recalibration, measurement method, affected by posture, storage conditions, warranty, neonates, airbag risks, failure method, disinfection, correlation) | Pass |
| 2.4 Low voltage prompt function (battery label, wristband ID) | Pass |
| Safety Index: | Pass |
| 3.1 Maximum band pressure (= 0.267kPa/s) | Pass |
| 4.5.2.3 Blow-by (time to drop 34.67kPa to 2kPa |
§ 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).