(153 days)
The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.
The Wrist-type Fully Automatic Digital Blood Pressure Monitor is consist of sphygmomanometer main body and cuff. The mainbody contains ABS housing, LCD, keys, measurement control module, pneumatic control module, power supply module. The Wrist-type Fully Automatic Digital Blood Pressure Monitor is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The device with an inflatable cuff wrapping around the patient's wrist and the cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minutes. The cuff can measure pressure range from 0 to 300mmHg, and the pulse rate range from 30 to 180 beats/min.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the ISO 81060-2:2018+AMD2020 standard for clinical investigation of automated noninvasive sphygmomanometers.
| Acceptance Criteria (from ISO 81060-2:2018+AMD2020) | Reported Device Performance (Model DBP-2208, Cuff 13.5-21.2cm) | Reported Device Performance (Model DBP-2242, Cuff 12.5-23cm) |
|---|---|---|
| Method 1: | ||
| Average difference for Systolic Blood Pressure ≤ ±5 mmHg | 0.84 mmHg | 0.87 mmHg |
| Standard deviation for Systolic Blood Pressure ≤ 8 mmHg | 5.25 mmHg | 5.22 mmHg |
| Average difference for Diastolic Blood Pressure ≤ ±5 mmHg | 0.21 mmHg | 0.20 mmHg |
| Standard deviation for Diastolic Blood Pressure ≤ 8 mmHg | 4.92 mmHg | 4.93 mmHg |
| Method 2: | ||
| Average difference for Systolic Blood Pressure ≤ ±5 mmHg | 0.84 mmHg | 0.87 mmHg |
| Standard deviation for Systolic Blood Pressure ≤ Maximum permissible standard deviation (based on mean difference, from Table 1 in document) | 4.52 mmHg ( |
§ 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).