(181 days)
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients of ages 20 -70 with wrist circumference from 13.5 cm to 21.5 cm and BMI
Accurate Mini Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spotcheck of pulse rate. Measurement is performed on the wrist at the radial artery. This blood pressure monitor uses the pulse wave transit time with the hemodynamic method to measure the systolic and diastolic blood pressure and pulse rate. This device serves to measure the systolic and diastolic blood pressure and pulse rate of adults in a non-invasive manner.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Accurate Mini Non-invasive blood pressure monitor (AMB-001)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ISO 81060-2:2018) | Reported Device Performance (Achieved) | Pass/Fail |
|---|---|---|---|
| Blood Pressure | SBP | DBP | |
| Mean Bias (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).