(328 days)
The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.
The arm-type series use an inflatable cuff which wraps around the patient's upper arm. 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 minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
The provided document describes the acceptance criteria and a clinical study conducted to demonstrate the substantial equivalence of the JOYTECH Fully Automatic Digital Blood Pressure Monitor (K173024) to its predicate devices. The study aimed to prove the accuracy of the blood pressure monitors.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on the ISO 81060-2 Standard.
There are two methods for evaluation:
Method 1: Mean difference and standard deviation of differences.
| Metric | Acceptance Criteria | Arm-type Device Performance (Systolic/Diastolic) | Wrist-type Device Performance (Systolic/Diastolic) |
|---|---|---|---|
| Mean difference (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).