(55 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches (13.5 cm to 21.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Environments of Use: Home Patient Population: Adult
This device originally received clearance under 510(k) K123498.
The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure.
The device has a memory function that automatically stores up to 100 of the latest measurements. It can also display an average of the last three values
The device also detects the appearance of irregular heartbeats during measurement.
As originally submitted under 510(k) K123498, the device contained the APS feature. The feature was removed prior to clearance.
This submission is for the addition of the Advanced Positioning Sensor (APS) into the device. The APS is an aid to help the user determine if the cuff is at the correct height in relationship to the heart. The addition of APS does not change the intended use of the device. The addition of APS does not alter the fundamental scientific technology. There are no changes in hardware. There are no changes in the software algorithm which determines blood pressure or pulse rate. The addition of the APS feature is an optional feature which the user can elect to use. The APS feature does not alter the accuracy of the device, but serve to assist the user in positioning the device at the level of the heart.
The provided text describes the Omron BP652N (HEM-6300-Z) with APS, a noninvasive blood pressure measurement system. The submission (K142917) is for the addition of the Advanced Positioning Sensor (APS) feature.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Value (from ANSI/AAMI/ISO 81060-2:2013) | Reported Device Performance (Omron BP652N with APS) |
|---|---|---|
| Accuracy of pressure indicator | +/- 3 mmHg or 2% of reading (from predicate device's specification) | +/- 3 mmHg or 2% of reading |
| Accuracy of pulse rate | +/-5% (from predicate device's specification) | +/-5% |
| Compliance with standards | SP10, IEC 60601-1, IEC 60601-1-2, ISO 10993-1 | Declared compliance with all listed standards |
| Clinical Accuracy (Mean Diff.) | Standard: Mean difference between device and reference |
§ 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).