(124 days)
The Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
Discovery 1 is a portable non-invasive Hemodynamic Blood Pressure Monitor powered by an internal rechargeable lithium polymer battery. It contains a pulse wave probe incorporating two LEDs, which can collect the pulse wave to the device.
The provided document describes the FDA 510(k) clearance for the Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor. Here's a breakdown of the acceptance criteria and the study details:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Predicate Device K093981) Coverage for Subject Device | Reported Device Performance (Discovery 1) |
|---|---|---|
| Blood Pressure | ||
| Systolic Range | 90 mmHg ~ 240 mmHg | 50 mmHg ~ 200 mmHg |
| Diastolic Range | 30 mmHg ~ 130 mmHg | 40 mmHg ~ 160 mmHg |
| Accuracy |
§ 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).