(280 days)
The Boppli Infant Blood Pressure Monitor is indicated for use by medically trained personnel in clinical settings, such as the NICU, PICU, CVICU, and emergency or operating room, to continuously monitor diastolic, systolic, and mean arterial blood pressures of neonates and infants, under 5 kilograms in weight, who have a palpable pulse.
The Boppli Infant Blood Pressure Monitor, or Boppli Device, is a non-invasive blood pressure monitor that utilizes a reusable mobile tablet electronic interface (Boppli Bedside) with a single-use non-invasive sensor band (Boppli Band) that is placed on the arm or leg of an infant over a palpable pulse point, such as the radial or dorsalis pedis artery, respectively. The device uses proprietary algorithms to derive the arterial pressure and display systolic (SBP) and diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse rate (PR), and a continuous pressure waveform. The device allows healthcare providers to monitor a neonate's blood pressure in clinical settings.
Here's a breakdown of the acceptance criteria and the study proving the Boppli Infant Blood Pressure Monitor meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Method A: ISO 81060-2) | Reported Device Performance (Method B: ANSI/AAMI SP10) |
|---|---|---|---|
| Primary Endpoint Goal | **MAE |
§ 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).