(250 days)
The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.
The subject device, the Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo, is a noninvasive, disposable, single-use device comprising a piezoelectric sensor element and an adhesive strip that is attached to the patient's chest for the purpose of noninvasive respiration/respiratory rate monitoring in infant and neonatal patients (
Here's a breakdown of the acceptance criteria and study details for the Masimo Acoustic Respiration Sensors, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (Arms) |
|---|---|---|
| Respiration Rate Measurement Range | 4-120 breaths per minute | 4-120 breaths per minute (Implied by testing) |
| Respiration Rate Measurement Accuracy | ± 1 breaths per minute, over the entire range | 1.1 breaths per minute (when compared to manual/auditory reference) |
| Body Weight | Infant, Neonate |
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).