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510(k) Data Aggregation
(249 days)
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and
The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.
The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn is connected to the 03 Module. Up to two 03 Sensors can be connected to each 03 Module and both sensors can be connected to a patient.
The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root in turn is powered by either AC power or internal rechargeable batteries.
The O3 System provides the following key measurements:
- Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site, including cerebral tissue
- Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2
- Area Under the Limit (AUL index): Index that quantifies the duration (amount of time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user-defined rSO2 low alarm limit (LAL)
- Delta SpO2 (ΔSpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
The provided document describes the Masimo O3 Regional Oximeter System, specifically focusing on the O3 Pediatric Sensor, and its equivalence to predicate devices (K160526 and K082327). The document outlines non-clinical and clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for accuracy are presented as ARMS (Accuracy Root Mean Square) values.
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (O3 Pediatric Sensor) |
|---|---|---|
| rSO2 Measurement Accuracy | ||
| Adults ≥ 40kg (using O3 Large Sensor - Predicate) | Absolute ARMS, 4% for SavO2 of 45%-85% | N/A (this is predicate performance) |
| Trending ARMS, 3% for SavO2 of 45%-85% | N/A (this is predicate performance) | |
| Pediatrics ≥ 5 kg and |
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