(183 days)
The intended use of the Ceramatec® Handi oxygen analyzer is to monitor the oxygen concentration in the patient-breathing environment.
The Ceramated Handi oxygen analyzer is comprised of a galvanic oxygen sensor and an analyzer module. The galvanic oxygen sensor produces a millivolt output that is proportional to the partial pressure of oxygen in the monitored gas. The analyzer module contains an electronic circuit that converts the millivolt output of the sensor to a digital percent-oxygen reading on a liquid-crystal display (LCD).
Here's an analysis of the Ceramatec Handi Oxygen Analyzer based on the provided text, focusing on acceptance criteria and the study that proves its adherence:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ceramatec Handi Oxygen Analyzer are implicitly established by demonstrating substantial equivalence to a legally marketed predicate device, the MSA Miniox® IA oxygen analyzer. The device performance is then compared against these criteria, which are the specifications of the predicate device.
| Acceptance Criteria (Predicate Device Specification - MSA Miniox® IA) | Reported Device Performance (Ceramatec® Handi) |
|---|---|
| Display Range: 0-100% oxygen | Display Range: 0-99% oxygen |
| Display Resolution: 0.1% oxygen | Display Resolution: 1% oxygen |
| Warm-up time: none required | Warm-up time: none required |
| Operating Temperature Range: 0 - 40°C | Operating Temperature Range: 10 - 40°C |
| Operating Humidity Range: 0-95% RH non-condensing | Operating Humidity Range: 0-95% RH non-condensing |
| Accuracy: ±3% full-scale | Accuracy: ±3% full-scale |
| Linearity: ±2% full-scale | Linearity: ±2% full-scale |
| Sensor type: galvanic fuel sensor 0-100% O2 | Sensor type: galvanic fuel sensor 0-100% O2 |
| Sensor Operating Life: 12 months under normal operating conditions | Sensor Operating Life: 12 months under normal operating conditions |
| Sensor Shelf Life: 6 months | Sensor Shelf Life: 6 months |
| Storage Temperature: -20 - 55 °C | Storage Temperature: -15° - 50 °C |
| 90% FS Response Time: |
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).