(156 days)
The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.
The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.
Here's an analysis of the provided text regarding the OxiCheck device, focusing on acceptance criteria and study information:
The document (K023565) describes the Caradyne OxiCheck, an oxygen analyzer. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the document primarily focuses on technical specifications and similarities to predicate devices, rather than detailed clinical study data typically associated with new medical device approvals.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a separate section. However, the "Design and Specifications" and "Performance Standards" tables effectively serve as the acceptance criteria that the device claims to meet.
| Attribute/Acceptance Criteria (Implicit) | Reported Device Performance (OxiCheck) |
|---|---|
| Measurement range | 0 to 100% O₂ |
| Display resolution | 1% O₂ |
| 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).