(226 days)
The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the "clothes pin" style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination. The COVERox Sheath is supplied non-sterile and is intended for single use only.
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This document is a 510(k) clearance letter from the FDA for a device called "COVERox Sheath." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not a direct assessment of device performance against specific, pre-defined acceptance criteria in the manner requested by your prompt (e.g., accuracy, sensitivity, specificity, or a detailed clinical study).
Therefore, I cannot provide the requested information from the provided text. The document focuses on the regulatory clearance for marketing the device based on its substantial equivalence and intended use as a gross contamination barrier for reusable pulse oximetry finger probes.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).