21 CFR 870.2720: Hyperoxia monitoring device adjunct to pulse oximetry.

(a) Identification. A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing under anticipated conditions of use must evaluate the accuracy of hyperoxia monitoring by the device and evaluate all adverse events.

(2) Human factors/usability testing must demonstrate that the user can correctly use the device, based solely on reading the instructions for use.

(3) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) Performance testing must validate the reprocessing instructions for the device, including demonstration of device performance after repeated cleaning and disinfection.

(6) Software verification, validation, and hazard analysis must be performed. Performance testing must demonstrate compatibility with pulse oximeter devices labeled to be compatible with the device.

(7) Labeling must include:

(i) Cleaning and disinfection instructions;

(ii) A summary of the clinical performance testing with the device;

(iii) A warning against over-reliance on device output without using arterial blood gas values for confirmation; and

(iv) Instructions to monitor oxygen delivery and patient clinical/cardiovascular status when device output changes.