§ 868.2250 Monitor for opioid induced impairment of oxygenation.

(a) Identification. A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance data under anticipated conditions of use must demonstrate that the device performs as intended and include the following: (i) Comparison to a clinically relevant reference method to demonstrate and support the accuracy and level of sensitivity and specificity for detection of opioid induced impairment of oxygenation; (ii) Demonstration of the consistency of the output and representativeness of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment; (iii) Performance reported in clinically significant and distinct subpopulations and intended use environments; (iv) For devices using algorithms based on machine learning, the clinical validation must be completed using a dataset that is separate from the training dataset; and (v) Simulated use testing of hardware and sensors to characterize accuracy and precision across the intended use population. (2) Software description, verification, and validation based on comprehensive hazard analysis must be performed. Software documentation must include: (i) Full characterization of technical parameters of the software, including any algorithm(s); (ii) Specification of acceptable incoming sensor data quality control measures; and (iii) Justification for the validity of the algorithm(s) (e.g., clinical relevance/importance of decision threshold). (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Performance testing of sensor hardware to characterize sensor accuracy and precision; and (ii) Compatibility testing of sensors with other hardware and software components of the device. (4) Usability assessment must be provided to demonstrate that intended device users can safely and correctly use the device. (5) All components of the device that contact the skin must be demonstrated to be biocompatible. (6) Performance testing must demonstrate the electromagnetic compatibility, wireless coexistence, electrical safety, thermal safety, and mechanical safety of any hardware components and sensors of the device. (7) Labeling must include the following: (i) A summary of the clinical validation data, including relevant characteristics of the included subpopulations and use environments in the clinical study, and performance metrics, including sensitivity, specificity, positive predictive value, and negative predictive value for each of the subpopulations, use environments, and opioid types; (ii) Principles of sensor operation, including warnings for how to avoid interfering with sensor readings; (iii) Information for preventing an overdose, recognizing signs of an overdose, and treating an overdose; (iv) Warnings identifying that the device is not designed to differentiate between the target condition (e.g., opioid-induced respiratory depression) and other conditions that may cause a false reading (e.g., obstructive sleep apnea); (v) Warnings against overreliance on the device; and (vi) A warning regarding the need for supervised use with awareness of effective countermeasures (e.g., naloxone) in case of an overdose.