(a) Identification. An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).

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

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include the following:

(i) Evaluation of the effect of confounding variables, like skin pigmentation, on performance;

(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; and

(iii) Evaluation of all adverse events, including skin irritation.

(2) Software verification, validation, and hazard analysis must be performed. Documentation must include:

(i) Technical specifications of the software, including software algorithm(s) and its inputs and outputs; and

(ii) Specification of acceptable incoming sensor data quality control measures.

(3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmography signal quality and validate any alarms.

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

(5) Performance testing must support the electrical safety and electromagnetic compatibility of the electrical components of the device.

(6) Human factors and usability testing must demonstrate the following:

(i) The caregiver can correctly use the device based solely on reading the device labeling; and

(ii) The caregiver can correctly interpret the device outputs and understand next steps to take based on the outputs.

(7) Labeling must include:

(i) Instructions for identifying the intended use population of the device, including populations where the device should not be used, and conditions of monitoring;

(ii) A description of what the device measures and outputs to the caregiver, including instructions for the interpretation of results and appropriate actions;

(iii) Situations in which the device may not operate at an expected performance level; and

(iv) Instructions for cleaning the device and cleaning frequency.