1. (a) Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.

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

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

   2. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:

      1. (i) Alarm testing must be performed;
      2. (ii) Continuous use thermal stability testing must be performed;
      3. (iii) Humidity output testing must be performed; and
      4. (iv) Blender performance testing must evaluate fraction of inspired oxygen (FiO2) blending accuracy.
   3. (3) Performance data must validate cleaning instructions for any reusable components of the device.
   4. (4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.
   5. (5) Software verification, validation, and hazard analysis must be performed.

   6. (6) Labeling must include:

      1. (i) A description of available FiO2 ranges for different flowrates and inlet gas pressures;
      2. (ii) Instructions for applicable flowrates for all intended populations;
      3. (iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;
      4. (iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and
      5. (v) A description of all alarms and their functions.

[83 FR 54007, Oct. 26, 2018]