(a) CPR aid without feedback—(1) Identification. A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.

(2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9.

(b) CPR aid with feedback—(1) Identification. A CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim.

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

(i) Nonclinical performance testing under simulated physiological or use conditions must demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use.

(ii) Labeling must include the clinical training, if needed, for the safe use of this device and information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations, e.g., adult, pediatric and/or infant).

(iii) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.

(iv) For devices containing software, software verification, validation, and hazard analysis must be performed.

(v) Components of the device that come into human contact must be demonstrated to be biocompatible.

(vi) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user.

(3) Premarket notification. The CPR Aid with feedback device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter if it does not contain software (e.g., is mechanical or electro-mechanical) and is in compliance with the special controls under paragraph (b)(2) of this section, subject to the limitations of exemptions in §870.9.

[81 FR 33134, May 25, 2016]