(a) Identification. An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (§ 868.5320), oxygen cannulas (§ 868.5340), masks (§ 868.5550), valves (§ 868.5870), resuscitation bags (§ 868.5915), and/or tubing (§ 868.5925).

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

(1) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics:

(i) Gas concentration accuracy testing for the range of intended concentrations;

(ii) Airway pressure delivery accuracy testing;

(iii) Supplemental O2 flowrate accuracy testing;

(iv) Alarm testing; and

(v) Use life testing.

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

(3) Labeling must include the following:

(i) Instructions for use;

(ii) A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and

(iii) Use life specification.

[86 FR 68397, Dec. 2, 2021]