CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR868.5480]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 868 -- ANESTHESIOLOGY DEVICES

Subpart F - Therapeutic Devices

Sec. 868.5480 Isocapnic ventilation device.

(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]