---
kind: "section"
citation: "21 C.F.R. § 868.5480"
title: "21"
number: "868.5480"
heading: "Isocapnic ventilation device."
url: "https://uscodex.org/cfr/21/868.5480"
---

# §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](/cfr/21/868.5320.md)), oxygen cannulas ([§ 868.5340](/cfr/21/868.5340.md)), masks ([§ 868.5550](/cfr/21/868.5550.md)), valves ([§ 868.5870](/cfr/21/868.5870.md)), resuscitation bags ([§ 868.5915](/cfr/21/868.5915.md)), and/or tubing ([§ 868.5925](/cfr/21/868.5925.md)).
- (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.**

## Notes

### Amendments

[86 FR 68397, Dec. 2, 2021]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

[86 FR 68397, Dec. 2, 2021]