---
kind: "section"
citation: "21 C.F.R. § 868.1505"
title: "21"
number: "868.1505"
heading: "Ventilatory electrical impedance tomograph."
url: "https://uscodex.org/cfr/21/868.1505"
---

# §868.1505. Ventilatory electrical impedance tomograph.

- (a) **Identification.** A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
    - (i) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing;
    - (ii) Real time evaluation of local impedance variation;
    - (iii) Plethysmogram accuracy testing; and
    - (iv) **Use life testing of reusable components.**
  - (3) Performance data must validate reprocessing instructions for any reusable components of the device.
  - (4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
  - (5) Software verification, validation, and hazard analysis must be performed.
  - (6) Labeling must include the following:
    - (i) Guidance for interpretation of the images generated;
    - (ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device;
    - (iii) A use life for any reusable components; and
    - (iv) **Instructions for reprocessing any reusable components.**

## Notes

### Amendments

[84 FR 15098, Apr. 15, 2019]

### 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

[84 FR 15098, Apr. 15, 2019]