21 CFR §868.1505

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)The patient-contacting components of the device must be demonstrated to be biocompatible.
   2. (2)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
      1. (i)Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing;
      2. (ii)Real time evaluation of local impedance variation;
      3. (iii)Plethysmogram accuracy testing; and
      4. (iv)Use life testing of reusable components.
   3. (3)Performance data must validate reprocessing instructions for any reusable components of the device.
   4. (4)Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
   5. (5)Software verification, validation, and hazard analysis must be performed.
   6. (6)Labeling must include the following:
      1. (i)Guidance for interpretation of the images generated;
      2. (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;
      3. (iii)A use life for any reusable components; and
      4. (iv)Instructions for reprocessing any reusable components.