§ 868.1980 Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia.
(a) Identification. This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance testing under anticipated conditions of use must evaluate the location accuracy of anatomical landmarks identified by the device.
(2) Human factors testing must demonstrate that the user can correctly use the device to identify anatomical structures, based solely on reading the instructions for use.
(3) Software verification, validation, and hazard analysis must be performed, including demonstrated compatibility with ultrasound devices labeled to be compatible with the device.
(4) Labeling must include:
(i) The recommended training for safe use of the device;
(ii) Pertinent details of the clinical data collected to evaluate the performance of the device; and
(iii) A warning against over-reliance on device output.
[91 FR 32340, June 1, 2026]