(a) Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;

(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;

(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;

(4) Performance data should validate accuracy and precision and safety features;

(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,

(6) Appropriate software verification, validation, and hazard analysis should be performed.