21CFR882.1935

(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.