Infrascanner Model 2500 (Model 2500)

The Infrascanner Model 2500 is a noninvasive near-infrared spectroscopy device that detects traumatic brain hematomas by measuring differences in hemoglobin concentration. It is indicated as an adjunctive tool in acute hospital settings to assess adult and pediatric patients (age 2+) with suspected head trauma, detecting hematomas as small as 3.5 mL and as deep as 2.5 cm from the brain surface. The device is used to rule in the presence of hematoma and guide CT scan decisions, not to rule out hematoma or substitute for CT imaging.

The upgraded Model 2500 differs from the predicate (K211617) solely in laser power output: increased from 100 mW to 200 mW at 808 nm wavelength to improve readings in very dark-skinned individuals. All other components remain identical, including the optical fiber probes, microcontroller processor, detection algorithm, silicon detector with 808 nm filter, power source, and user interface.

IEC 60601-1 (general medical device safety), IEC 60601-1-2 (electromagnetic compatibility), AIM 7351731 (RFID immunity), and IEC 60825-1 (laser safety). Clinical validation was performed against CT imaging in 387 patients at Duke University Global Neurosurgery in Uganda.

The device maintains identical indications for use, intended patient population, measurement principle (NIRS-based hemoglobin detection), probe placement, and all hardware components except laser power. Phantom testing demonstrated substantially equivalent performance between 100 mW and 200 mW across simulated hematoma sizes and depths for varying skin tones. Clinical data from 71 patients showed 100 mW and 200 mW achieved equivalent sensitivity and specificity in detecting hematomas, with the 200 mW version enabling measurements in three very dark-skinned patients where 100 mW could not obtain readings. The laser power increase raises no new safety issues as confirmed by appropriate fusing and control mechanisms.