Infrascanner Model 2500 (Model 2500)
Infrascan, Inc.The Infrascanner Model 2500 is a noninvasive medical device designed to help detect traumatic brain hematomas in patients with head injuries. It uses near-infrared light to measure differences in hemoglobin concentration in the brain, which indicate the presence of hematomas. The device aids clinicians in quickly assessing patients for further CT scans, improving early diagnosis and treatment in hospital settings.
Intended Use
Detection of traumatic supratentorial hematomas as small as 3.5 mL and as deep as 2.5 cm from the brain surface, as an adjunctive device in acute hospital settings to assess patients for CT scans, for patients aged 2 years and older with suspected traumatic intracranial hematoma.
Technology
A noninvasive near-infrared spectroscopy (NIRS)-based device that measures regional hemoglobin concentration differences in the brain using a sensor optically coupled to the patient's head via disposable light guides. It uses an 808 nm diode laser (upgraded from 100 mW to 200 mW) and a silicon detector with filtering, along with an automatic algorithm for hematoma detection, providing graphical and numerical outputs.
Performance
Performance was validated by phantom testing simulating various hematoma sizes, depths, and skin colors; optical density measurements showed less than 5% difference between 100 mW and 200 mW laser settings. Clinical testing on 672 patients showed high sensitivity (~91-100%) for detecting hematomas within the detection range. The 200 mW setting enabled measurement completion in very dark-skinned patients where 100 mW was insufficient, demonstrating equivalent clinical performance and safety to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/15/2024
7 months - 2
FDA Approval
12/12/2024
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