The Affirm 800 is a surgical imaging device that helps neurosurgeons visualize blood flow and vessel patency in the brain during operations. It works by using near-infrared light to activate a fluorescent dye (Indocyanine Green) injected into the bloodstream, allowing surgeons to see detailed images of cerebral vessels on a 3D monitor in real time. This aids in assessing occlusions and blood flow in vessels, improving surgical outcomes.
Intended Use
The Affirm 800 is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral vessel branch occlusion, as well as intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.
Technology
The Affirm 800 module works with the Digital Surgical Microscope to emit excitation light in wavelengths 740-800 nm to activate Indocyanine Green (ICG) fluorescence. The fluorescence emitted by blood vessels is captured via microscope optics and image sensors and displayed on a 3D monitor. The system can record and replay video of the fluorescent imaging during surgery.
Performance
Design verification testing confirmed equivalence with predicate device for image quality, sensitivity to near-infrared fluorescence, stereoscopic 3D display performance, and real-time image visualization. An animal study with porcine models showed clinicians rated image quality highly for vessel visualization. Software validation followed FDA guidelines to ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
9 months - 2
FDA Approval
6/27/2025
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