Affirm 800

The Affirm 800 is a fluorescence imaging module that integrates with a surgical microscope to visualize blood flow in cerebral vessels during neurosurgery. It uses Indocyanine Green (ICG) dye activated by near-infrared light (740–800 nm excitation, 820–900 nm detection) to display real-time images of vessel patency and blood flow on a 3D monitor, helping surgeons assess vessel occlusion and bypass graft success.

The Affirm 800 uses identical optical and hardware components to its predicate: 2 white-light LEDs and 13 infrared LEDs; 740–800 nm bandpass excitation filter; 820–900 nm detection filter; motorized 8.9:1 zoom; integrated camera in microscope head; and identical ICG fluorescent agent. The main difference is the addition of a color map feature in the subject device, which the predicate lacks.

Not stated in this summary. The document references FDA guidance documents on software submissions and device changes but does not cite specific ISO, IEC, or ASTM consensus standards.

The Affirm 800 is substantially equivalent because it has identical indications for use (intraoperative cerebral vessel visualization in neurosurgery), identical design principles, materials, and optical/hardware specifications as the DIR 800 predicate device. Design verification testing confirmed equivalent performance in NIR fluorescence sensitivity, spatial and temporal noise, stereoscopic imaging quality, and depth penetration across all key parameters. Although the Affirm 800 adds a color map feature, this enhancement does not alter the fundamental intended use or risk profile and does not require a new 510(k).