Affirm 400

The Affirm 400 is a surgical microscope accessory comprising excitation and emission optical filters that enable fluorescent visualization of suspected grade III and IV gliomas during neurosurgery using the 5-ALA imaging agent. It includes software that allows surgeons to switch between normal white light and fluorescence modes on a digital surgical microscope.

The device uses a VIS-UV LED blue light source (390–420 nm excitation filter; 510–700 nm emission filter) compared to the predicate's xenon lamp white light source (400–430 nm excitation; 430–800 nm emission). Both devices employ identical 5-ALA fluorescent agent, produce real-time fluorescent images, include pre-operative check test cards, and are non-sterile accessories without patient-contacting materials.

Not stated in this summary.

The Affirm 400 is substantially equivalent to the predicate device BLUE 400 because both share identical product code, regulation, medical specialty, indications for use (fluorescent visualization of grade III–IV gliomas), intended patient population, and visualization results. Non-clinical performance testing demonstrated equivalent or comparable performance across excitation spectrum, emission filter spectrum, power/irradiance, fluorescence detection sensitivity, and image quality metrics, despite using different light source technologies.