21 CFR §882.4950

1. (a)Identification. A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and verify and validate filter specifications and functional characteristics, including the following:
      1. (i)Spectrum and intensity of the illumination source;
      2. (ii)Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope;
      3. (iii)Excitation power and power density;
      4. (iv)Optical path loss from illumination source to objective lens or microscope camera;
      5. (v)Homogeneity of the excitation light at the focal plane;
      6. (vi)Fluorescence detection sensitivity;
      7. (vii)Verification of calibration or preoperative procedures; and
      8. (viii)If camera-based, spectral sensitivity of the camera.
   2. (2)Labeling must include:
      1. (i)Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following:
         1. (A)Illumination spectrum and power density; and
         2. (B)Excitation and emission filter spectra.
      2. (ii)Instructions for calibration or preoperative checks to ensure device functionality prior to each use;
      3. (iii)Instructions for use with compatible surgical operating microscopes, external light sources, and cameras;
      4. (iv)A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and
      5. (v)A warning that the device is not a standalone diagnostic.