§882.4950. Diagnostic neurosurgical microscope filter.
21 C.F.R. § 882.4950
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.
Classification. Class II (special controls). The special controls for this device are:
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:
Spectrum and intensity of the illumination source;
Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope;
Excitation power and power density;
Optical path loss from illumination source to objective lens or microscope camera;
Homogeneity of the excitation light at the focal plane;
Fluorescence detection sensitivity;
Verification of calibration or preoperative procedures; and
If camera-based, spectral sensitivity of the camera.
Labeling must include:
Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following:
Illumination spectrum and power density; and
Excitation and emission filter spectra.
Instructions for calibration or preoperative checks to ensure device functionality prior to each use;
Instructions for use with compatible surgical operating microscopes, external light sources, and cameras;
A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and
A warning that the device is not a standalone diagnostic.
Notes, amendments, and revision history
Amendments
[86 FR 73973, Dec. 29, 2021]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.
Amendments
[86 FR 73973, Dec. 29, 2021]