§ 882.4950. Diagnostic neurosurgical microscope filter.
247 words·~1 min read·
/us/cfr/t21/s§ 882.4950·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
(b)Classification. Class II (special controls). The special controls for this device are:
(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:
(i)Spectrum and intensity of the illumination source;
(ii)Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope;
(iii)Excitation power and power density;
(iv)Optical path loss from illumination source to objective lens or microscope camera;
(v)Homogeneity of the excitation light at the focal plane;
(vi)Fluorescence detection sensitivity;
(vii)Verification of calibration or preoperative procedures; and
(viii)If camera-based, spectral sensitivity of the camera.
(2)Labeling must include:
(i)Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following:
(A)Illumination spectrum and power density; and
(B)Excitation and emission filter spectra.
(ii)Instructions for calibration or preoperative checks to ensure device functionality prior to each use;
(iii)Instructions for use with compatible surgical operating microscopes, external light sources, and cameras;
(iv)A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and
(v)A warning that the device is not a standalone diagnostic. [86 FR 73973, Dec. 29, 2021]
Connections1 cite this
Cited by 1 section
Citation graph
cites case law
§ 882.4950
Diagnostic neurosurgical microscope filter.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source