QFX · Diagnostic Neurosurgical Microscope Filter

Neurology · 21 CFR 882.4950 · Class 2

Overview

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 Rationale

Class II (special controls). The special controls for this device are:

Special Controls

In combination with the general controls of the FD&C Act, the diagnostic neurosurgical microscope filter is subject to the following special controls: - (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; - Spectrum of the excitation and emission filter modules when integrated in the (ii) 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 pre-operative procedures; and - (viii)If camera-based, spectral sensitivity of the camera. - (2) Labeling must include: - Identification of the filter characteristics in conjunction with a compatible surgical (i) operating microscope, to include the following: - (A) Illumination spectrum and power density; and - (B) Excitation and emission filter spectra. - (ii) Instructions for calibration or pre-operative 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 - A warning that the device is not a standalone diagnostic. (v)

*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.

Recent Cleared Devices (5 of 5)

Top Applicants

• Carl Zeiss Meditec, AG — 2 clearances
• Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) — 1 clearance
• Leica Microsystems (Schweiz) AG — 1 clearance
• Nico Corporation — 1 clearance