Last synced on 23 September 2022 at 11:05 pm

Diagnostic Neurosurgical Microscope Filter

Page Type
Product Code
Definition
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.
Physical State
Microscope filter set that filters light
Technical Method
Utilizes excitation and emission filters to be used with surgical operating microscopes to facilitate visualization of fluorescence within specific wavelength bands.
Target Area
Neurosurgical targets including brain and spinal cord
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4950
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4950 Diagnostic neurosurgical microscope filter

§ 882.4950 Diagnostic neurosurgical microscope filter.

(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]

Diagnostic Neurosurgical Microscope Filter

Page Type
Product Code
Definition
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.
Physical State
Microscope filter set that filters light
Technical Method
Utilizes excitation and emission filters to be used with surgical operating microscopes to facilitate visualization of fluorescence within specific wavelength bands.
Target Area
Neurosurgical targets including brain and spinal cord
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4950
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4950 Diagnostic neurosurgical microscope filter

§ 882.4950 Diagnostic neurosurgical microscope filter.

(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]