← Product Code [QFX](/productcode/QFX) · K254030

# cCeLL405 (K254030)

_VPIX Medical, Inc. · QFX · Oct 2, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K254030

## Device Facts

- **Applicant:** VPIX Medical, Inc.
- **Product Code:** [QFX](/productcode/QFX.md)
- **Decision Date:** Oct 2, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4950
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/device/K254030](https://fda.innolitics.com/device/K254030)

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