Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);

The Confocal Microprobe Imaging System is a probe-based confocal laser endomicroscopy device that enters the human body through an endoscope's working channel to provide microscopic imaging of tissue microstructure. It enables identification and visualization of cells, blood vessels, and their organization or architecture within body cavities and surgical sites.

The device operates at 488nm laser wavelength (±2nm) with Class 2 laser classification and a minimum bending radius of 20mm. It achieves frame rates ≥120 frames/second in continuous or pulsed scanning mode, compared to the predicate's 12 frames/second. Maximum tensile loads are <500g for the microprobe and <1000g for connector and fiber bundle, with IPX7 fluid ingress rating. The subject device does not contain sodium fluorescein and does not visualize the central nervous system.

Biocompatibility per ISO 10993-5, 10993-10, 10993-23, and 10993-11; reprocessing per ISO 17664-1, ASTM F3208-20, ANSI/AAMI ST98-2022, and AAMI TIR12:2020; electrical safety and EMC per IEC 60601-1, 60601-2-18, 60601-1-2, and laser safety per IEC 60825-1; software validation per FDA General Principles guidance (2002); cybersecurity per FDA September 2023 guidance.

The subject device has the same intended use and substantially similar technological characteristics as the predicate Cellvizio 100 Series (K191144). Both are confocal laser endomicroscopy systems with fiber optic probes for tissue imaging, share the same product code (OWN), regulatory class (II), and regulation (21 CFR 876.1500). Differences in frame rate, laser classification, and bending radius do not create new safety or effectiveness risks; higher performance specifications do not degrade safety. Exclusion of central nervous system visualization and sodium fluorescein are restrictions that narrow intended use rather than expand risk. All performance validation testing met acceptance criteria, demonstrating functional equivalence.