MiroCam® Capsule Endoscope System

The MiroCam® Capsule Endoscope System (MC1200-B) is a wireless capsule endoscope intended for visualization of the small bowel mucosa to detect abnormalities in adults and children from two years of age. It includes a Suspected GI Bleeding Indicator (SGIB) feature that marks video frames suspected of containing blood or red areas. The capsule operates for 12 hours and is single-use only.

The MC1200-B is technologically and functionally equivalent to the predicate MC1600-B, sharing the same core technology (Human Body Communication/HBC), system architecture, and intended use. The differences are limited to frame rate (3 fps for MC1200-B versus 6 fps for MC1600-B) and minor configuration changes in the receiver and software. The receiver was changed from MR1100 to MR2000, and software was updated from MiroView U 3.0 to MiroView U Plus+ 1.1.

Not stated in this summary.

The subject device MC1200-B is substantially equivalent to predicate devices K143663 and K180732 (both MiroCam® Capsule Endoscope Systems) because they share identical dimensions, materials, optical components, internal circuitry, and HBC communication method. The frame rate difference (3 fps vs. 6 fps) does not impact clinical usability or safety and does not raise new questions of safety or effectiveness. The system continues to deliver equivalent performance in signal reception and data handling as confirmed by testing.