Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

CMN Capillary Function with Virtual Expert is medical image processing software for trained professionals that analyzes CT and MRI brain imaging data. It visualizes tissue perfusion, diffusion, and blood volume parameters to help assess hemodynamic status in acute stroke and other conditions with compromised blood flow. The software runs on standard computers or virtual platforms and processes DICOM-compliant imaging data.

The subject device is identical to the predicate device (K230016) except for the addition of CT perfusion post-processing capability. Both devices use DICOM-compliant image acquisition and processing, support standard off-the-shelf computing platforms, and generate hemodynamic parameter maps (rCBF, rCBV, MTT, Tmax, ADC). The CT capability mirrors similar functionality in the reference device (RAPID, K182130).

ISO 13485:2016 (quality management), ISO 14971:2019 (risk management), IEC 62304:2015 (software lifecycle), IEC 62366-1:2015 (usability engineering), NEMA PS 3.1-3.20:2016 (DICOM standard), and FDA guidance on cybersecurity in medical devices and computer-assisted detection devices.

The subject device has identical intended use, indications, and technological principles to the predicate device K230016, differing only by adding CT perfusion post-processing. Performance validation testing using digital phantoms and retrospective clinical data demonstrated the subject device produces accurate hemodynamic parameters comparable to both the predicate and reference devices. Since both MRI functionality is identical to the predicate and CT functionality mirrors the cleared reference device (K182130) using similar algorithms, and no new safety or effectiveness concerns arise from the CT addition, substantial equivalence is established.