Critical Care Suite with Enteric Tube Positioning AI Algorithm

Critical Care Suite with Enteric Tube Positioning AI Algorithm is a software tool that analyzes frontal chest and abdominal x-ray images to automatically detect and localize enteric tubes inserted nasally or orally, identifies the tube tip and side port, and highlights the diaphragm and airways. It is intended for use by qualified healthcare professionals and radiologists to assist in assessing enteric tube placement in both adult and pediatric patients, but does not replace professional review of x-ray images.

The device uses AI deep learning algorithms for on-device computation integrated onto x-ray systems like the AMX Navigate mobile system. It produces visualization overlays identifying enteric tubes, tips, side ports, diaphragm, and airways, with outputs delivered as secondary DICOM images and DICOM tags to PACS or x-ray systems. Unlike the predicate device which focuses on endotracheal tubes in chest x-rays only, this device targets enteric tubes in chest and abdominal x-rays including stomach imaging.

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GE HealthCare argues substantial equivalence based on the same technological characteristics, deployment mechanism, and safety profile as the predicate device (K211161 Critical Care Suite with Endotracheal Tube Positioning AI Algorithm). Both are Class II automated radiological image processing software with on-device AI computation and DICOM-based outputs. Clinical validation on 954 independent ground-truth images across multiple sites and vendors demonstrated high sensitivity (0.992) and specificity (0.975) for enteric tube detection, with acceptable performance across patient demographics and image quality variations.