BriefCase-Triage for Malpositioned Endotracheal Tube
Contact Information
www.aidoc.com/contact-support/ or email:info@aidoc.com
Release Stage
Release Date
Version
Regulatory Approval
Please find attached the ETT-01 510(k) summary.
Global Availability
US, EU (CE Marked), UK (UKCA Marked), Canada (MDEL), Australia (ARTG), New Zealand, Israel (AMAR), UAE and South Africa.
Summary
The Malpositioned Endotracheal Tube solution is a radiological computer-aided triage and notification software indicated for use in the analysis of frontal chest X-ray (CXR) images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina. The Malpositioned Endotracheal Tube solution uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. When suspected findings are detected, users receive notifications that include compressed preview images. These previews are for informational purposes only and are not intended for diagnostic use beyond the initial notification. The results of the Malpositioned Endotracheal Tube solution are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Ultimately, notified clinicians are responsible for viewing full images per the standard of care.
Uses and Directions
Intended Use
The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive findings of Malpositioned Endotracheal Tube
Primary Users
The Malpositioned Endotracheal Tube solution is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for malpositioned ETT are Emergency physicians, radiologists, interventional radiologists, intensive care physicians, internal medicine physicians, pulmonologists and anesthesiologists
How to Use
The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The results of the Malpositioned Endotracheal Tube solution are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images.
Target Population
patients Adults or transitional adolescents aged 18 and older.
Cautioned Out-of-Scope Settings
Cautioned Out-of-Scope Settings
The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device does not provide results when the carina is not well-visualized on the x-ray image. The device does not discriminate types of ETTs, as such a properly positioned double lumen ETT may trigger a false prioritization alert. Only for use in workflow triage, and only for use by appropriately trained medical specialists. Please refer to BriefCase-Triage User Guide (UG0009) for further information on warnings and precautions.
EHR Compatibility
EHR-agnostic
This solution works independently of specific EHR systems and can be integrated with most healthcare IT infrastructures.