# K242821: EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Feb 20, 2025 after 155 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN170073 (2018). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221330: BriefCase, Aidoc Medical, Ltd. (2022) Summary page 5.

## Indications for use
EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computer-aided triage and notification software indicated for use in the analysis of chest X-ray (CXR) images in adults. 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. Findings are flagged when the ETT distal tip is assessed as being more than 7 cm above the carina, less than 3 cm above the carina, or when it is below the carina (i.e in the right or left mainstem bronchus). 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 is tested in the single lumen endotracheal tube, while it may trigger a false prioritization alert in the case of properly positioned double lumen ETT. EFAI ETTXR analyzes cases using deep learning algorithms to identify suspected malpositioned ETT findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI ETTXR is not intended to direct attention to specific portions of an image or to anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out malpositioned ETT or otherwise preclude clinical assessment of chest radiographs.

Source page: https://510kreport.com/device/K242821
Methodology: https://510kreport.com/methodology