Cardiovascular · 510(k) · 2024
Eko Low Ejection Fraction Tool (ELEFT)
Eko Health, Inc.. Cleared by FDA on 28 March 2024 under submission K233409, product code QYE (reduced ejection fraction machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K233409
- Device. Eko Low Ejection Fraction Tool (ELEFT)DEVICE
- Company. Eko Health, Inc.COMPANY
- Decision. 28 March 2024, 510(k), substantially equivalent (traditional review); received 6 October 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QYE, Reduced Ejection Fraction Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity. The interpretations of heart sounds and ECG offered by the software are meant only to assist healthcare providers in assessing Left Ventricular Ejection Fraction � 40%, who may use the result in conjunction with their own evaluation and clinical judgment. It is not a diagnosis or for monitoring of patients diagnosed with heart failure. This software is for use on adults (18 years and older).
The product code's definition, from FDA's classification record. Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QYE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QYE, in Cardiovascular, from Eko Health, Inc., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.