Cardiovascular · 510(k) · 2024
eCARTv5 Clinical Deterioration Suite (eCART)
AgileMD, Inc.. Cleared by FDA on 21 June 2024 under submission K233253, product code QNL (medium-term adjunctive predictive cardiovascular indicator). What FDA's record says, in FDA's words.
Device record · K233253
- Device. eCARTv5 Clinical Deterioration Suite (eCART)DEVICE
- Company. AgileMD, Inc.COMPANY
- Decision. 21 June 2024, 510(k), substantially equivalent (traditional review); received 28 September 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QNL, Medium-Term Adjunctive Predictive Cardiovascular IndicatorCODE
- Regulation. 21 CFR 870.2210, Class IIREG
- Source. FDA database entry · decision document (9 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.
eCART is a software product that provides automated risk stratification and early warning for impending patient deterioration, signified as the composite outcome of death or ICU transfer. It is intended to be used on hospitalized ward patients 18 years of age or older by trained medical professionals. As a clinical decision support device, eCART’s risk score and trend analysis is intended to aid clinical teams in identifying which patients are most likely to clinically deteriorate. eCART provides additional information and does not replace the standard of care or clinical judgment. eCART scoring is initiated by the documentation of any vital sign on an adult ward patient. The device calculates risk only from validated EHR data, such as vitals that have been confirmed by a registered nurse (RN); unvalidated data streaming from monitors/devices will not be used until confirmed by a healthcare professional. The product predictions are for reference only and no therapeutic decisions should be made based solely on the eCART scores.
The product code's definition, from FDA's classification record. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
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.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QNL. 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 QNL, in Cardiovascular, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
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