Cardiovascular · 510(k) · 2024
Acumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences, LLC. Cleared by FDA on 2 August 2024 under submission K233984, product code QMS (adjunctive open loop fluid therapy recommender). What FDA's record says, in FDA's words.
Device record · K233984
- Device. Acumen Assisted Fluid Management (AFM) Software FeatureDEVICE
- Company. Edwards Lifesciences, LLCCOMPANY
- Decision. 2 August 2024, 510(k), substantially equivalent (traditional review); received 18 December 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QMS, Adjunctive Open Loop Fluid Therapy RecommenderCODE
- Regulation. 21 CFR 870.5600, Class IIREG
- Source. FDA database entry · decision document (6 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.
The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) Software Feature provides a patient's estimated response to fluid therapy and thethe clinician with physiological i nsight i nto associated hemodynamics. The Acumen AFM Software Feature is intended for use in surgical patients 18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM Software Feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.
The product code's definition, from FDA's classification record. The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patients estimated response to fluid therapy. The 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.
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QMS. 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
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More devices under product code QMS, in Cardiovascular, from Edwards Lifesciences, LLC, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
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