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The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) Software Feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the 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 Acumen AFM Software Feature (core AFM algorithm + AFM Graphical User Interface) was originally granted in De Novo, DEN190029, on November 13, 2020, to inform clinicians about a patient's fluid responsiveness. The performance of the AFM Software Feature in predicting a patient's fluid responsiveness is measured using response rate and is calculated by reporting the percentage of followed AFM recommendations ("Fluid Bolus Suggested" and "Test Bolus Suggested" prompts) that have the desired change in stroke volume (SV), divided by the total number of AFM recommendations. With this submission, Edwards is seeking clearance for the AFM Prompt Reclassifier algorithm (AFM PR algorithm) to the Acumen AFM Software Feature. The AFM Prompt Reclassifier algorithm is intended to be used in conjunction with the core AFM algorithm to re-assess the fluid bolus recommendations provided by the core alqorithm. It analyzes the patient's current hemodynamics for either confirming (corroborating) the original prompt or reclassifying the prompts (i.e., reclassify a "Test Bolus Suggested" prompt to a "Fluid Bolus Suggested" prompt or vice versa). In doing so, it acts as a secondary check for the fluid bolus prompts such that a greater number of the "Fluid Bolus Suggested" prompts lead to the desired change in stroke volume. Through refined prompt adjustments informed by real-time hemodynamic data, the AFM PR algorithm aims to improve patient responsiveness, thereby optimizing the impact of the AFM Software Feature on patient hemodynamics.

The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the 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 Acumen™ Assisted Fluid Management (AFM) Software Feature ("the device") consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (K160552 cleared on June 1, 2016) coupled with an Acumen 10 sensor (which was called FloTrac IO sensor in K152980 cleared on January 19, 2016) connected to a radial arterial catheter. The goal of AFM is to reduce the barriers slowing the utilization of perioperative goal directed therapy (PGDT) during surgical procedures by easing the implementation of PGDT, recognizing patterns of fluid responsiveness (i.e. hemodynamic data and past responses to fluid), and suggesting when fluid administration may improve the patient's hemodynamic state. The clinician is responsible for reviewing the AFM software suggestion in addition to a patient's current hemodynamic state and, if the clinician agrees, the clinician can deliver fluid in the standard-of-care fashion. Alternatively, if the clinician disagrees with the fluid suggestion, it can be rejected as the clinician chooses to not deliver any fluid. The AFM algorithm can be used on the EV1000 Clinical Platform to help maintain patient fluid balance throughout a surgery. The AFM algorithm continuously estimates patient fluid responsiveness (percent increase in Stroke Volume, A SV%) using current hemodynamic parameters and past responses to fluid boluses. The Acumen AFM software feature is intended to simplify the implementation of fluid management protocols/perioperative goal directed therapy (PGDT). When an Acumen IO sensor is connected and the AFM algorithm is initialized. the EV1000 Clinical Platform will provide notifications to the user when fluid is recommended by the AFM algorithm. The AFM algorithm learns from the stroke volume response to each fluid bolus to determine if a patient is in a fluid responsive or pre-load dependent state. The patient's tidal volume must be ≥ 8 mL/kg while using the AFM software feature. Throughout the case. the algorithm tracks and records bolus and patient response information to adapt its suggestions based off of the individual patient. In order for the algorithm to analyze each fluid bolus, the start and stop time of each infusion must be entered in the system, as well as the volume of the fluid bolus. The algorithm uses data from the current patient in order to predict their fluid responsiveness; this data is not used by the algorithm to determine fluid responsiveness in future patients. Each bolus can be administered with the fluid, rate, and volume at the discretion of the clinician. Additionally, any fluid bolus can be declined or discarded as deemed appropriate by the clinician. The AFM algorithm will analyze fluid boluses within the following range: Volume: 100 - 500 mL: Rate: 1 - 10 L / hr.