Acumen Assisted Fluid Management (AFM) Software Feature

K233984

Edwards Lifesciences, LLC · cleared 2024-08-02 · product code QMS · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“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.”
AlgorithmThe device uses a core AFM algorithm and an additional AFM Prompt Reclassifier (AFM PR) algorithm. The core algorithm provides fluid bolus prompts, and the PR algorithm re-assesses these prompts based on real-time hemodynamic data to improve patient responsiveness.
source quote (p.5)
“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. ... With this submission, Edwards is seeking clearance for the addition of 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 AFM algorithm. 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.”
Adaptive (vs locked)Yes
source quote (p.5)
“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 AFM algorithm. 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.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=307 patients · 9 site(s)

endpoints: impact on the response rate of the AFM Software Feature's fluid bolus prompts due to the addition of AFM Prompt Reclassifier algorithm; improvement in response rate for "Fluid Bolus Suggested" prompts

standards: ANSI/AAMI/IEC 62304, FDA's Guidance on Content of Premarket Submissions for Software Contained in Medical Devices, General Principles of Software Validation, Applying Human Factors and Usability Engineering to Medical Devices

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233984