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.

Device Description

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.

AI/ML Overview

The FDA 510(k) summary for the Acumen Assisted Fluid Management (AFM) Software Feature describes the acceptance criteria and the study conducted to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as a numerical target, but the overall goal was to demonstrate an improvement in the response rate for "Fluid Bolus Suggested" prompts due to the addition of the AFM Prompt Reclassifier (AFM PR) algorithm. This improvement should confirm that a greater number of these prompts lead to desired changes in the patient's stroke volume.	The study "demonstrated an improvement in response rate for 'Fluid Bolus Suggested' prompts, thus demonstrating that the AFM PR algorithm met the predefined acceptance criteria." The results showed that the differences in fluid bolus suggestions introduced by the AFM PR algorithm do not raise any safety and effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The algorithm performance was analyzed on an archived dataset consisting of 1229 data points from 307 patients.
Data Provenance: The data came from the US IDE Study, G170204. The study involved 9 independent U.S. sites. The data is retrospective as it was an "archived dataset."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The study uses physiological response (change in stroke volume) as the outcome measure, implying a physiological ground truth rather than expert interpretation of images or other data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the ground truth (physiological response), a traditional adjudication method for subjective assessments might not be directly applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC comparative effectiveness study was not explicitly mentioned or described.
The study focuses on the algorithm's performance in improving the response rate of its suggestions, rather than comparing human reader performance with and without AI assistance. The device offers "suggestions" and the "decision to administer a fluid bolus is made by the clinician."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone algorithm performance study was done. The document states, "Algorithm performance was analyzed on the archived dataset... The validation was to demonstrate the impact on the response rate of the AFM Software Feature's fluid bolus prompts due to the addition of AFM Prompt Reclassifier algorithm." This implies evaluating the algorithm's predictions against the measured physiological outcomes.

7. The Type of Ground Truth Used

The ground truth used is physiological response/outcomes data. Specifically, the "desired change in stroke volume (SV)" following AFM recommendations was used to measure the "response rate."

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only mentions the "archived dataset from the US IDE Study, G170204" used for algorithm performance analysis/validation.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly describe how the ground truth for the training set was established. It focuses on the validation of the AFM Prompt Reclassifier algorithm using an existing dataset. Given that the core AFM algorithm was granted in De Novo DEN190029, the ground truth for its original training would likely have involved similar physiological outcome data from clinical studies where fluid administration decisions were made and subsequent stroke volume changes were observed.

Summary

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August 2, 2024

Edwards Lifesciences, LLC Kshama Pai Manager, Regulatory Affairs One Edwards Way Irvine. California 92614

Re: K233984

Trade/Device Name: Acumen Assisted Fluid Management (AFM) Software Feature Regulation Number: 21 CFR 870.5600 Regulation Name: Adjunctive Open Loop Fluid Therapy Recommender Regulatory Class: Class II Product Code: OMS Dated: July 3, 2024 Received: July 3, 2024

Dear Kshama Pai:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Aneesh S. Deoras -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality

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Enclosure

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Indications for Use

Submission Number (if known)

K233984

Device Name

Acumen Assisted Fluid Management (AFM) Software Feature

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #:	K233984	510(k) Summary	Prepared on: 2024-07-02
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Contact Details	21 CFR 807.92(a)(1)
-----------------	---------------------

Applicant Name	Edwards Lifesciences, LLC
Applicant Address	One Edwards Way Irvine CA 92614 United States
Applicant Contact Telephone	9492504457
Applicant Contact	Ms. Kshama Pai
Applicant Contact Email	kshama_pai@edwards.com

Device Name	21 CFR 807.92(a)(2)
-------------	---------------------

Device Trade Name	Acumen Assisted Fluid Management (AFM) Software Feature
Common Name	Adjunctive open loop fluid therapy recommender
Classification Name	Adjunctive Open Loop Fluid Therapy Recommender
Regulation Number	870.5600
Product Code	QMS

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K223865	Acumen Assisted Fluid Management (AFM) Software Feature on Hemo Sphere Advanced Monitoring Platform	QMS

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

Device Description Summary

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 AFM 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.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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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 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.

Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject and predicate device (most recently cleared in K223865 on June 09, 2023) have the same intended use and indications for use.

Technological Comparison

21 CFR 807.92(a)(6)

The subject and predicate device have the following similarities:

• The subject and predicate devices utilize the same predictive core AFM algorithm and the same fundamental technology) to obtain AFM output fluid bolus prompts.

• The functionality and use of the AFM Software Feature remains unchanged. No new output prompts or suggestions are generated and hence, the modifications made to the AFM Software Feature do not constitute a new intended use.

· The timing, volume, and number of fluid bolus prompts of the AFM Software Feature remain equivalent between the subject and predicate device.

• The sensitivity, specificity, positive value and negative predictive value remain the same between the subject device and predicate device.

The following key difference exists between the subject and predicate devices:

· The subject device utilizes an additional algorithm with the cleared core AFM algorithm, which leads to an improved response rate of the "Fluid Bolus Suggested" prompts (i.e., greater number of these prompts lead to desired changes in patient's stroke volume).

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Software verfication and validation activities were performed in accordance with ANSI/AAM/IEC 62304, Medical Device Software -Software Life Cycle Processes, FDA's Guidance on Content of Premarket Submissions for Software in Medical Devices (issued June 14, 2023), General Principles of Software Validation (issued January 11, 2002), and Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016), as well as the specified in De Novo Grant, DEN190029.

Algorithm performance was analyzed on the archived dataset from the US IDE Study, G170204. This dataset consisted of 1229 data points from 307 patients from 9 independent U.S. sites. The validation was to demonstrate the impact on the response rate of the AFM Software Feature's fluid bolus prompts due to the addition of AFM Prompt Reclassifier algorithm. The resulting rates for the AFM PR algorithm and predicate/cleared core AFM algorithm were compared and demonstrated an improvement in response rate for "Fluid Bolus Suggested" prompts, thus demonstrating that the AFM PR algorithm met the predefined acceptance criteria. The results demonstrate that the differences in the fluid bolus suggestions introduced by the AFM PR algorithm do not raise any concerns of safety and effectiveness for the cleared AFM Software feature. These non-clinical design control activities form the basis for the substantial equivalence between the predicate/ existing AFM Software feature.

The results of these performance testing activities demonstrate that the specified design requirements were met, and that the modifications in scope of this submission do not adversely and effectiveness of the AFM Software Feature. Based on the information presented within this 510(k) and the testing performed, the AFM Software Feature with subject modifications for introduction of AFM PR algorithm is substantially equivalent to the predicate AFM Software Feature (last cleared in K223865 on June 09, 2023).

Regulation Number and Section

§ 870.5600 Adjunctive open loop fluid therapy recommender.

(a)
Identification. The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient's 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.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must fulfill the following:
(i) A summary of the clinical performance testing must include the relevant patient demographics, and any statistical techniques used for analyzing the data;
(ii) Subjects must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified;
(iii) Testing must demonstrate the recommendation consistency using the expected range of data sources and data quality encountered in the intended patients, users, and environments; and
(iv) Testing must evaluate the relationship between algorithm recommendations, therapeutic actions, and predicted physiological event or status.
(2) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must be provided, including:
(i) A full characterization of the software technical parameters, including algorithms;
(ii) A description of the expected recommendation, accounting for differences in patient condition and environment;
(iii) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) that affect the device's recommendations;
(iv) A characterization of algorithm sensitivity to variations in user inputs;
(v) A characterization of sensor accuracy and performance;
(vi) A description of sensor data quality control measures; and
(vii) Safeguards to reduce the possibility of fluid overload.
(3) A scientific justification for the validity of the algorithm(s) must be provided. This justification must include non-clinical verification and validation of the algorithm calculations and clinical validation using an independent data set.
(4) A human factors and usability engineering assessment must be provided.
(5) Labeling must include:
(i) A description of what the device measures, how the device decides to issue recommendations, and the expected range of frequency of recommendations, while accounting for differences in patient condition and environment;
(ii) Detailed information regarding limitations of the device's algorithm, and key assumptions made when the device issues a recommendation;
(iii) Warnings identifying sensor acquisition factors that may impact measurement results;
(iv) Warnings identifying user errors that affect the device's recommendations;
(v) Detailed information regarding the expected impact of user input errors on the device recommendations;
(vi) Guidance for interpretation of the device's recommendations, including a description that the recommendation is adjunctive to other physical vital sign parameters and patient information;
(vii) Description of the impact of the compatible sensor(s) on the device's performance;
(viii) The expected performance of the device for all intended patients, users, and environments;
(ix) Relevant characteristics of the patients studied in the clinical validation (such as age, gender, race or ethnicity, and patient condition) and a summary of validation results; and
(x) Description of the software safeguards that are in place to prevent fluid overload, and description of any limitation of the software safeguards.