Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5600](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5600) → QMS — Adjunctive Open Loop Fluid Therapy Recommender

# QMS · Adjunctive Open Loop Fluid Therapy Recommender

_Cardiovascular · 21 CFR 870.5600 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QMS

## Overview

- **Product Code:** QMS
- **Device Name:** Adjunctive Open Loop Fluid Therapy Recommender
- **Regulation:** [21 CFR 870.5600](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5600)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

In combination with the general controls of the FD&C Act, the adjunctive open loop fluid therapy recommender is subject to the following special controls:

*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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233984](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QMS/K233984.md) | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | Aug 2, 2024 | SESE |
| [DEN190029](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QMS/DEN190029.md) | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences | Nov 13, 2020 | DENG |

## Top Applicants

- Edwards Lifesciences — 1 clearance
- Edwards Lifesciences, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QMS](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QMS)

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