---
kind: "section"
citation: "21 C.F.R. § 870.5600"
title: "21"
number: "870.5600"
heading: "Adjunctive open loop fluid therapy recommender."
url: "https://uscodex.org/cfr/21/870.5600"
---

# §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.

## Notes

### Amendments

[89 FR 72319, Sept. 5, 2024]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[89 FR 72319, Sept. 5, 2024]