Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 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.
[89 FR 72319, Sept. 5, 2024]