21 CFR 868.5896 — Ventilator Waveform Analysis Software
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5896
Identification
Syncron-E is a computer program (software) intended as an adjunctive aid for detecting evidence of ineffective efforts during exhalation and rest periods in previously recorded mechanical ventilation waveform data obtained while in volume control ventilation (VCV), pressure control ventilation (PCV), or pressure support ventilation (PSV) modes. It is intended for respiratory therapists to analyze 30 to 60 minutes of previously recorded ventilator waveform data per analysis session for adult patients 22 years and older receiving invasive ventilation.
Classification Rationale
Class II (special controls). FDA has determined that the device can be classified in class II with the establishment of special controls to provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QVC | Ventilator Waveform Analysis Software | 2 | 1 | SaMD |
Special Controls
QVC — Ventilator Waveform Analysis Software
In combination with the general controls of the FD&C Act, the ventilator waveform analysis software is subject to the following special controls: (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must fulfill the following: (i) Device output must be compared against a clinically justified reference standard (e.g., ground truth established by expert adjudication); (ii) Agreement with the reference standard must be assessed across the clinically relevant range using performance metrics relevant to the device output; (iii) The clinical dataset must be representative of the intended use population and relevant clinical parameters (e.g., ventilation modes) and include all compatible ventilator models. Any data selection criteria or limitations must be fully described and justified; and (iv) Testing must use a dataset that is independent and distinct from the data used for training or development of the software algorithm(s). (2) Software verification, validation, and hazard analysis must be provided. Software documentation must include: (i) Compatibility testing validating device performance with all compatible ventilators labeled to be compatible with the device; (ii) A description of the algorithm(s) used to analyze the data, including inputs and outputs, algorithm logic and related technical parameters, and criteria for excluding data from analysis; and (iii) Information regarding the dataset used to develop the algorithm(s), including the population studied and relevant clinical characteristics (ventilation modes and ventilator models). (3) Human factors and usability testing must demonstrate the following: (i) The intended user(s) can correctly use the device and interpret the device output based solely on the directions for use and labeling; and (ii) Testing must be conducted in the intended use environment and inclusive of worst-case simulated use conditions to ensure compatibility with clinical workflows. (4) Labeling must include: (i) A detailed summary of the device's technical parameters; (ii) A listing of compatible ventilator models and versions, ventilation modes, and associated settings; (iii) A summary of the clinical performance testing conducted with the device; (iv) A description of situations in which the device may fail or may not operate at its expected performance level (e.g., extreme ventilator settings or specific patient populations); and (v) A warning against overreliance on device output.
De Novo Order DEN250025
