- (a) Identification. An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Demonstration of the performance characteristics must include a comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass. The following use conditions must be tested:
- (i) Lighting conditions;
- (ii) Range of expected hemoglobin concentrations;
- (iii) Range of expected blood volume absorption; and
- (iv) Presence of other non-sanguineous fluids (e.g., saline irrigation fluid).
- (2) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by intended users of the device.
- (3) Appropriate analysis and non-clinical testing must validate the electromagnetic compatibility (EMC) and wireless performance of the device.
- (4) Appropriate software verification, validation, and hazard analysis must be performed.
- (5) Software display must include an estimate of the cumulative error associated with estimated blood loss values.
(6) Labeling must include:
- (i) Warnings, cautions, and limitations needed for safe use of the device;
- (ii) A detailed summary of the performance testing pertinent to use of the device, including a description of the bias and variance the device exhibited during testing;
- (iii) The validated surgical materials, range of hemoglobin mass, software, hardware, and accessories that the device is intended to be used with; and
- (iv) EMC and wireless technology instructions and information.
[82 FR 60307, Dec. 20, 2017]