---
kind: "section"
citation: "21 C.F.R. § 880.2750"
title: "21"
number: "880.2750"
heading: "Image processing device for estimation of external blood loss."
url: "https://uscodex.org/cfr/21/880.2750"
---

# §880.2750. Image processing device for estimation of external blood loss.

- (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.**

## Notes

### Amendments

[82 FR 60307, Dec. 20, 2017]

### Authority

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

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[82 FR 60307, Dec. 20, 2017]