part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
subpart_code: "C"
subpart_subject: "General Hospital and Personal Use Monitoring Devices"
section_number: "880.2750"
section_subject: "Image processing device for estimation of external blood loss."
cfr_reference: "21 CFR 880.2750"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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:
(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.
(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.