21 CFR 880.2750 — Image Processing Device For Estimation Of External Blood Loss
General Hospital (HO) · Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices · § 880.2750
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PBZ | Image Processing Device For Estimation Of External Blood Loss | 2 | 6 | SaMD |
Special Controls
PBZ — Image Processing Device For Estimation Of External Blood Loss
In combination with the general controls of the Food, Drug & Cosmetic Act, the Image processing device for estimation of external blood loss is subject to the following special controls:
De Novo Order DEN130015
PBZ — Image Processing Device For Estimation Of External Blood Loss
*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.
eCFR
PBZ — Image Processing Device For Estimation Of External Blood Loss
(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.
Ecfr Llm
