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Image Processing Device For Estimation Of External Blood Loss

Page Type
Product Code
Definition
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.
Physical State
Software and Hardware system.
Technical Method
A software algorithm analyzes recorded images of surgical sponges to estimate hemoglobin mass.
Target Area
General Surgery
Regulation Medical Specialty
General Hospital
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.2750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.2750 Image processing device for estimation of external blood loss

§ 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.

[82 FR 60307, Dec. 20, 2017]

Image Processing Device For Estimation Of External Blood Loss

Page Type
Product Code
Definition
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.
Physical State
Software and Hardware system.
Technical Method
A software algorithm analyzes recorded images of surgical sponges to estimate hemoglobin mass.
Target Area
General Surgery
Regulation Medical Specialty
General Hospital
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.2750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.2750 Image processing device for estimation of external blood loss

§ 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.

[82 FR 60307, Dec. 20, 2017]