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Burn Resuscitation Decision Support Software

Page Type
Product Code
Definition
The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.
Physical State
Software that is accessed through hardware that provides user interface through screen displays.
Technical Method
BRDSS is a software based calculator that uses an algorithm to calculate resuscitation volume using physiological data inputs. The algorithm used is developed by the manufacturer and may not be the typical algorithm used in standard practice to calculate fluid management for burn patients.
Target Area
None. The fluid volume calculated by the software will affect systemic, total body fluid homeostasis.
Regulation Medical Specialty
Anesthesiology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1890
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1890 Predictive pulmonary-function value calculator

§ 868.1890 Predictive pulmonary-function value calculator.

(a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

(b) Classification. Class II (performance standards).

Burn Resuscitation Decision Support Software

Page Type
Product Code
Definition
The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.
Physical State
Software that is accessed through hardware that provides user interface through screen displays.
Technical Method
BRDSS is a software based calculator that uses an algorithm to calculate resuscitation volume using physiological data inputs. The algorithm used is developed by the manufacturer and may not be the typical algorithm used in standard practice to calculate fluid management for burn patients.
Target Area
None. The fluid volume calculated by the software will affect systemic, total body fluid homeostasis.
Regulation Medical Specialty
Anesthesiology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1890
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1890 Predictive pulmonary-function value calculator

§ 868.1890 Predictive pulmonary-function value calculator.

(a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

(b) Classification. Class II (performance standards).