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U.S. Department of Health and Human Services

Product Classification

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Device burn resuscitation decision support software
Regulation Description Predictive pulmonary-function value calculator.
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 & Plastic Surgery
Product CodePDT
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 868.1890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons