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.
| Device Type ID | 5447 |
| Device Name | Burn Resuscitation Decision Support Software |
| 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 Calcu |
| Target Area | None. The Fluid Volume Calculated By The Software Will Affect Systemic, Total Body Fluid Homeostasis. |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5447 |
| Device | Burn Resuscitation Decision Support Software |
| Product Code | PDT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| CFR Regulation Number | 868.1890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |