Burn Resuscitation Decision Support Software
The Burn Resuscitation Decision Support Software is an anesthesiology clinical decision support device intended to predict hourly fluid volume requirements during initial resuscitation of burn patients, providing guidance to clinicians managing fluid therapy in the critical early phase of burn care. It falls under the Anesthesiology medical specialty and is classified as a Class 2 device under regulation 868.1890, requiring 510(k) premarket notification. This software aims to improve the accuracy of fluid resuscitation and reduce complications in severely burned patients. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PDT
- Device Class
- FDA class 2
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140387 | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) | Dec 23, 2014 | Substantially Equivalent | The Surgeon General, Department of the Army |
| K121659 | BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) | Apr 18, 2013 | Substantially Equivalent | Arcos, Inc. |