Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 23, 2014 The Surgeon General, Department of the Army Dr. Kenneth A. Bertram Principal Assistant for Acquisition 1430 Veterans Drive Fort Detrick, Maryland 21702 Re: K140387 Trade/Device Name: Burn Resuscitation Decision Support System -Clinical (BRDSS-C), v. 1.0 Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: PDT Dated: November 24, 2014 Received: November 25, 2014 Dear Dr. Bertram: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 {1}------------------------------------------------ ## Page 2 - Dr. Kenneth A. Bertram CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K140387 #### Device Name Burn Resuscitation Decision Support System - Clinical (BRDSS-C), v. 1.0 Indications for Use (Describe) The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # BURN RESUSCITATION DECISION SUPPORT SYSTEM - CLINICAL (BRDSS-C), v. 1.0 | Submitted by: | Office of Surgeon General, Department of Army | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor's Representative | Kenneth A. Bertram, MD, PhD<br>Principal Assistant for Acquisition<br>U.S. Army Medical Research and Materiel Command (USAMRMC)<br>1430 Veterans Drive<br>Fort Detrick, MD 21702-5009 | | Primary Contact: | Robert E. Miller, PhD, RAC<br>Division of Regulated Activities and Compliance<br>1430 Veterans Drive<br>Fort Detrick, MD 21702-5009<br>Telephone: 301-619-0317<br>Fax: 301-619-0197<br>Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-<br>affairs@mail.mil | | Secondary Contact: | Patricia Beverly, RAC<br>Division of Regulated Activities and Compliance<br>1430 Veterans Drive<br>Fort Detrick, MD 21702-5009<br>Telephone: 301-619-0317<br>Fax: 301-619-0197<br>Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-<br>affairs@mail.mil | | Manufacturer: | Jose Salinas, PhD<br>Burn Intensive Care Unit, U.S. Army Burn Center<br>U.S. Army Institute of Surgical Research<br>3698 Chambers Pass<br>Joint Base San Antonio, Fort Sam Houston, TX 78234-6315<br>Telephone: 210-916-3301<br>Fax: 210-271-0830 | | Date Prepared: | 17 December 2014 | {4}------------------------------------------------ | Trade Name: | Burn Resuscitation Decision Support System - Clinical (BRDSS-C),<br>v. 1.0 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Software-based fluid volume calculator | | Regulation Number: | 21 CFR 868.1890 | | Classification Name: | Predictive pulmonary-function value calculator. | | Regulatory Class | Class II | | Product Code: | PDT | | Predicate Device: | K121659<br>Burn Resuscitation Decision Support System (BRDSS) | | Device Description: | The Burn Resuscitation Decision Support System – Clinical<br>(BRDSS-C) is a burn decision support software application for<br>assisting healthcare professionals in managing fluid resuscitation of<br>burn patients during the initial 24 - 72 hours post burn. The system<br>provides hourly (or half-hour) fluid calculations and<br>recommendations for patients with 20% or greater Total Body<br>Surface Area (TBSA) burn injuries, in addition to providing users<br>with a graphical user interface to display volume status, Intake and<br>Output (I/O) volumes, and other relevant fluid balance information. | #### Indications for Use The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age. #### Predicate Device Comparison The predicate device, Burn Resuscitation Decision Support System (BRDSS), is now known as the BRDSS (Burn Navigator) by Arcos™ (Houston, TX). Therefore, the predicate device will be referred to as BRDSS (Burn Navigator) throughout this 510(k). Table 1 presents a summary comparison of the technological characteristics of predicate device and the BRDSS-C. Table 2 summarizes the differences in physical/technological characteristics and intended use statements between the two devices. {5}------------------------------------------------ | | Predicate Device<br>K121659<br>BRDSS (Burn Navigator) | Burn Resuscitation Decision Support<br>System - Clinical, v. 1.0<br>(BRDSS-C) | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description | The BRDSS (Burn Navigator)<br>is a tablet computer containing<br>the burn decision support<br>algorithm for use by healthcare<br>professionals in managing<br>fluid resuscitation of burn<br>patients during the initial 24 -<br>72 hours post burn. | The Burn Resuscitation Decision Support<br>System – Clinical (BRDSS-C) is a burn<br>decision support algorithm available on a<br>server for use on a desktop computer by<br>healthcare professionals in managing fluid<br>resuscitation of burn patients during the<br>initial 24 - 72 hours post burn. The BRDSS-<br>C algorithm is the same algorithm contained<br>in the BRDSS (Navigator). | | | BRDSS (Burn Navigator) is an<br>hourly fluid calculator for<br>patients with 20% or more<br>TBSA burn injuries | BRDSS-C is an hourly (or half-hour) fluid<br>calculator for patients with 20% or more<br>TBSA burn injuries. | | | Displayed<br>Information | BRDSS (Burn Navigator)<br>provides users with a graphical<br>user interface to display<br>volume status, Intake and<br>Output (I/O) volumes and<br>other relevant fluid balance<br>information. | | Software-Based | Yes | Yes | | Information Storage | BRDSS (Burn Navigator)<br>stores information on multiple<br>burn patients but allows<br>resuscitation of only one<br>patient at a time. | BRDSS-C stores information on multiple<br>burn patients but allows resuscitation of only<br>one patient at a time. | | Indications for Use | BRDSS (Burn Navigator) is<br>indicated for use in the care of<br>adult patients weighing 40 kg<br>or more with 20% or more<br>TBSA burned, as a fluid<br>resuscitation calculator for<br>hourly fluid<br>recommendations: it is not<br>intended for pediatric use.<br>The BRDSS (Burn Navigator)<br>is intended to be initiated<br>within 24 hours of the burn<br>incident and completed by<br>72 hours post burn. | BRDSS-C is indicated for use in the care of<br>adult patients and adolescent patients 17<br>years of age or older who weigh 44kg (88lbs)<br>or more with 20% or more TBSA burned, as<br>a fluid resuscitation calculator for hourly (or<br>half-hour) fluid recommendations. The<br>BRDSS-C is intended to be initiated within<br>24 hours of the burn incident and completed<br>by 72 hours post burn. The BRDSS-C is not<br>indicated for use in patients who are less than<br>17 years of age. | | | Predicate Device<br>K121659<br>BRDSS<br>(Burn Navigator) | Burn Resuscitation Decision Support<br>System - Clinical, v 1.0<br>(BRDSS-C) | | Intended User | Healthcare professional | Healthcare professional | | Intended Use<br>Environment | Hospital critical care facility or<br>transport vehicle | Hospital critical care facility | | Human Factors | Physician or nurse enters<br>patient weight, % of body<br>surface area burned and time<br>of burn. Warnings are<br>presented when the primary<br>fluid rate recommendation is ±<br>25% (and ± 200mL/hr.) from<br>the current primary fluid rate.<br>In addition, graphs are<br>included to show the<br>cumulative volume of fluids<br>received and urine output. | Nurse enters patient weight, % of body<br>surface area burned and time of burn.<br>Warnings are presented when the primary<br>fluid rate recommendation is ± 25% from the<br>current primary fluid rate. In addition, graphs<br>are included to show the cumulative volume<br>of fluids received and urine output.<br>Connection to Essentris® also provides vital<br>signs and laboratory and clinical data for<br>display. | | Rate Calculation | Yes | Yes | ## Table 1 Comparison of Technological Characteristics {6}------------------------------------------------ # Table 2 Summary of Device Differences | Predicate Device<br>K121659<br>BRDSS (Burn<br>Navigator) | Burn Resuscitation Decision<br>Support System - Clinical, v.<br>1.0<br>(BRDSS-C) | Impact on Safety and Effectiveness | |----------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Table computer | Desktop computer | Safety and effectiveness are not bound by the<br>physical device. System validation proves<br>system effectiveness. | | Hardware-specific<br>medical device | Software medical device | Safety and effectiveness are not bound by the<br>physical device. System validation proves<br>system effectiveness. | | Touch screen | Input devices are keyboard and<br>mouse | Input devices have no change to system<br>functionality dealing with patient safety or<br>system effectiveness. | | Device is an all-<br>inclusive unit | Application requires<br>installation onto an existing<br>computer network | System effectiveness is not determined by<br>the physical device. | | Records data to the<br>tablet hard drive | Data are saved in Oracle<br>database | Oracle is a proven product with tools for<br>database management and proven encryption<br>for data security. | {7}------------------------------------------------ | Predicate Device<br>K121659<br>BRDSS (Burn<br>Navigator) | Burn Resuscitation Decision<br>Support System - Clinical, v.<br>1.0<br>(BRDSS-C) | Impact on Safety and Effectiveness | |--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended for use by<br>medical staff, but not<br>necessarily staff with<br>burn care experience. | Intended for use by healthcare<br>professionals with burn care<br>experience. | Use by experienced burn unit healthcare<br>providers adds a layer of safety to the device.<br>System validation proves system<br>effectiveness. | | Not intended for use<br>in pediatric patients. | Intended for use in patients 17<br>years of age or older. Patients<br>who are 21 years of age or<br>younger at the time of<br>diagnosis or care are pediatric<br>patients (21CFR814.3). | Use of either device is restricted to patients<br>who weigh 44kg or more. Use either device<br>in older adolescent patients will not affect the<br>safety and effectiveness of the device. | | N/A | Requires User Manager for<br>user access (User Manager<br>must be installed and the<br>BRDSS-C user added and<br>configured correctly before the<br>user can access BRDSS-C.)<br>The DOD Common Access<br>Card (CAC) is used for system<br>(desktop) and BRDSS-C<br>application access. User<br>Manager is configured to use<br>CAC credentials. | Additional security for user access makes the<br>system more secure. No change to system<br>functionality dealing with patient safety or<br>system effectiveness. | ## Non-clinical Performance Data The BRDSS-C adheres to software requirements such as data intake validation, user warnings, alerts and messages, user interface requirements, functional requirements and error handling requirements. A human factors study was conducted and demonstrated that the software is compliant with human factors usability requirements. The BRDSS-C has passed software verification and validation as well as clinical user validation based on the FDA's Quality System Regulation requirements under 21 CFR Part 820. ## Substantial Equivalence BRDSS-C and the predicate device, BRDSS (Burn Navigator), are both software-based fluid calculators intended to be used by healthcare professionals to calculate resuscitation fluid volumes for burn patients during the initial 24 - 72 hours post burn. Both devices provide rate calculations based on the same burn decision support algorithm using patient physical (e.g. TBSA and body weight) and clinical data (e.g. intravenous fluid infused). The BRDSS (Burn Navigator) is operated on a tablet computer and the BRDSS-C is operated from a standard desktop computer. Physical differences between the two devices do not affect the burn decision support algorithm. Both devices are not intended for use in patients who weigh less than 44kg (88lbs). Based upon the above information, the BRDSS-C is substantially equivalent to the predicate device in terms of intended use and technical features; any differences do not raise new safety and effectiveness questions.