(312 days)
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.
The Burn Resuscitation Decision Support System – Clinical (BRDSS-C) is a burn decision support software application for assisting healthcare professionals in managing fluid resuscitation of burn patients during the initial 24 - 72 hours post burn. The system provides hourly (or half-hour) fluid calculations and recommendations for patients with 20% or greater Total Body Surface Area (TBSA) burn injuries, in addition to providing users with a graphical user interface to display volume status, Intake and Output (I/O) volumes, and other relevant fluid balance information.
The provided document is a 510(k) premarket notification for the Burn Resuscitation Decision Support System - Clinical (BRDSS-C), v. 1.0. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results and acceptance criteria as would be found in a clinical trial report.
Therefore, the information requested regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not fully available within the provided text.
However, I can extract the available information and point out what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it demonstrates validation against software requirements and usability, and establishes substantial equivalence to a predicate device.
| Acceptance Criteria (based on software requirements & usability) | Reported Device Performance |
|---|---|
| Data intake validation | Passed |
| User warnings, alerts, and messages | Passed |
| User interface requirements | Passed |
| Functional requirements | Passed |
| Error handling requirements | Passed |
| Human factors usability requirements | Compliant with human factors usability requirements (demonstrated by a human factors study) |
| Software verification and validation | Passed (based on FDA's Quality System Regulation requirements under 21 CFR Part 820) |
| Clinical user validation | Passed (based on FDA's Quality System Regulation requirements under 21 CFR Part 820) |
| Intended Use & Technical Features Equivalence | Substantially equivalent to the predicate device (BRDSS - Burn Navigator) in terms of intended use and technical features; any differences do not raise new safety and effectiveness questions. |
Missing Information for this section: Specific quantitative thresholds for "passing" or "compliance" with software and usability requirements are not detailed. Performance metrics related to fluid calculation accuracy or clinical outcomes are also not provided.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "software verification and validation as well as clinical user validation" and a "human factors study." However, it does not specify the sample size for any test sets used in these validations or for the human factors study.
It also does not specify the data provenance (e.g., country of origin, retrospective/prospective) for any data used in these validation efforts.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not describe the establishment of a "ground truth" for a specific test set in the context of clinical performance, as it is a fluid resuscitation calculator and relies on an established algorithm.
For the "clinical user validation," it implies that burn care professionals were involved, but does not specify the number of experts or their qualifications used to evaluate the device. The device is "intended for use by healthcare professionals with burn care experience," suggesting that these individuals, or similar ones, would have been involved in the validation.
4. Adjudication Method for the Test Set:
Given that the document does not describe a clinical test set requiring ground truth, no adjudication method is mentioned or implied. The validation focuses on software functionality, usability, and equivalence to a predicate device running the same core algorithm.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The device is a "decision support system" providing fluid recommendations, not an imaging analysis tool typically associated with MRMC studies. The focus is on the algorithm's calculation and the software's usability and safety, not on how human readers' performance improves with or without AI assistance in interpretation.
6. Standalone Performance Study:
The document describes the BRDSS-C as a "fluid resuscitation calculator for fluid recommendations" and a "burn decision support software application." Its validation is described as: "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."
This indicates that its performance as a standalone algorithm (without human intervention in its core calculation logic) was indeed evaluated through software verification and validation testing. However, specific quantifiable metrics of this standalone performance (e.g., accuracy of fluid recommendations against a gold standard in a clinical dataset) are not provided in this summary. The evaluation focuses on whether the software correctly implements its algorithm and meets its functional and usability requirements.
7. Type of Ground Truth Used:
For the core function of the device (fluid calculations), the "ground truth" is inherently the mathematical output of the underlying burn decision support algorithm, which is the same as that used in the predicate device. The validation confirms that the software correctly implements this algorithm and provides accurate calculations based on the input.
For software validation, the "ground truth" would be the defined software requirements and specifications. For human factors validation, it would be usability standards and successful task completion by representative users. Clinical outcomes data are not mentioned as a ground truth for the device's validation in this document.
8. Sample Size for the Training Set:
The BRDSS-C uses the same burn decision support algorithm as the predicate device (BRDSS - Burn Navigator). This existing algorithm would have been developed and "trained" (in a broader sense, meaning its parameters and logic established) prior to the development of the BRDSS-C.
The document does not specify a sample size for a training set used to develop or re-train the algorithm for BRDSS-C, as it states the algorithm itself is the same.
9. How the Ground Truth for the Training Set Was Established:
Since BRDSS-C utilizes an existing algorithm from its predicate, the document does not describe how a "ground truth" for a new "training set" was established for the BRDSS-C specifically.
The original algorithm (used by both BRDSS and BRDSS-C) would have been developed based on medical knowledge, clinical guidelines for burn fluid resuscitation (e.g., Parkland formula variations), and potentially validated against historical patient data or expert consensus in its initial inception. However, this information is not detailed in the provided 510(k) summary for BRDSS-C.
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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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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, PhDPrincipal Assistant for AcquisitionU.S. Army Medical Research and Materiel Command (USAMRMC)1430 Veterans DriveFort Detrick, MD 21702-5009 |
| Primary Contact: | Robert E. Miller, PhD, RACDivision of Regulated Activities and Compliance1430 Veterans DriveFort Detrick, MD 21702-5009Telephone: 301-619-0317Fax: 301-619-0197Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil |
| Secondary Contact: | Patricia Beverly, RACDivision of Regulated Activities and Compliance1430 Veterans DriveFort Detrick, MD 21702-5009Telephone: 301-619-0317Fax: 301-619-0197Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil |
| Manufacturer: | Jose Salinas, PhDBurn Intensive Care Unit, U.S. Army Burn CenterU.S. Army Institute of Surgical Research3698 Chambers PassJoint Base San Antonio, Fort Sam Houston, TX 78234-6315Telephone: 210-916-3301Fax: 210-271-0830 |
| Date Prepared: | 17 December 2014 |
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| Trade Name: | Burn Resuscitation Decision Support System - Clinical (BRDSS-C),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: | K121659Burn Resuscitation Decision Support System (BRDSS) |
| Device Description: | The Burn Resuscitation Decision Support System – Clinical(BRDSS-C) is a burn decision support software application forassisting healthcare professionals in managing fluid resuscitation ofburn patients during the initial 24 - 72 hours post burn. The systemprovides hourly (or half-hour) fluid calculations andrecommendations for patients with 20% or greater Total BodySurface Area (TBSA) burn injuries, in addition to providing userswith a graphical user interface to display volume status, Intake andOutput (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.
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| Predicate DeviceK121659BRDSS (Burn Navigator) | Burn Resuscitation Decision SupportSystem - Clinical, v. 1.0(BRDSS-C) | |
|---|---|---|
| Device Description | The BRDSS (Burn Navigator)is a tablet computer containingthe burn decision supportalgorithm for use by healthcareprofessionals in managingfluid resuscitation of burnpatients during the initial 24 -72 hours post burn. | The Burn Resuscitation Decision SupportSystem – Clinical (BRDSS-C) is a burndecision support algorithm available on aserver for use on a desktop computer byhealthcare professionals in managing fluidresuscitation of burn patients during theinitial 24 - 72 hours post burn. The BRDSS-C algorithm is the same algorithm containedin the BRDSS (Navigator). |
| BRDSS (Burn Navigator) is anhourly fluid calculator forpatients with 20% or moreTBSA burn injuries | BRDSS-C is an hourly (or half-hour) fluidcalculator for patients with 20% or moreTBSA burn injuries. | |
| DisplayedInformation | BRDSS (Burn Navigator)provides users with a graphicaluser interface to displayvolume status, Intake andOutput (I/O) volumes andother relevant fluid balanceinformation. | |
| Software-Based | Yes | Yes |
| Information Storage | BRDSS (Burn Navigator)stores information on multipleburn patients but allowsresuscitation of only onepatient at a time. | BRDSS-C stores information on multipleburn patients but allows resuscitation of onlyone patient at a time. |
| Indications for Use | BRDSS (Burn Navigator) isindicated for use in the care ofadult patients weighing 40 kgor more with 20% or moreTBSA burned, as a fluidresuscitation calculator forhourly fluidrecommendations: it is notintended for pediatric use.The BRDSS (Burn Navigator)is intended to be initiatedwithin 24 hours of the burnincident and completed by72 hours post burn. | BRDSS-C is indicated for use in the care ofadult patients and adolescent patients 17years of age or older who weigh 44kg (88lbs)or more with 20% or more TBSA burned, asa fluid resuscitation calculator for hourly (orhalf-hour) fluid recommendations. TheBRDSS-C is intended to be initiated within24 hours of the burn incident and completedby 72 hours post burn. The BRDSS-C is notindicated for use in patients who are less than17 years of age. |
| Predicate DeviceK121659BRDSS(Burn Navigator) | Burn Resuscitation Decision SupportSystem - Clinical, v 1.0(BRDSS-C) | |
| Intended User | Healthcare professional | Healthcare professional |
| Intended UseEnvironment | Hospital critical care facility ortransport vehicle | Hospital critical care facility |
| Human Factors | Physician or nurse enterspatient weight, % of bodysurface area burned and timeof burn. Warnings arepresented when the primaryfluid rate recommendation is ±25% (and ± 200mL/hr.) fromthe current primary fluid rate.In addition, graphs areincluded to show thecumulative volume of fluidsreceived and urine output. | Nurse enters patient weight, % of bodysurface area burned and time of burn.Warnings are presented when the primaryfluid rate recommendation is ± 25% from thecurrent primary fluid rate. In addition, graphsare included to show the cumulative volumeof fluids received and urine output.Connection to Essentris® also provides vitalsigns and laboratory and clinical data fordisplay. |
| Rate Calculation | Yes | Yes |
Table 1 Comparison of Technological Characteristics
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Table 2 Summary of Device Differences
| Predicate DeviceK121659BRDSS (BurnNavigator) | Burn Resuscitation DecisionSupport System - Clinical, v.1.0(BRDSS-C) | Impact on Safety and Effectiveness |
|---|---|---|
| Table computer | Desktop computer | Safety and effectiveness are not bound by thephysical device. System validation provessystem effectiveness. |
| Hardware-specificmedical device | Software medical device | Safety and effectiveness are not bound by thephysical device. System validation provessystem effectiveness. |
| Touch screen | Input devices are keyboard andmouse | Input devices have no change to systemfunctionality dealing with patient safety orsystem effectiveness. |
| Device is an all-inclusive unit | Application requiresinstallation onto an existingcomputer network | System effectiveness is not determined bythe physical device. |
| Records data to thetablet hard drive | Data are saved in Oracledatabase | Oracle is a proven product with tools fordatabase management and proven encryptionfor data security. |
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| Predicate DeviceK121659BRDSS (BurnNavigator) | Burn Resuscitation DecisionSupport System - Clinical, v.1.0(BRDSS-C) | Impact on Safety and Effectiveness |
|---|---|---|
| Intended for use bymedical staff, but notnecessarily staff withburn care experience. | Intended for use by healthcareprofessionals with burn careexperience. | Use by experienced burn unit healthcareproviders adds a layer of safety to the device.System validation proves systemeffectiveness. |
| Not intended for usein pediatric patients. | Intended for use in patients 17years of age or older. Patientswho are 21 years of age oryounger at the time ofdiagnosis or care are pediatricpatients (21CFR814.3). | Use of either device is restricted to patientswho weigh 44kg or more. Use either devicein older adolescent patients will not affect thesafety and effectiveness of the device. |
| N/A | Requires User Manager foruser access (User Managermust be installed and theBRDSS-C user added andconfigured correctly before theuser can access BRDSS-C.)The DOD Common AccessCard (CAC) is used for system(desktop) and BRDSS-Capplication access. UserManager is configured to useCAC credentials. | Additional security for user access makes thesystem more secure. No change to systemfunctionality dealing with patient safety orsystem 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.
§ 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).