(317 days)
The Burn Resuscitation Decision Support System (BRDSS) is indicated for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for hourly fluid recommendations. The BRDSS is intended to be initiated within 24 hours of the burn incident and ending by 72 hours post burn.
The BRDSS is a fluid calculator for use in the care of seriously burned patients. It is used to calculate the next dose of fluid for patients.
Device: Burn Resuscitation Decision Support System (BRDSS)
The provided documentation is a 510(k) summary for the Burn Resuscitation Decision Support System (BRDSS). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a dedicated study proving performance against those criteria, or the methodology for establishing ground truth or training a model.
Therefore, I can only extract limited information based on the available text.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as a quantitative threshold or target. Instead, it states that the BRDSS "has passed product verification as well as clinical user validation." This implies that the device successfully met internal testing standards and was deemed acceptable by clinical users, but the specific metrics are not disclosed.
The "performance" described relates to its functionality and human factors, rather than a formal assessment of accuracy against a gold standard for fluid resuscitation recommendations.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from "Non-Clinical Data") |
|---|---|
| Hardware Requirements Met | Adheres to hardware requirements (e.g., form factor, power requirements). |
| Software Requirements Met | Adheres to software requirements (e.g., data input validation, user warnings, alerts and messages, user interface requirements, functional requirements, error handling requirements). Includes many human factors best practices for the software user interface. |
| Product Verification | Passed product verification. (Specific tests and metrics not detailed) |
| Clinical User Validation | Passed clinical user validation. (Specific methodology, number of users, and outcomes not detailed) |
| Warnings for Fluid Rate Deviation | Warnings are presented when the primary fluid rate recommendation is +/- 25% (and +/- 200mL/hr) from the current primary fluid rate dose. (This is a design feature, not an external acceptance criterion against a gold standard.) |
| Ability to Calculate Hourly Fluid Recommendations | The device is a "fluid resuscitation calculator for hourly fluid recommendations." (The accuracy of these recommendations against a medical gold standard is not explicitly detailed as part of the acceptance criteria beyond general "verification" and "validation.") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide a specific sample size for a test set or details about data provenance (e.g., country of origin, retrospective/prospective). The statement "passed product verification as well as clinical user validation" suggests some form of testing, but the nature of this testing (clinical data-based evaluation vs. software testing) and its dataset characteristics are not described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for a test set. The validation appears to be related to software functionality and user experience, rather than comparing the BRDSS's fluid recommendations against expert-determined optimal fluid recommendations for a cohort of patients.
4. Adjudication Method for the Test Set
Since no specific test set based on patient data for which a ground truth needed to be established is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study. The BRDSS is a "decision support system" or "calculator," which implies it provides recommendations based on predefined algorithms rather than interpreting complex medical images or data that typically require multiple human readers. Its primary predicate device is also a "next-dose calculator." Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable or relevant for this type of device based on the information provided.
6. Standalone (Algorithm Only) Performance Study
The document states, "The BRDSS has passed product verification as well as clinical user validation." This implies that the algorithm's performance (i.e., its ability to correctly calculate fluid recommendations based on its internal logic and inputs) was tested. However, the exact details of this standalone performance, such as accuracy metrics or comparison against a gold standard for fluid resuscitation outcomes, are not provided. The "Non-Clinical Data" section focuses on hardware, software, and human factors requirements, suggesting internal functional testing.
7. Type of Ground Truth Used
Given the nature of the device as a "fluid resuscitation calculator," the "ground truth" would ideally be expert consensus on optimal fluid calculations or actual patient outcomes related to fluid management. However, the document does not specify what type of ground truth was used during its "product verification" or "clinical user validation." It is most likely that the "ground truth" for verification involved comparing the BRDSS's calculated fluid recommendations against a pre-defined, accepted medical formula or protocol for burn resuscitation (e.g., Parkland formula variations), rather than actual patient outcomes or a panel of experts retrospectively determining the "correct" dose for each case.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The BRDSS appears to be a rule-based calculator rather than a machine learning model that requires a distinct training phase. Its operation is based on established medical formulas for fluid resuscitation in burn patients.
9. How the Ground Truth for the Training Set Was Established
As the device appears to be a rule-based system and does not mention a training set, there is no information on how a ground truth for a training set was established.
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Arcos
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Burn Resuscitation Decision Support System 510(k) Summary
APR 1 8 2013
| Submitted by: | Arcos, Inc.866 W. 41st St.Houston, TX 77018 |
|---|---|
| Contact: | Chris Meador713-397-3030 |
| Date Prepared: | May 25, 2012 |
| Product Trade Name: | Burn Resuscitation Decision Support System (BRDSS) |
| Common Name: | Drug Calculator |
| Classification: | Class II |
| Classification Name: | 21 CFR 868.1890, Predictive Pulmonary-function valuecalculator. Product Code: PDT |
| Predicate Device: | K011571, TRxF Intelligent Dosing System™ |
| Device Description: | The BRDSS is a fluid calculator for use in the care ofseriously burned patients. It is used to calculate the nextdose of fluid for patients. |
Indications For Use
The Burn Resuscitation Decision Support System (BRDSS) is indicated for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned as a fluid resuscitation calculator for hourly fluid recommendations. The BRDSS is intended to be initiated within 24 hours of the burn.
· Substantial Equivalence
A. Predicate Device Comparison
| Predicate DeviceK011571TRxF Intelligent DosingSystem™ | ApplicantBurn Resuscitation Decision SupportSystem (BRDSS) | |
|---|---|---|
| DeviceDescription | The IDS™ is a next-dosecalculator for any drugthat can be used byphysicians to calculate thenext dose for patients. | The BRDSS is a fluid calculator for use inthe care of seriously burned patients. It isused to calculate the next dose of fluid forpatients. |
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| Intended Use | The IDS is a software-based drug-dosingcalculator designed for useby the physician tocalculate the next dose ofany drug to achieve adesired target. | The Burn Resuscitation Decision SupportSystem (BRDSS) is indicated for use inthe care of adult patients with 20% ormore Total Body Surface Area (TBSA)burned, as a fluid resuscitation calculatorfor hourly fluid recommendations. TheBRDSS is intended to be initiated within24 hours of the burn incident and endingby 72 hours post burn. |
|---|---|---|
| Intended User | Healthcare professional | Healthcare professional |
| Intended UseEnvironment | Health care facility | Hospital critical-care environment |
| HumanFactors | Physician enters patient'sglucose values andamounts of insulin.Warnings are presentedwhen values are out ofrange and /or insulin dosesare greater than or lessthan 20% of the mostrecent dose. | Physician or nurse enters patient weight,% of body surface area burned and time ofburn. Warnings are presented when theprimary fluid rate recommendation is +/-25% (and +/- 200mL/hr) from the currentprimary fluid rate dose. In addition,graphs are included to show patient'scumulative volume of fluids received andhourly fluids in and urine out. |
| Software-BasedDoseCalculation | Yes | Yes |
B. Non-Clinical Data
The BRDSS adheres to hardware requirements, such as form factor and power requirements, as well as software requirements, such as data input validation, user warnings, alerts and messages, user interface requirements, functional requirements and error handling requirements. The BRDSS includes many human factors best practices for the software user interface.
The BRDSS has passed product verification as well as clinical user validation.
Substantial Equivalence
The BRDSS and the predicate device, the TRxF Intelligent Dosing System, are both portable software-based systems that allow the healthcare professional to calculate dosages of either medicines or fluids to a patient. Both devices provide dose calculations based on relevant patient clinical data. The indications for use are very similar, and the technological and human factors features are essentially identical.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2013
Arcos, Incorporated % Mr. Chris Meador 866 West 41st Street Houston, Texas 77018
Re: K121659
Trade/Device Name: Burn Resuscitation Decision Support Software (BRDSS) Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: PDT Dated: February 28, 2013 Received: March 04, 2013
Dear Mr. Meador:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Chris Meador
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours, FOR
Peter D
Mark N. Melkerson Acting 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):
1121659
Device Name:
Burn Resuscitation Decision Support System (BRDSS)
Indications for Use:
The Burn Resuscitation Decision Support System (BRDSS) is indicated for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for hourly fluid recommendations. The BRDSS is intended to be initiated within 24 hours of the burn incident and ending by 72 hours post burn.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JiyoungDang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K121659
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§ 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).