(317 days)
Not Found
No
The summary describes a fluid calculator based on TBSA, which is a standard burn care calculation. There is no mention of AI, ML, or any learning algorithms.
No.
The BRDSS is a fluid resuscitation calculator and decision support system; it does not directly treat a disease or condition, but rather assists healthcare professionals in making treatment decisions.
No
Explanation: The device is a fluid resuscitation calculator and does not provide a diagnosis. It helps in managing already diagnosed burn patients by calculating fluid recommendations.
Yes
The description focuses solely on the software's function as a fluid calculator and decision support system. There is no mention of any accompanying hardware components or hardware-specific functionalities beyond the software's calculation and recommendation capabilities. The predicate device is also a "Dosing System," suggesting a software-centric function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BRDSS Function: The BRDSS is described as a "fluid resuscitation calculator for hourly fluid recommendations" and a "fluid calculator for use in the care of seriously burned patients." It uses patient data (TBSA burned, time since burn) to calculate fluid recommendations.
- Lack of Sample Analysis: There is no mention of the BRDSS analyzing any biological samples from the patient. Its function is based on calculations derived from patient characteristics and time.
Therefore, the BRDSS falls outside the scope of an In Vitro Diagnostic device. It is a clinical decision support tool that assists healthcare professionals in managing fluid resuscitation for burn patients.
N/A
Intended Use / 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.
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.
Product codes
PDT
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Intended User: Healthcare professional
Intended Use Environment: Hospital critical-care environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Arcos
$\rho^{1/2}$
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 Meador
713-397-3030 |
| 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 value
calculator. Product Code: PDT |
| Predicate Device: | K011571, TRxF Intelligent Dosing System™ |
| Device Description: | 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. |
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 Device
K011571
TRxF Intelligent Dosing
System™ | Applicant
Burn Resuscitation Decision Support
System (BRDSS) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The IDS™ is a next-dose
calculator for any drug
that can be used by
physicians to calculate the
next dose for patients. | 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. |
1
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| Intended Use | The IDS is a software-
based drug-dosing
calculator designed for use
by the physician to
calculate the next dose of
any drug to achieve a
desired target. | 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. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended User | Healthcare professional | Healthcare professional |
| Intended Use
Environment | Health care facility | Hospital critical-care environment |
| Human
Factors | Physician enters patient's
glucose values and
amounts of insulin.
Warnings are presented
when values are out of
range and /or insulin doses
are greater than or less
than 20% of the most
recent dose. | Physician or nurse enters patient weight,
% of body surface area burned and time of
burn. Warnings are presented when the
primary fluid rate recommendation is +/-
25% (and +/- 200mL/hr) from the current
primary fluid rate dose. In addition,
graphs are included to show patient's
cumulative volume of fluids received and
hourly fluids in and urine out. |
| Software-
Based
Dose
Calculation | 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.
2
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
3
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
4
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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