(312 days)
Not Found
No
The summary describes a software application for fluid resuscitation calculations and decision support, but there is no mention of AI or ML technologies being used in the device description or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a decision support software application that provides fluid recommendations and calculations. It does not actively deliver or administer any therapy.
No
The device is a fluid resuscitation calculator and decision support software, which provides recommendations based on calculations, rather than diagnosing a medical condition.
Yes
The device description explicitly states it is a "burn decision support software application" and there is no mention of any accompanying hardware components. The performance studies focus on software verification and validation and human factors usability, further supporting its software-only nature.
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.
- Device Function: The BRDSS-C is a software application that acts as a fluid resuscitation calculator and decision support system. It uses patient information (like TBSA burn) to provide fluid recommendations. It does not analyze biological samples.
- Intended Use: The intended use is to assist healthcare professionals in managing fluid resuscitation, not to diagnose or detect a condition based on in vitro analysis.
Therefore, the BRDSS-C falls under the category of a clinical decision support system or medical software, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
PDT
Device Description
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.
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 and adolescent patients 17 years of age or older.
Not indicated for use in patients who are less than 17 years of age.
Intended User / Care Setting
Healthcare professional, Hospital critical care facility
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)
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.
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
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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
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| Principal Assistant for Acquisition | |
| U.S. Army Medical Research and Materiel Command (USAMRMC) | |
| 1430 Veterans Drive | |
| Fort Detrick, MD 21702-5009 | |
| Primary Contact: | Robert E. Miller, PhD, RAC |
| Division of Regulated Activities and Compliance | |
| 1430 Veterans Drive | |
| Fort Detrick, MD 21702-5009 | |
| Telephone: 301-619-0317 | |
| Fax: 301-619-0197 | |
| Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory- | |
| affairs@mail.mil | |
| Secondary Contact: | Patricia Beverly, RAC |
| Division of Regulated Activities and Compliance | |
| 1430 Veterans Drive | |
| Fort Detrick, MD 21702-5009 | |
| Telephone: 301-619-0317 | |
| Fax: 301-619-0197 | |
| Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory- | |
| affairs@mail.mil | |
| Manufacturer: | Jose Salinas, PhD |
| Burn Intensive Care Unit, U.S. Army Burn Center | |
| U.S. Army Institute of Surgical Research | |
| 3698 Chambers Pass | |
| Joint Base San Antonio, Fort Sam Houston, TX 78234-6315 | |
| Telephone: 210-916-3301 | |
| Fax: 210-271-0830 | |
| Date Prepared: | 17 December 2014 |
4
| 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: | K121659
Burn Resuscitation Decision Support System (BRDSS) |
| Device Description: | 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. |
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
K121659
BRDSS (Burn Navigator) | Burn Resuscitation Decision Support
System - Clinical, v. 1.0
(BRDSS-C) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The BRDSS (Burn Navigator)
is a tablet computer containing
the burn decision support
algorithm for use by healthcare
professionals in managing
fluid resuscitation of burn
patients during the initial 24 -
72 hours post burn. | The Burn Resuscitation Decision Support
System – Clinical (BRDSS-C) is a burn
decision support algorithm available on a
server for use on a desktop computer by
healthcare professionals in managing fluid
resuscitation of burn patients during the
initial 24 - 72 hours post burn. The BRDSS-
C algorithm is the same algorithm contained
in the BRDSS (Navigator). |
| | BRDSS (Burn Navigator) is an
hourly fluid calculator for
patients with 20% or more
TBSA burn injuries | BRDSS-C is an hourly (or half-hour) fluid
calculator for patients with 20% or more
TBSA burn injuries. |
| | Displayed
Information | BRDSS (Burn Navigator)
provides users with a graphical
user interface to display
volume status, Intake and
Output (I/O) volumes and
other relevant fluid balance
information. |
| Software-Based | Yes | Yes |
| Information Storage | BRDSS (Burn Navigator)
stores information on multiple
burn patients but allows
resuscitation of only one
patient at a time. | BRDSS-C stores information on multiple
burn patients but allows resuscitation of only
one patient at a time. |
| Indications for Use | BRDSS (Burn Navigator) is
indicated for use in the care of
adult patients weighing 40 kg
or more with 20% or more
TBSA burned, as a fluid
resuscitation calculator for
hourly fluid
recommendations: it is not
intended for pediatric use.
The BRDSS (Burn Navigator)
is intended to be initiated
within 24 hours of the burn
incident and completed by
72 hours post burn. | BRDSS-C is indicated for use in the care of
adult patients and adolescent patients 17
years of age or older who weigh 44kg (88lbs)
or more with 20% or more TBSA burned, as
a fluid resuscitation calculator for hourly (or
half-hour) 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
K121659
BRDSS
(Burn Navigator) | Burn Resuscitation Decision Support
System - Clinical, v 1.0
(BRDSS-C) |
| Intended User | Healthcare professional | Healthcare professional |
| Intended Use
Environment | Hospital critical care facility or
transport vehicle | Hospital critical care facility |
| Human Factors | 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.
In addition, graphs are
included to show the
cumulative volume of fluids
received and urine output. | Nurse enters patient weight, % of body
surface area burned and time of burn.
Warnings are presented when the primary
fluid rate recommendation is ± 25% from the
current primary fluid rate. In addition, graphs
are included to show the cumulative volume
of fluids received and urine output.
Connection to Essentris® also provides vital
signs and laboratory and clinical data for
display. |
| Rate Calculation | Yes | Yes |
Table 1 Comparison of Technological Characteristics
6
Table 2 Summary of Device Differences
| Predicate Device
K121659
BRDSS (Burn
Navigator) | Burn Resuscitation Decision
Support System - Clinical, v.
1.0
(BRDSS-C) | Impact on Safety and Effectiveness |
|----------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Table computer | Desktop computer | Safety and effectiveness are not bound by the
physical device. System validation proves
system effectiveness. |
| Hardware-specific
medical device | Software medical device | Safety and effectiveness are not bound by the
physical device. System validation proves
system effectiveness. |
| Touch screen | Input devices are keyboard and
mouse | Input devices have no change to system
functionality dealing with patient safety or
system effectiveness. |
| Device is an all-
inclusive unit | Application requires
installation onto an existing
computer network | System effectiveness is not determined by
the physical device. |
| Records data to the
tablet hard drive | Data are saved in Oracle
database | Oracle is a proven product with tools for
database management and proven encryption
for data security. |
7
| Predicate Device
K121659
BRDSS (Burn
Navigator) | Burn Resuscitation Decision
Support System - Clinical, v.
1.0
(BRDSS-C) | Impact on Safety and Effectiveness |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended for use by
medical staff, but not
necessarily staff with
burn care experience. | Intended for use by healthcare
professionals with burn care
experience. | Use by experienced burn unit healthcare
providers adds a layer of safety to the device.
System validation proves system
effectiveness. |
| Not intended for use
in pediatric patients. | Intended for use in patients 17
years of age or older. Patients
who are 21 years of age or
younger at the time of
diagnosis or care are pediatric
patients (21CFR814.3). | Use of either device is restricted to patients
who weigh 44kg or more. Use either device
in older adolescent patients will not affect the
safety and effectiveness of the device. |
| N/A | Requires User Manager for
user access (User Manager
must be installed and the
BRDSS-C user added and
configured correctly before the
user can access BRDSS-C.)
The DOD Common Access
Card (CAC) is used for system
(desktop) and BRDSS-C
application access. User
Manager is configured to use
CAC credentials. | Additional security for user access makes the
system more secure. No change to system
functionality dealing with patient safety or
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.