BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)

K121659 · Arcos, Inc. · PDT · Apr 18, 2013 · Anesthesiology

Device Facts

• Record ID: K121659
• Device Name: BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
• Applicant: Arcos, Inc.
• Product Code: PDT · Anesthesiology
• Decision Date: Apr 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

BRDSS is a software-based fluid resuscitation calculator for hospital critical-care environments. Used by physicians or nurses to manage adult patients with ≥20% TBSA burns. Inputs include patient weight, % TBSA burned, and time of burn. System calculates hourly fluid recommendations; provides visual graphs of cumulative fluid volume, hourly fluid intake, and urine output. Includes safety warnings if primary fluid rate recommendation deviates by ±25% (and ±200mL/hr) from current rate. Assists clinicians in titration decisions to optimize fluid resuscitation during the critical 24-72 hour post-burn window.

Clinical Evidence

Bench testing and clinical user validation performed. No specific clinical trial data or performance metrics (sensitivity/specificity) provided in the summary.

Technological Characteristics

Portable software-based system. Operates as a decision support calculator. Features include data input validation, user warnings/alerts, and graphical data visualization. Adheres to standard hardware form factor and power requirements.

Indications for Use

Indicated for adult patients with ≥20% Total Body Surface Area (TBSA) burns. Used for hourly fluid resuscitation recommendations. Initiated within 24 hours of burn, ending by 72 hours post-burn.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• TRxF Intelligent Dosing System (K011571)

Submission Summary (Full Text)

{0}------------------------------------------------

Arcos

\$\rho^{1/2}\$

# Burn Resuscitation Decision Support System 510(k) Summary

APR 1 8 2013

| Submitted by: | Arcos, Inc.<br>866 W. 41st St.<br>Houston, TX 77018 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Chris Meador<br>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<br>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<br>seriously burned patients. It is used to calculate the next<br>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<br>K011571<br>TRxF Intelligent Dosing<br>System™ | Applicant<br>Burn Resuscitation Decision Support<br>System (BRDSS) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The IDS™ is a next-dose<br>calculator for any drug<br>that can be used by<br>physicians to calculate the<br>next dose for patients. | The BRDSS is a fluid calculator for use in<br>the care of seriously burned patients. It is<br>used to calculate the next dose of fluid for<br>patients. |

{1}------------------------------------------------

| ڪاري جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي<br>て | 6<br>-<br>C<br>う |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | 71-<br>0<br>"2 |

| Intended Use | The IDS is a software-<br>based drug-dosing<br>calculator designed for use<br>by the physician to<br>calculate the next dose of<br>any drug to achieve a<br>desired target. | The Burn Resuscitation Decision Support<br>System (BRDSS) is indicated for use in<br>the care of adult patients with 20% or<br>more Total Body Surface Area (TBSA)<br>burned, as a fluid resuscitation calculator<br>for hourly fluid recommendations. The<br>BRDSS is intended to be initiated within<br>24 hours of the burn incident and ending<br>by 72 hours post burn. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended User | Healthcare professional | Healthcare professional |
| Intended Use<br>Environment | Health care facility | Hospital critical-care environment |
| Human<br>Factors | Physician enters patient's<br>glucose values and<br>amounts of insulin.<br>Warnings are presented<br>when values are out of<br>range and /or insulin doses<br>are greater than or less<br>than 20% of the most<br>recent dose. | Physician or nurse enters patient weight,<br>% of body surface area burned and time of<br>burn. Warnings are presented when the<br>primary fluid rate recommendation is +/-<br>25% (and +/- 200mL/hr) from the current<br>primary fluid rate dose. In addition,<br>graphs are included to show patient's<br>cumulative volume of fluids received and<br>hourly fluids in and urine out. |
| Software-<br>Based<br>Dose<br>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 [phone] or [phone] 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

Page 1 of 1