INFU BOX TYPE 0412A

K120860 · Medical Rescue Equipment Holding AS · LGZ · May 8, 2012 · General Hospital

Device Facts

• Record ID: K120860
• Device Name: INFU BOX TYPE 0412A
• Applicant: Medical Rescue Equipment Holding AS
• Product Code: LGZ · General Hospital
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INFU Box is indicated for the regulation of temperature of intravenous (IV) fluids bags prior to administration. The device is intended for bags with crystalloid fluids only. Intended users are health care professionals. The device is intended for use in clinical and field environments and is intended to be mounted in a ground based field operating vehicle, such as ambulance or military vehicle.

Device Story

INFU Box Type 0412A is an electronically regulated IV fluid warmer designed for clinical and field use (e.g., ambulances, military vehicles). It maintains the temperature of up to three 1000 ml IV crystalloid fluid bags. The device utilizes electronically controlled Peltier elements to create a temperature difference between internal and external airflow, using environmental air for regulation. Powered by a 12 V DC source, it features a digital display and integrated alarms for over-temperature conditions. Healthcare professionals operate the device to ensure fluids are at a controlled temperature prior to administration, potentially benefiting patients by preventing hypothermia during transport or field care. The device is designed for stationary mounting within vehicles.

Clinical Evidence

Bench testing only. Testing included mechanical (vibration/shock per IEC 60068-2), ingress protection (IP20), climatic (IEC 60068-2-1/2/78), EMC (IEC 60601-1-2), and electrical safety (IEC 60601-1). Effectiveness testing confirmed the device reaches target temperature within +/- 2°C in 2-4 hours. Field user studies were conducted but not included as formal clinical data in the application.

Technological Characteristics

Electronically regulated IV fluid warmer using Peltier elements for temperature control. Powered by 12 V DC. Designed for mounting in ground-based vehicles. Meets IEC 60601-1, IEC 60601-1-2, and SS-EN 1789:2007 standards. IP20 rated. Features digital display and over-temperature alarms. Corrosion-free materials.

Indications for Use

Indicated for temperature regulation of crystalloid IV fluid bags prior to administration. Intended for use by healthcare professionals in clinical and field environments, including ground-based vehicles like ambulances or military vehicles.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Soft Sack, FloorMount and Pak 2, IV warmer devices (K060851)
• Bair Hugger® Blood/Fluid Warmer (K973741)

Submission Summary (Full Text)

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

K120860

# MAY - 8 2012

## 510(k) Summary - Traditional Submission 5

This 510(k) summary of Safety and Effectiveness is submitted as part of the PreMarket Notification in accordance with the requirements of 21CRF 807.92.

### 5.1 510(k) Submitter

| Name: | Medical Rescue Equipment Holding A/S |
|----------|---------------------------------------------|
| Address: | Kjolnes Ring 30<br>3918 Porsgrunn<br>Norway |
| Phone: | 0047-90610425 |
| Fax: | 0047-35515014 |

### Contact Information 5.2

| Name: | Mr. Knut Fangberget |
|----------|---------------------------------------------|
| Address: | Kjolnes Ring 30<br>3918 Porsgrunn<br>Norway |
| Phone: | 0047-9156 1581 |
| Fax: | 0047-35515014 |

### 5.3 Date of Preparation

August, 2010

### 5.4 Identification of the Device

- 1 . Trade Name: INFU Box Type 0412A 2. Common Name: IV fluid warmer Classification Name: Warmer, Thermal, Infusion fluid 3. Product code: 4. LGZ
#### Predicate Devices 5.5

Soft Sack, FloorMount and Pak 2, IV warmer devices (K060851) and Bair Hugger® Blood/Fluid Warmer (K973741)

### Indications for Use 5.6

The INFU Box is indicated for the regulation of temperature of intravenous (IV) fluid bags prior to administration. The device is intended for bags with crystalloid fluids only. Intended users are health care professionals. The device is intended for use in clinical and field environments and is intended to be mounted in a ground based field operating

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

vehicle, such as ambulance or military vehicle.

Image /page/1/Picture/1 description: The image shows a square electrical panel with a door. The panel is light-colored and has a dark border. There is a handle on the right side of the door, and a row of circuit breakers is visible at the top of the panel.

Image /page/1/Picture/2 description: The image shows a wall-mounted electrical panel with an open door. The panel is rectangular and has a series of horizontal slots or openings inside. There is a digital display at the top of the panel, and the door is hinged on the left side.

Figure 1 INFU Box warmer device

## Description of Device 5.7

The INFU box warmer device is electronically regulated to obtain and maintain a preset temperature. Electronically controlled Peltier elements are used to produce a temperature difference between an internal and external airflow. The device uses environmental air to regulate the temperature. It is designed to maintain three 1000 ml IV liquid bags. The main system is powered by a 12 V DC source.

The device meets the applicable requirements of IEC 60601-1-1, IEC 60601-1-2 and SS-EN 1789:2007.

### Comparison with Legally Marketed Predicate Devices 5.8

The INFU Box is similar to the predicate devices in that:

- The systems are intended for the warming of IV fluids prior to administration, and 1. intended users are designated to be healthcare professionals.
- 2. The systems use electronically temperature regulation for IV liquids, just as INFU Box.
- 3. The systems are intended for field and clinical applications.
- 4. The systems provides with alarms for over-temp.

The INFU Box differs from the predicate devices in that:

- 1. The Bair Hugger can also operate with blood products, and is an "in-line" warming system. The INFU Box is not intended to provide this feature.
- 2. INFU Box is intended to be mounted in a ground based vehicle or hospital/ nursing centre, why mechanical robustness and portability demands are different on this product.

{2}------------------------------------------------

To support information of substantial equivalence and to follow up risk management, a number of bench tests have been performed. These tests give evidence to the fact that the INFU Box device indeed is safe and effective in providing with a regulation of the temperature of IV fluid bags prior to administration.

#### 5.9 Conclusion

The INFU Box device is substantially equivalent to the identified legally marketed devices intended for use in warming IV bags containing crystalloid fluids bags, using conduction from an external electronic component.

The potential hazards have been studied and controlled as a part of the product development process, including risk analysis, test and design consideration, and planned verification and validation testing processes. The INFU Box is intended for use in clinical and field environments comparable to the predicate devices.

Based on a comparison of the performance characteristics and the results from the tests, it is concluded that the INFU Box is substantial equivalent to the predicate devices and therefore safe and effective for its intended use.

| Type of test/-s | Place of testing | Result | References |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Mechanical tests<br>-vibration & chock<br><br>EN 1789:2007;<br>Applicable<br>parts:<br>• IEC 60068-2-6;<br>Test Fc<br>• IEC 60068-2-64;<br>Test Fh<br>• IEC 60068-2-27;<br>Test Ea/Eb | CECert GmbH | Tests showed that the<br>device is safe for<br>exposition of normal<br>vibration and chock in<br>ambulance vehicles. -Free<br>fall test not necessary<br>since device is stationary<br>mounted. | Appendix L |
| IP tests<br><br>IEC<br>60529:1992+A1:20<br>00<br>+Corrigendum<br>2:2007+Corrigendum<br>3:2009 | SP -Technical<br>Research Institute of<br>Sweden | The device was classified<br>and marked to class IP20. | Appendix H<br>(Test ID MR-<br>5) |
| Climatic tests<br>-according to<br>specified intended<br>use<br><br>• IEC 60068-2-1 test<br>Ab<br>• IEC 60068-2-2 test<br>Bb<br>• IEC 60068-2-78<br>test Cab | SP -Technical<br>Research Institute of<br>Sweden | The tests showed that the<br>device works as specified<br>in intended use<br>temperature and after<br>storage in permitted<br>storage/shipping<br>temperature and humidity. | Appendix K<br>Appendix A |
| Effectiveness of<br>intended use | Hotswap Jönköping<br>AB<br>-Internal tests at<br>engineering<br>consultant<br>company. | Tests showed that error<br>messages and signals<br>works, that the device is<br>effective -(target<br>temperature is reached +/-<br>2°C in 2-4h).<br><br>Manual and other labeling<br>follows demands and<br>contains all information<br>and warnings.<br><br>All materials are corrosion<br>free. | Appendix H<br>(other tests<br>are also<br>included in<br>document) |
| EMC<br>IEC 60601-1-2 | CECert GmbH | The device passed the<br>EMC requirements and is<br>safe considering EMC, in<br>terms of conducted and<br>radiated emission and<br>electric fields, disturbance<br>etc. | Appendix I |
| Electrical Safety<br>IEC 60601-1 | CECert GmbH | Electromagnetic<br>compatibility was tested<br>to be ok, see above.<br><br>Protection, hazards etc<br>were tested. In the first<br>test some did not pass and<br>were treated in document<br>Appendix M Design<br>update report and decided<br>to have been adjusted to | Appendix J<br>Appendix M<br>Appendix N |
| | | comply to requirements.<br>A complementary test was<br>made and passed,<br>Appendix N. | |
| User studies | Internal -Personnel<br>from MRE & field<br>study | Some devices were field<br>tested in a winter practice<br>with<br>care<br>personnel. These<br>test<br>results have not been<br>included as result in<br>application, a<br>but have<br>given input about user<br>interface<br>field<br>findings for manufacturer. | Not included<br>in application. |

## Table 1: Summary of performed tests

{3}------------------------------------------------

:

:

{4}------------------------------------------------

Further information in referenced documents and in 018_"Performance Testing -Bench".

End of 510(k) summary

{5}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure. The bird is depicted with three curved lines forming its body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Knut Fangberget Medical Rescue Equipment Holding A/S Postboks 186 Porsgrunn Norway 3901

MAY - 8 2012

Re: K120860

Trade/Device Name: INFU Box Type 0412A Regulation Number: Unclassified Regulation Name: Warmer, Thermal, Infusion Fluid Regulatory Class: II Product Code: LGZ Dated: March 22, 2012 Received: March 22, 2012

Dear Mr. Fangberget:

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.

{6}------------------------------------------------

## Page 2- Mr. Fangberget

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 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 vours.

Anthony D. Smith

Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

{7}------------------------------------------------

## Indications for Use Statement 4

Applicant: Medical Rescue Equipment Holding AS

510(k) Number (if known): __

Device Name: __ INFU Box Type 0412A

## Indications for Use:

The INFU Box is indicated for the regulation of temperature of intravenous (IV) fluids bags prior to administration. The device is intended for bags with crystalloid fluids only. Intended users are health care professionals. The device is intended for use in clinical and field environments and is intended to be mounted in a ground based field operating vehicle, such as ambulance or military vehicle.

Over-The-Counter Use Prescription Use x AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rin C. Chapa 5/7/12

(Division Sign-Off) (UNISION Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120860