(47 days)
Not Found
No
The summary describes a device that uses electronic regulation and Peltier elements for temperature control, with no mention of AI or ML terms, data sets, or performance metrics typically associated with AI/ML.
No
The device is indicated for the regulation of temperature of intravenous (IV) fluid bags prior to administration, not for direct therapeutic treatment of a patient. Its function is to prepare fluids, not administer therapy.
No
The device is described as an "IV warmer device" intended for regulating the temperature of IV fluid bags, not for diagnosing medical conditions.
No
The device description explicitly mentions hardware components like Peltier elements and a 12V DC power source, indicating it is a physical device with electronic controls, not software only.
Based on the provided information, the INFU Box is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to regulate the temperature of intravenous (IV) fluid bags prior to administration. This is a physical manipulation of a substance that will be introduced into the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description focuses on the mechanism for heating IV fluids (Peltier elements, airflow, temperature regulation). This aligns with a device that prepares a substance for administration, not one that analyzes a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The INFU Box is a medical device, but its function is related to the preparation and administration of fluids, not to in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 vehicle, such as ambulance or military vehicle.
Product codes
LGZ
Device Description
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.
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
Not Found
Intended User / Care Setting
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.
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)
Mechanical tests - vibration & chock (EN 1789:2007; IEC 60068-2-6; IEC 60068-2-64; IEC 60068-2-27): Tests showed that the device is safe for exposition of normal vibration and chock in ambulance vehicles. -Free fall test not necessary since device is stationary mounted.
IP tests (IEC 60529:1992+A1:2000+Corrigendum 2:2007+Corrigendum 3:2009): The device was classified and marked to class IP20.
Climatic tests (IEC 60068-2-1 test Ab; IEC 60068-2-2 test Bb; IEC 60068-2-78 test Cab): The tests showed that the device works as specified in intended use temperature and after storage in permitted storage/shipping temperature and humidity.
Effectiveness of intended use: Tests showed that error messages and signals works, that the device is effective -(target temperature is reached +/- 2°C in 2-4h). Manual and other labeling follows demands and contains all information and warnings. All materials are corrosion free.
EMC (IEC 60601-1-2): The device passed the EMC requirements and is safe considering EMC, in terms of conducted and radiated emission and electric fields, disturbance etc.
Electrical Safety (IEC 60601-1): Electromagnetic compatibility was tested to be ok. Protection, hazards etc were tested. In the first test some did not pass and were treated in document Appendix M Design update report and decided to have been adjusted to comply to requirements. A complementary test was made and passed, Appendix N.
User studies: Some devices were field tested in a winter practice with care personnel. These test results have not been included as result in application, a but have given input about user interface field findings for manufacturer.
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
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| 3918 Porsgrunn | |
| Norway | |
| Phone: | 0047-90610425 |
| Fax: | 0047-35515014 |
Contact Information 5.2
| Name: | Mr. Knut Fangberget |
|---|---|
| Address: | Kjolnes Ring 30 |
| 3918 Porsgrunn | |
| 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.
-
- The systems use electronically temperature regulation for IV liquids, just as INFU Box.
-
- The systems are intended for field and clinical applications.
-
- The systems provides with alarms for over-temp.
The INFU Box differs from the predicate devices in that:
-
- 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.
-
- 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 | |||
| -vibration & chock |
EN 1789:2007;
Applicable
parts:
• IEC 60068-2-6;
Test Fc
• IEC 60068-2-64;
Test Fh
• IEC 60068-2-27;
Test Ea/Eb | CECert GmbH | Tests showed that the
device is safe for
exposition of normal
vibration and chock in
ambulance vehicles. -Free
fall test not necessary
since device is stationary
mounted. | Appendix L |
| IP tests
IEC
60529:1992+A1:20
00
+Corrigendum
2:2007+Corrigendum
3:2009 | SP -Technical
Research Institute of
Sweden | The device was classified
and marked to class IP20. | Appendix H
(Test ID MR-
5) |
| Climatic tests
-according to
specified intended
use
• IEC 60068-2-1 test
Ab
• IEC 60068-2-2 test
Bb
• IEC 60068-2-78
test Cab | SP -Technical
Research Institute of
Sweden | The tests showed that the
device works as specified
in intended use
temperature and after
storage in permitted
storage/shipping
temperature and humidity. | Appendix K
Appendix A |
| Effectiveness of
intended use | Hotswap Jönköping
AB
-Internal tests at
engineering
consultant
company. | Tests showed that error
messages and signals
works, that the device is
effective -(target
temperature is reached +/-
2°C in 2-4h).
Manual and other labeling
follows demands and
contains all information
and warnings.
All materials are corrosion
free. | Appendix H
(other tests
are also
included in
document) |
| EMC
IEC 60601-1-2 | CECert GmbH | The device passed the
EMC requirements and is
safe considering EMC, in
terms of conducted and
radiated emission and
electric fields, disturbance
etc. | Appendix I |
| Electrical Safety
IEC 60601-1 | CECert GmbH | Electromagnetic
compatibility was tested
to be ok, see above.
Protection, hazards etc
were tested. In the first
test some did not pass and
were treated in document
Appendix M Design
update report and decided
to have been adjusted to | Appendix J
Appendix M
Appendix N |
| | | comply to requirements.
A complementary test was
made and passed,
Appendix N. | |
| User studies | Internal -Personnel
from MRE & field
study | Some devices were field
tested in a winter practice
with
care
personnel. These
test
results have not been
included as result in
application, a
but have
given input about user
interface
field
findings for manufacturer. | Not included
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 (800) 638-2041 or (301) 796-7100 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