(47 days)
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.
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 INFU Box Type 0412A is an IV fluid warmer. The submission states that bench tests were performed to provide evidence that the device is safe and effective in regulating the temperature of IV fluid bags prior to administration.
1. Table of acceptance criteria and the reported device performance:
| Type of Test/Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Tests (Vibration & Shock - EN 1789:2007, IEC 60068-2-6 (Test Fc), IEC 60068-2-64 (Test Fh), IEC 60068-2-27 (Test Ea/Eb)) | Device remains safe and functional under normal vibration and shock conditions in ambulance vehicles. | Tests showed that the device is safe for exposure to normal vibration and shock 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) | Device meets specified ingress protection class. | 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) | Device functions as specified in intended use temperature and after storage in permitted storage/shipping temperature and humidity. | 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 | Error messages and signals work. Target temperature is reached within +/- 2°C within 2-4 hours. Manual and labeling meet demands. All materials are corrosion free. | Tests showed that error messages and signals work, 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) | Device meets EMC requirements (conducted/radiated emission, electric fields, disturbance). | 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) | Device meets electrical safety requirements, including protection and hazards. | 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. |
2. Sample size used for the test set and the data provenance:
- The document describes "bench tests" and "internal tests."
- Sample Size: Not explicitly stated as a numerical sample size (e.g., N=X devices). It refers to "the device" implying testing was done on one or more units to demonstrate compliance.
- Data Provenance: The tests were conducted by various organizations:
- CECert GmbH (Germany/Europe based - implied by GmbH)
- SP - Technical Research Institute of Sweden (Sweden)
- Hotswap Jönköping AB - Internal tests at engineering consultant company (Sweden, implied by "Jönköping" and "AB" which is a Swedish company type)
- Medical Rescue Equipment Holding A/S (Norway) - for "User studies"
The tests are laboratory-based and simulated real-world conditions; therefore, the data provenance is from laboratory testing performed in Europe (Germany, Sweden, Norway). The studies are prospective in the sense that they are designed and conducted specifically to test the device's performance against predefined standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the submission. The tests performed are primarily engineering and performance tests against established technical standards (e.g., IEC, EN) rather than clinical evaluations requiring expert consensus on subjective outcomes.
- For the "Effectiveness of intended use," the ground truth is objective: reaching a target temperature within a specific range and time.
4. Adjudication method for the test set:
- This information is not applicable as the tests are objective engineering and performance verification assays against established standards, not studies requiring expert adjudication of subjective findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a fluid warmer, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a hardware fluid warmer, not an algorithm. The reported tests are for the standalone device's physical and functional performance.
7. The type of ground truth used:
- The ground truth for most tests (Mechanical, IP, Climatic, EMC, Electrical Safety) is objective and based on international and national standards (e.g., IEC 60068, IEC 60529, IEC 60601-1-2, EN 1789).
- For "Effectiveness of intended use," the ground truth is quantifiable performance benchmarks: reaching a specific temperature range (+/- 2°C) within a defined timeframe (2-4 hours).
- For "User studies," the ground truth would be user feedback and observations, though the document notes these were "not included as result in application" but "given input about user interface field findings for manufacturer."
8. The sample size for the training set:
- This information is not applicable as the device is not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable as the device is not an AI/machine learning system.
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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 303918 PorsgrunnNorway |
| Phone: | 0047-90610425 |
| Fax: | 0047-35515014 |
Contact Information 5.2
| Name: | Mr. Knut Fangberget |
|---|---|
| Address: | Kjolnes Ring 303918 PorsgrunnNorway |
| 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
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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.
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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 & chockEN 1789:2007;Applicableparts:• IEC 60068-2-6;Test Fc• IEC 60068-2-64;Test Fh• IEC 60068-2-27;Test Ea/Eb | CECert GmbH | Tests showed that thedevice is safe forexposition of normalvibration and chock inambulance vehicles. -Freefall test not necessarysince device is stationarymounted. | Appendix L |
| IP testsIEC60529:1992+A1:2000+Corrigendum2:2007+Corrigendum3:2009 | SP -TechnicalResearch Institute ofSweden | The device was classifiedand marked to class IP20. | Appendix H(Test ID MR-5) |
| Climatic tests-according tospecified intendeduse• IEC 60068-2-1 testAb• IEC 60068-2-2 testBb• IEC 60068-2-78test Cab | SP -TechnicalResearch Institute ofSweden | The tests showed that thedevice works as specifiedin intended usetemperature and afterstorage in permittedstorage/shippingtemperature and humidity. | Appendix KAppendix A |
| Effectiveness ofintended use | Hotswap JönköpingAB-Internal tests atengineeringconsultantcompany. | Tests showed that errormessages and signalsworks, that the device iseffective -(targettemperature is reached +/-2°C in 2-4h).Manual and other labelingfollows demands andcontains all informationand warnings.All materials are corrosionfree. | Appendix H(other testsare alsoincluded indocument) |
| EMCIEC 60601-1-2 | CECert GmbH | The device passed theEMC requirements and issafe considering EMC, interms of conducted andradiated emission andelectric fields, disturbanceetc. | Appendix I |
| Electrical SafetyIEC 60601-1 | CECert GmbH | Electromagneticcompatibility was testedto be ok, see above.Protection, hazards etcwere tested. In the firsttest some did not pass andwere treated in documentAppendix M Designupdate report and decidedto have been adjusted to | Appendix JAppendix MAppendix N |
| comply to requirements.A complementary test wasmade and passed,Appendix N. | |||
| User studies | Internal -Personnelfrom MRE & fieldstudy | Some devices were fieldtested in a winter practicewithcarepersonnel. Thesetestresults have not beenincluded as result inapplication, abut havegiven input about userinterfacefieldfindings for manufacturer. | Not includedin application. |
Table 1: Summary of performed tests
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:
:
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Further information in referenced documents and in 018_"Performance Testing -Bench".
End of 510(k) summary
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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.
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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
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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
§ 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).