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510(k) Data Aggregation
(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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