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Bit more information on the Prizma

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The following technological differences exist between the subject and predicate devices: The main difference is the addition of the mobile application that controls the device. The user downloads the application, and pairs the Prizma BLE with smartphone. To run tests, the Prizma application is touched, whereby main screen open with large test icons. Upon touching a test icon, the test screen opens with instructions how to make contact with sensor. Upon test end, the user can add comments to tests and send results via email. In addition, at end of the tests, the data is automatically transferred over secured BLE protocol from the Prizma to the smartphone where they are stored. Browsing test results history (last five tests) can be performed by touching the Browse icon. The performance of the sensors against their predicate is summarized below.
ECG From technology perspective and parameters defined by the standards, both devices are essentially identical. There are some small differences between the devices, such as the dynamic range, which is better in the Prizma due to the fact that the Prizma was designed to comply with IEC-60601-2-47 which is a newer standard that requires better performance, compare to the EC-38 (1998) that the HealthePod was designed to comply with. In addition, for some parameters, the Prizma performed even better than the Health-ePod (e.g. sampling rate, resolution, heart rate range), which is due to technology and chip improvements over time. The largest difference between the Prizma and the Health-ePod is the use of the mobile application which the Prizma which is expected to simplify device use as cell phones have larger screens than that used in the Health-ePod. Another difference is that the Prizma is intended solely for adults while the Health-ePod is intended also for pediatric use.

SpO2 The SpO2 sensor in the Prizma and the PulseOx 5500 finger device are similar. From a technology point of view, both devices use the finger to measure the oxygen saturation level. Both devices use reflective technology with similar ranges of wavelength. Both devices report 40% to 100% saturation. The difference between the devices are minor and are primarily related to the fact that the PulseOx 5500 can be used continuously while the Prizma can be used for spot measurement. In addition, like in the case of the ECG, the use of mobile app is expected to simplify the test by using a larger screen, animation that explain how to do the test, and an indication when the test is over.
Temperature From technology point of view, the Health-ePod and the Prizma are identical. Both use the Melexis IR sensor. Both devices measure the skin temperature from the same position on the body (behind the Earlobe). The Health-ePod uses the MLX-90614 and the Prizma uses the MLX-90615 which is the newer generation of the MLX 90614 sensor. The relevant differences between the sensors are the thermal stability which is better in the MLX-90614. This is mostly due to the housing size of the 90614, which is bigger but can be easily resolved by using a metal cap on the 90615 as we did in our design to improve the stability. The resolution, although better in the 90614, doesn’t have clinical significance when measuring skin / body temperature. The measurement range is bigger in the 90614 due to its larger size, but in case of human skin and body temperature, the clinically relevant range can be measured by both devices. Both devices can measure skin temperature accurately. The Health-ePod uses a look-up table which was developed based on a clinical trial to convert the skin temperature to body temperature. Finally, the Prizma, like in the ECG and SpO2, uses the Mobile App to initiate the test in a convenient manner.

Conclusion: The differences between the device and its predicates do not raise different types of safety and effectiveness questions. Differences between the devices are supported by testing demonstrating at least equivalent performance. Therefore, the device is substantially equivalent to its predicate devices.