Human Factors Validation for an Upgraded LED Phototherapy Device

Problem Statement​:

The customer upgraded an LED phototherapy device to a larger treatment area (30x50 cm) by incorporating a new light engine, power supply, and controller. However, the need for a Human Factors validation study was not initially recognized, as the updated design did not introduce new user tasks or significantly modify the existing validated user interface, except for the minor updates to the Instructions for Use (IFU). This oversight could pose a potential issue for FDA 510(k) regulatory submissions. ​

Solution​:

Since the IFU warnings and labels are a critical component of the user interface and play a significant role in user interactions with the device, it is essential to conduct a Human Factors study to validate these updates. We proposed to conduct an additional Human Factors (HF) study focused on the IFU warnings and labels for the updated device which were not previously validated for the predicate device. We supported in developing the Human Factors validation plan/protocol and conducting the study. Also, compiled the Human Factors results into a detailed Human Factors Validation report and additionally incorporated a rationale into the Usability Engineering File and HFE summary report.

The report documented participant performance and subjective assessments, demonstrating that the updated device is safe and effective for its intended users in the intended use environment, with no critical use errors, consistent with the findings from the predicate device’s HF validation.

Key Benefits:

• Regulatory Compliance: The supplemental HF study ensured adherence to FDA requirements for Human Factors validation and minimized the risk of non-compliance, delays or rejections.​
• Enhanced User Safety: By validating IFU and label comprehension for the updated device, the study confirmed that users could effectively interact with the device without critical use errors, thereby improving overall safety and reducing the likelihood of adverse events.​
• Validated Effectiveness: The study provided evidence that the updated device performed safely and effectively in the intended use environment, aligned with user expectations, and supported the findings from the predicate device’s HF validation, thus reinforcing the device's reliability.​