Masters Applied Projects

Project 4

Developing a Test Protocol for Phoenix Technology’s Ophthalmic Camera, the ICON GO, for FDA Pre-Submission Adhering to Light Safety Hazard Standards for Ophthalmic Instruments

Student:

Renee Chao

Mentors:

Dr. Douglas Shepherd, PhD – Arizona State University, Department of Physics

Dr. Barbara Smith, PhD – Arizona State University, SBHSE

Dr. Vincent Pizziconi, PhD – Arizona State University, SBHSE

YouTube Link:
View the video link below before joining the zoom meeting

Zoom Link:
https://asu.zoom.us/j/83089544614


Abstract:

Retinopathy of prematurity (ROP) is an eye disorder that affects premature infants. The disorder is caused by abnormal blood vessel growth at the retina, leading to the detachment of the retina and eventually blindness if not properly treated. Currently optometrists and doctors identify the condition of the infant’s eye through imaging devices where they can track the progression and stage of the eye disorder. Phoenix Technology is now aiming to market their Ophthalmic camera, the ICON GO, which is a portable option to their first device – the ICON cart. In this study, we hypothesized that a new test protocol is needed to determine light safety hazard for this new portable option which will affect FDA premarket notification. We will first analyze the two light safety standards: ISO 15004:2-2007 and ANSI Z80.36 – 2021 to ensure the test protocol will adhere to their requirements and emission limits. We will then devise the test method following the guidelines from both standards. Once that has been developed, we will then produce a test data collection to see how the results of our test method will compare to the emission limits provided in the standards. The result of this study will follow with Phoenix Technology submitting a pre-submission to FDA to get the test protocol approved before submitting a 510(k) premarket notification with the limits from the protocol.