-
jp582 replied to the topic Device Class Confusion in the forum Project Management Process and Medical Device Development 8 years ago
Last year in medical device course, I submitted a project proposal on device called “Indirect Video Laryngoscope”. The purpose of that device is to make the process of intubation easier and quicker to perform. It can also be used for detailed examination of larynx and vocal cords. Indirect Video laryngoscope advance in technology helps doctors visualize closely and obtain bright and sharp image of vocal cords, and glottis. Uniqueness of this device is the distal chip technology has digital photo and video recording capability which helps eliminate separate camera assembly as in previous laryngoscopes. It also improves clinical practice, patient safety, less time required, easy to learn and perform, and highly successful techniques. Before my project proposal, I was very confused between class II and class III devices. After research, I found that it is a class II device which required 510K with clinical trial because that device was already in the market passed FDA regulations. I am assuming if my device causes any internal damage to patient then it would be class III with PMA required.