Research Project
6830442
DESCRIPTION (provided by applicant): Cervical Cancer is the second most common type of cancer in women worldwide and the leading cause of cancer related mortality in women in developing countries. Early detection and diagnosis can saves lives and reduce the burden on the national healthcare system. We have built a non-invasive research-prototype point-of-care device to detect early cancerous conditions of the uterine cervix. We have tested this prototype in a multi-center national study accruing data from 600 women for training our algorithm. Through conversations with the FDA we now have in place a pivotal trial protocol for validating our algorithm. We will use a pre-production version of our device in this pivotal study. The pre-production device will be a cost and size reduced, portable, rugged and user-friendlier device and is intended to be identical to the device intended for sale without incurring the tooling costs necessary to enter the production phase. In Phase I of this fast track application we will address the high-risk aspects of building this pre-production device as well as arrive at a conceptual design. In Phase II we will finalize this design (both component level and systems integration) and build ten copies of the device to support the pivotal trial. We will also complete necessary systems tests and determine inter/intra device variability. We will conclude with the design documentation necessary for our PMA submission.
