Presentation Authors: GILBERTO JOSÉ RODRIGUES*, JOINVILLE, Brazil, RAFAEL FERREIRA COELHO, WILLIAM CARLOS NAHAS, DENIS LEONARDO JARDIM, SÃO PAULO , Brazil
Introduction: There are two mainly pathways to gain a new medical device approval by the Food and Drug Administration (FDA): the Premarket Approval Application and the Premarket Notification, trough the 510k Clearances. The 510k pathway is less stringent, as the new device should have roughly the same characteristics to the &[Prime]predicate device&[Prime] that the new one is being compared. As little or no clinical evidence is required prior to market entry, safety concerns were reported for some devices in different areas. The FDA recalls medical devices posing safety risks. Our purpose is to analyze devices cleared by the 510k and FDA's recall database in uro-oncology over the last 4 years.
Methods: We reviewed FDAs medical devices approvals and recalls database through the FDA website (https://www.fda.gov). We identified all items cleared by the 510k route in section Gastroenterology/Urology (G/U) from 01/01/14 to 12/31/17 and selected only the products related to uro-oncology. Then, we found all the items recalled during the period for comparison.
Results: We found 776 medical devices cleared by the 510k route between 2014 and 2017, 162 (20.9%) in uro-oncology. Forty devices were cleared in robotics during this period (24.7% of total uro-oncology approvals), with no clear trends over the years (Table 1). Of the 48 recalls in G/U during the same period, 19 (39.6%) were in urology. Uro-oncology and robotics were responsible for 15 (79%) and 8 (42%) of these recalls, respectively. All recalls were classified as grade 2, which means that the product may cause temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death. Although robotics presented the highest rate of recalls per 510k approvals during the period (ratio=0.2), only 3 items were recalled in the last 2 years, representing a trend for reduction in the last 4 years.
Conclusions: Most items approved and also recalled during all the period were related to robotics surgeries, reflecting the predominance of this surgery method in the present days. Recalls were low-grade and there was a reduction trend of recalled items in the uro-oncology section. Hence, no significant safety concerns were detected by using the 510k pathway for medical devices approvals in uro-oncology.