547 - Data Submitted for IR Devices Seeking FDA 510(k) Approval: Quality and Implications for Patient Safety

Purpose: To evaluate the data submitted for the FDA 510(k) approval of IR devices.

Materials and Methods: A dataset consisting of 112 representative IR devices (central and peripheral vasculature, brain vasculature, and tissue) was generated from the FDA Breakthrough Pathway and FDA 510(k) database between January 2020 and July 2025. For each device, we categorized the level of evidence of the data submitted (Bench only, Bench+Animal, Bench+Human, or Full Clinical Trial), peer reviewed publications pre/post approval, and adverse events (deaths, injuries, and device malfunctions) reported in MAUDE within 12 months following FDA approval. Devices were classified by pathway (Breakthrough vs. Traditional 510(k)). Comparative statistics were used to evaluate differences between pathways.

Results: Table 1 illustrates the level of evidence of data submitted by pathway. Preclinical data alone accounted for 80.6% (79/98) of approvals in the traditional pathways. Among the 112 approved IR devices, 45 (40.2%) had no peer-reviewed publication either before or after approval. 78.6% (11/14) of the data submitted for devices in the breakthrough category were clinical trials compared to 16.3% (16/98) in the traditional category (p< 0.0001). All 14 devices in the breakthrough category had peer-reviewed publications compared to 54.1% (53/98) of devices in the traditional category (p = 0.001). Adverse events reported to MAUDE differed between the two pathways. Breakthrough devices accounted for 47 malfunctions (n=5/14), 58 injuries (n=5/14) and 9 deaths (n=3/14). Traditional devices accounted for 133 malfunctions (n=16/98), 40 injuries (n=13/98) and 16 deaths (n=5/98). The difference in injury reports between the two pathways was statistically significant (p< 0.0001). In the traditional group, most adverse events occurred in devices approved with only preclinical testing 97.7% (130/133) of malfunctions, 90% (36/40) of injuries, and 50% (8/16) of deaths).

Conclusion: This random evaluation of 112 FDA-approved IR devices demonstrated that the majority of FDA 510(k) approvals in the traditional category are issued with only preclinical supporting data. Furthermore, up to 40% of approved devices in the traditional category enter the market and are used in patient care without pre- or post- FDA approval peer reviewed publication.