The US Food and Drug Administration (FDA) issued draft guidance Thursday to aid sponsors in developing 510(k) submissions for peripheral vascular atherectomy devices.
The 31-page document provides recommendations on predicate device comparisons, labeling, biocompatibility, sterility and study endpoints, among other components of a 510(k) submission.
The draft policies outlined in the guidance are intended to supplement relevant FDA final guidance, such as the 2005 final guidance
on formatting for traditional and abbreviated 510(k)s. The guidance comes at a time when the abbreviated 510(k) program is being expanded to encourage participation for appropriate device types, though these have yet to be determined
Study endpoint considerations include conducting multi-center, prospective studies, as well as safety and performance assessments. Labeling should describe a device’s “indications, effects, routes, methods, frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions,” according to the draft guidance.
FDA recommends conducting clinical studies, rather than non-clinical, for this device type.
“We believe a clinical study evaluating multiple operators, patient demographics, and lesion characteristics represents the least burdensome approach to demonstrate substantial equivalence,” FDA wrote. “Therefore, we recommend that you conduct in vivo
studies to evaluate device safety and effectiveness for new and modified peripheral vascular atherectomy devices.”
The draft guidance also provides details on recommended software documentation to include in a 510(k), pointing to four previously finalized guidances. These include guidances on content of premarket submissions for software
in medical devices and for cybersecurity management
Further, the draft guidance lists several examples of modifications to a peripheral atherectomy device that would require a new 510(k), such as significant changes to device dimensions.
It also clarifies that atherectomy procedures have been used for treatment of coronary artery disease as well, but “atherectomy devices used in the coronary vasculature are class III devices, which require a premarket approval (PMA) application before marketing.”
Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions