FDA Issues Final Guidance on 510(k) Submissions for Peripheral Vascular Atherectomy Devices
Posted February 18, 2020
A final guidance document issued by the Food and Drug Administration (FDA) on Feb. 13 details recommendations for 510(k) submissions for peripheral vascular atherectomy devices, which are designed to remove plaque from arteries outside of the heart.
The guidance document, which pertains only to atherectomy devices used in the peripheral vasculature (regulated under 21 CFR 870.4875 with product code MCW), provides recommendations for comparing new peripheral vascular atherectomy devices to similarly marketed, previous iterations of a device, called predicate devices. According to the FDA, manufacturers should establish the new device’s "substantial equivalence" by providing information demonstrating their device’s similarities and differences when compared with a predicate device.
Atherectomy refers to a clinical intervention to remove atherosclerotic plaque from arteries via cutting, shaving, sanding, or vaporizing, with the guidance document dividing the devices into four categories based on their mechanism of action: directional, rotational, orbital, and laser. The FDA noted that atherectomy devices used in the coronary vasculature (around the heart) are outside of the scope of the guidance, as they are Class III devices and require premarket approval application prior to marketing. The agency added, however, that “some of the information provided in this guidance document may be applicable to atherectomy devices with coronary indications.”
The guidance provides premarket submission recommendations for a number of other categories, including software, biocompatability, sterility, shelf life and packaging, battery testing, clinical performance testing, and labeling. In addition, manufacturers should provide proposed labels and labeling adequately describing the peripheral vascular atherectomy device, as well as its intended use and the directions for use. The labeling also should include device attributes such as rotational speed and duration of treatment.
Because they are prescription devices, the FDA noted that peripheral vascular atherectomy devices are exempt from having adequate directions for nonprescription use. Practitioners must be provided with adequate information in the labeling pertaining to use of the device, including “indications, effects, routes, methods, frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions.”
The FDA is accepting comments on this final guidance document at www.regulations.gov (docket FDA-2018-D-2494).
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