FDA Updates Premarket Notification Submissions Guidance for Peripheral Atherectomy Devices
By: Randolph Fillmore
June 21, 2021
Categories: AAMI News, Medical Device Manufacturers
The Food and Drug Administration (FDA) updated its Premarket Notification Guidance for peripheral vascular atherectomy devices aimed at removing atherosclerotic plaque from diseased arteries by cutting, shaving, sanding, or vaporizing.
The final guidance, Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions, reviews four design categories for atherectomy devices—directional, rotational, orbital and laser—and makes premarket submission recommendations.
The scope of the updated guidance is limited to atherectomy devices used in the peripheral vasculature regulated under 21 CFR 870.4875 with the product code and regulation number MCW 870.4875 Intraluminal Artery Stripper.
Premarket submission recommendations include device description details and predicate device description if needed. Device description should include identifying the device by regulation and product code as described in section III of the revised guidance as well as identifying all accessories and describing their function(s). Submissions should also include:
- Description of device operation mechanism
- Description of technological characteristics
- Listing of materials
- Identification of coating and images or engineering drawings
The FDA recommends describing the technical and performance data for the device and providing a brief device design description.
According to the guidance document, the submission should describe all device models and configurations if the submission is for multiple device models. In addition, include information on how the device reaches its desired rotational speed and relevant information on device functional physical and environmental considerations.
Predicate device comparisons should also be included for devices reviewed in 510(k) processes to compare new devices to those already marketed and demonstrate substantial equivalence and how the new device is similar to, or different from, the predicate device. The FDA noted that “side-by-side” comparisons are desirable where possible.
The agency is accepting comments at www.regulations.gov, docket FDA-2018-D-2494.