The FDA released draft guidance containing recommendations for sponsors on 510(k) submissions for peripheral vascular atherectomy devices.
The guidance suggests that when comparing its device to another similar legally marketed one, the sponsor should make comparisons to indications for use, mechanism of operation, material, measurement tolerances and rotation speed, among other factors.
Because peripheral vascular atherectomy devices contain patient contacting materials, they may induce a harmful biological response. Thus, sponsors should determine the biocompatibility of all materials in the device that make contact with the patient. Devices identical in processing methods and composition to successful atherectomy devices can reference previous testing or documentation.