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Regulatory Focus™ > News Articles > 2020 > 2 > FDA Revises Atherectomy 510(K) Guidance in Response to Cook Comments

FDA Revises Atherectomy 510(K) Guidance in Response to Cook Comments

Posted 12 February 2020 | By Michael Mezher 

FDA Revises Atherectomy 510(K) Guidance in Response to Cook Comments

The US Food and Drug Administration (FDA) on Wednesday finalized guidance laying out its expectations for 510(k) submissions for peripheral vascular atherectomy devices, which are used to remove plaque in the peripheral vasculature through cutting, shaving, sanding or vaporization.
The 27-page guidance finalizes a draft version released in 2018 and includes recommendations for the descriptive characteristics, labeling, biocompatibility, sterility, nonclinical, animal and clinical performance testing needed to establish substantial equivalence to a predicate device.
FDA says it revised the guidance in response to comments during the public consultation on the draft version. Only one company, the Cook Group, submitted comments, and some of the changes made in the final guidance reflect the company’s suggestions.
For instance, FDA has replaced recommendations for using “measurement tolerances” as part of the predicate device comparison with “dimensional characteristics,” as suggested by Cook.
“‘Dimensional characteristics’ meaning length, French size, cutter dimensions, etc. would be more appropriate,” Cook wrote, noting that “one cannot know device tolerances … of a competitive predicate, nor would FDA traditionally expect to see this characteristic as a substantial equivalence determination feature.”
FDA also expanded its recommendations for corrosion resistance testing to include a recommendation from Cook explaining that “visible signs of corrosion may lead to degradation of performance characteristics, even if corrosion of metallic components after exposure to corrosive environment does not lead to potential toxicity or embolization.”
The final guidance removes a subsection on assessing tip robustness and adds a reference to FDA’s Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance.
Additionally, FDA added a recommendation that the device’s label should “include a description of how long [the] device takes to achieve its labeled speed […] and orbit performance data, if applicable.”
FDA, Federal Register Notice

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