Paul,
1.5 Telsa - currently the most common
3 Telsa - becoming popular
Putting "MR-conditional" constitutes or should be interpreted to constitute a significant change to the labeling. Thus, it would require a new 510(k) submission.
As for testing to claim "MR-conditional," please refer to
FDA Guidance.
Standards to refer to include ASTM F2052, F2119, F2182, and F2213
FDA recommends "Accurate assessment of the whole body averaged specific absorption rate (WB-SAR) used in your testing is critical to determining whether your testing represents reasonable worst-case heating conditions. Therefore, we recommend that you base WB-SAR assessments upon calorimetry measurements rather than relying on the MR scanner display, which may not have adequate accuracy."
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http://www.regulatorydoctor.com Riner VA
United States
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Original Message:
Sent: 04-10-2014 08:25
From: Paul Vagts
Subject: MR Compatibility
We are looking to conduct some MR testing of our titanium implants to determine the MR Conditional parameters for labeling. Should 1.5 Tesla or 3 Tesla be evaluated? Is there an industry standard on this? As a follow-up question, if this were to be added to the labeling of existing devices is that something that needs to be addressed in a 510(k) or is internal documentation sufficient to justify this change? Based on the FDA guidance document, "Deciding When to Submit ...", I am inclined to view this as a labeling change intended to be a "change in warnings and precautions" or the "labeling being revised for clarity to insure safer or more effective use". In either case, flowchart A leads to documentation. I have heard others claim this is a change to the intended use and therefore requires a traditional 510(k), but that seems excessive to me. Any thoughts or feedback?
Thanks a bunch!
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Paul Vagts
Parcus Medical
Sarasota FL
United States
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