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Could the software change significantly affect clinical functionality or performance specifications that are directly associated with the intended use of the device?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Changes in performance specifications encompass everything from routine specification changes necessary to improve device performance to significant product redesigns. For the purpose of this question, specifications include elements that could influence the device’s ability to clinically perform as intended. These specifications may address attributes such as speed, strength, response times, throughput, limits of operation, reliability, delivery rate, or assay performance.

If the software change could significantly affect clinical functionality or performance specifications that are directly associated with the intended use of the device, then submission of a new 510(k) is likely required. For in vitro diagnostic devices (IVDs), this includes a change that could have clinically significant impact in terms of clinical decision-making. This question does not address direct changes to the indications for use and/or intended use of the device.  

For IVDs, performance generally refers to the analytical and clinical specifications established as part of the most recent 510(k) clearance. Analytical performance refers to the documented ability of an IVD test or test system to measure or detect a target analyte or substance that the IVD test or test system is represented or purported to identify or measure. Clinical performance refers to the documented ability of an IVD test or test system to identify, measure, monitor, or predict the presence or absence of, or the future development of, a clinical condition or predisposition, for which the device is intended.

Depending on the assay, analytical performance specifications may be defined by:

  • Analytical Sensitivity: limit of detection, reactivity (inclusivity)
  • Analytical Specificity: exclusivity, cross-reactivity, interference
  • Cut-off and equivocal zone
  • Precision: site-to-site reproducibility, within-laboratory precision/repeatability

There are also times when IVD functionality or performance specifications could be changed but the change is not related to the IVD's intended use and the performance of the modified device could not be significantly affected when compared to previously cleared performance claims, and thus submission of a new 510(k) would not be required.

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