Circadia Health Case Study: 510k Clearance
Premise
In 2019, Circadia Technologies was pursuing FDA 510(k) clearance for the C100 System, which consists of a contactless breathing monitor for respiratory rate data measurement, mobile application for specific monitor configuration and data review, and a cloud service for clinical staff review of patients’ respiratory data.
Development of the C100 System was close to completion, and Circadia Technologies needed assistance with catching up the documentation required for the 510(k) submission. Circadia Technologies initially reached out to RookQS for assistance with establishing the design and risk documentation for their C100 System, including software development documentation per IEC62304.
Scope of Work
The scope of work for Circadia Technologies first included a coaching role to establish design control documentation and risk analysis documentation for the monitor, establishment of software documentation, and execution of testing for the mobile application. After the initial scope of work was completed, Circadia Technologies additionally requested RookQS’ assistance in putting together the 510(k) submission, and submitting it to the FDA.
Engagement
RookQS began by creating a risk management plan, risk analysis matrix, and risk management report for the C100 System. RookQS utilized past experiences with electrical medical devices and software as a medical device (SaMDs) to ensure common risks were considered, and appropriately mitigated.
A framework was provided for software documentation to be established as listed in FDA guidance documents. Technical details and software testing results were provided by Circadia Technologies, which RookQS reviewed to preemptively address any potential questions from the FDA.
Additionally, RookQS handled creation of the cybersecurity risk management plan and the associated risk analysis, and ensured a traceability matrix was completed to establish full design control traceability of all three components of the C100 System.
Finally, RookQS compiled the aforementioned documentation, along with all other required administrative documents, into the final submission package to send to the FDA. RookQS continued to help facilitate the review process with the FDA after initial submission, to facilitate Circadia Technologies first 510(k) clearance.
Outcome
With RookQS’ guidance, Circadia Technologies was able to set up the risk management and software documentation needed to support their 510(k) submission; Circadia Technologies received their 510(k) clearance for the C100 System on June 24, 2020.