FDA CDRH 510(k) Hysteroscopes and Laparoscopes

“Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for a 510(k)”

This guidance document was issued in final form March 7, 1996. Section IV.G software indicates that software in these devices are either minor or moderate levels of concern depending on the design of the particular device. The obsolete 1991 reviewer guidance for computer controlled medical devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” is referenced and the current software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” should be referenced in place of this when preparing a 510(k)

This section of the guidance goes on to itemize and emphasize that description of the software development activities and life cycle should be provided along with requirements and design information inculding hardware requirements, programming language, and program size and traceability between safety requirements and hazards. It goes on to require a structure chart depicting the particioning of the system into functional units and V&V information for unit integration and system testing as well as results and sufficient detail to demonstrate that software requirements were met and concludes with the requirement to provide a software version number and date as well as a list of any remaining bugs or errors. So this guidance document is fairly specific in terms of software information to be inculded in the 510(k).

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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