Redesigned and extended the software control system of an ultrasonic surgery system with a focus on meeting regulatory compliance.

Context

The client came to us with a working prototype for a portable, ultrasonic energy system, designed for use by medical practitioners to remove soft tissue during surgery. BCA was tasked to design firmware to control this system and provide documentation needed for FDA submission. The software requirements included the following:

• Provide hardware control capability
• Provide analog data acquisition
• Provide timing resources
• Provide data logging
• Support remote communication and data transfer
• Support the user interface
• Provide redundancy of hardware error detection
• Provide FDA software documentation
• Integrate into production model

Solution

BCA designed this system using our custom royalty-free kernel based on finite state machine architecture. This was written using the C Programming Language for ease in maintenance and fast execution. The design resulted in a compact and easily testable code base. BCA supplied documentation for requirements, software architectural design, and verification testing used for the client’s FDA 510k submission.