SCOUT MD Surgical Guidance System

The SCOUT MD Surgical Guidance System is an implantable reflector marker device used to mark biopsy sites or soft tissue sites intended for surgical removal. A reflector is placed percutaneously in soft tissue for more than 30 days, and during surgery, a handheld guide connected to a console uses radiofrequency and infrared detection to locate and guide removal of the marked tissue.

The subject device is identical to the predicate (K231468) in mechanism of operation, materials, components, and design. The two modifications are: (1) the delivery system now has MR Conditional labeling instead of MR Unsafe, and (2) the reusable guides can now be sterilized using STERRAD 100S, NX, and NX100 systems in addition to manual cleaning and disinfection.

Software verification and validation per IEC 62304; MR compatibility per ASTM F2503; biocompatibility per ISO 10993-1; sterilization validation per ISO 22441; electrical safety and EMC per IEC 60601-1 and IEC 60601-1-2.

The SCOUT MD Surgical Guidance System is substantially equivalent to predicate device K231468 because it has identical indications for use, intended use, mechanism of action, materials, and system components. The two modifications—MR Conditional labeling and additional sterilization options—do not impact the fundamental performance or safety of the device and therefore do not affect substantial equivalence.