swiftPro System (SWF-SPS); Swift System (SWF-SYS)

The Swift System and swiftPro System are microwave-based devices that deliver energy through a surface contact applicator to coagulate (ablate) soft tissue during non-invasive procedures. Both systems are specifically indicated for the treatment of common and plantar warts and are not indicated for use on genital warts or in cardiac procedures.

Both the Swift and swiftPro Systems are identical to their predicate devices in design, materials, and operation. They use microwave energy (0-10W in increments), operate with the same power delivery mechanism, have identical applicator tips with ceramic waveguides and disposable silicone barriers, and deliver the same 10 J/mm² energy density. The only modification was a minor addition of a screened loom to the Swift device to ensure continued EMC compliance with updated standards.

IEC 60601-1:2005 + AMD1:2012+AMD2:2020 (medical electrical equipment general requirements), IEC 60601-2-6:2012 + AMD1:2016 (microwave therapy equipment), IEC 60601-1-2:2014 +AMD1:2020 (electromagnetic disturbances), ISO 10993 (biocompatibility testing), IEC 62304:2006 (software validation), ANSI/AAMI HE75:2009, IEC 60601-1-6:2010, and IEC 62366-1:2015 (human factors and usability).

The subject devices are substantially equivalent because they maintain identical technological characteristics, design, principles of operation, and materials to their predicate devices (Swift K181941 and swiftPro K240518). The only change is the addition of a specific indication for common and plantar warts, which is supported by a pivotal clinical study demonstrating comparable safety and effectiveness to cryotherapy. A minor EMC compliance modification was implemented, and the clinical functionality of tissue coagulation delivery remains unchanged. No new risks were identified, and the device performances are identical across all measured parameters.