NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)

The NanoKnife System is a software-controlled low-energy direct-current generator that surgically ablates soft tissue, including prostate tissue, using irreversible electroporation (IRE). High-voltage electrical pulses are delivered between pairs of probes placed in an array within tissue, causing cell death. The system includes a generator, single electrode activation probes (15 cm and 25 cm variants), and an optional probe spacer.

The proposed NanoKnife System has identical technological characteristics to the predicate device and is unchanged from the currently cleared version. It remains a software-controlled low-energy direct-current generator with adjustable voltage waveforms, user-selectable parameters (volts/cm, pulse length, pulse count, probe distance, timing mode), and capacity for up to six probes in an array configuration.

ISO 14155:2020 – Clinical Investigation of Medical Devices for Human Subjects and Good Clinical Practice standards were applied during the PRESERVE clinical study for protection of human subjects and archiving of essential documents.

The device is substantially equivalent because it is technologically identical to the predicate NanoKnife System (K183385) with no design changes. The proposed modification only adds specificity to the indications by explicitly stating 'including prostate tissue' rather than claiming a new use. This specificity is supported by the PRESERVE clinical trial, which demonstrated safety and effectiveness comparable to the predefined performance goal (71.1% negative biopsy rate at 12 months vs. 52% goal; 86% of subjects experienced adverse events, with only three grade 3 events and no grade 4–5 events related to the procedure). Since the technology, design, and mechanism of action remain unchanged and clinical data validates the new tissue application, substantial equivalence is established.