| K-number | K250434 |
| Device name | trophon2 |
| Applicant | Nanosonics |
| Product code | OUJ |
| Device class | Class II |
| Decision date | Aug 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1570 |
The trophon2 is a software-controlled high-level disinfection device that sterilizes ultrasound transducers using hydrogen peroxide mist. Pre-cleaned and dried ultrasound probes are placed in a sealed chamber where a nebulizer generates a controlled mist that contacts the probe surface for a specified time, temperature, and dosage to achieve germicidal efficacy. The device is suitable for use in hospitals and healthcare facilities by trained personnel.
The subject device uses the same operating principle, disinfectant (trophon Sonex-HL at 35% hydrogen peroxide), delivery mechanism (liquid aerosol mist), and removal process (automated aeration) as the predicate. Both employ software-controlled systems with identical chamber design, temperature control (56°C minimum), automated process monitoring, RFID traceability, color touch screen interface, and multiple software/firmware components on two PCBAs. The key difference is a reduced minimum operational cycle time of 4 minutes versus 7 minutes in the predicate.
Non-clinical testing employed AOAC methods (6.3.06:2012 for mycobactericidal, 6.3.02:2006 for fungicidal, 6.2.02/6.2.03/6.2.05:2006 for bactericidal efficacy), ASTM E1837-96(2014) for simulated use, and device performance standards including IEC 61010-1, IEC 61010-2-040, IEC 62304, ISO 62366-1 and -2, ISO 10993-1, ISO 14971, and IEC 60601-1-2 Edition 4.1 2020-09.
Substantial equivalence is established through identical intended use, operating principle, disinfectant chemistry, delivery and removal mechanisms, and software architecture to the predicate device K173865. The same comprehensive non-clinical testing protocol—including efficacy studies, critical process parameter validations, chamber venting, chemical indicator performance, residual testing, and leak testing—was successfully completed using identical acceptance criteria. The only modification is an improved cycle time (4 versus 7 minutes), which represents an enhancement rather than a meaningful difference in technological characteristics or safety and effectiveness.
View the full FDA submission: accessdata.fda.gov