UV Smart D60

The UV Smart D60 is a chemical-free ultraviolet-C (UV-C) disinfection chamber designed to achieve high-level disinfection of external surfaces of Transesophageal Echocardiogram (TEE) probes without lumens or indentations deeper than their widths. It operates in healthcare facilities with a fixed 120-second disinfection cycle and uses eight UV-C lamps with reflective chamber walls to suspend and disinfect instruments.

The UV Smart D60 features a dual-sensor independent monitoring system (photodiode for UV-C dose and current sensor for power consumption) compared to the predicate's multiple photodiode sensors. It uses a fixed 120-second cycle versus the predicate's variable-duration cycles, accommodates entire instruments including cables within the chamber, requires no ventilation with temperature monitoring, and provides detailed traceability reports on its touchscreen interface.

IEC 61326-1 (electromagnetic compatibility), IEC 60601-1-2 (medical electrical equipment EMC), IEC 61010-1 and IEC 61010-2-040 (electrical safety), IEC 60601-2-37 (ultrasound probes temperature), IEC 60601-2-18 (endoscopic equipment temperature), ISO 10993-1 (biocompatibility), and FDA guidance documents on device software and cybersecurity.

The UV Smart D60 is substantially equivalent to the Germitec Chronos predicate because both are Class II UV-C disinfection chamber devices with identical product codes and regulatory classifications. Although differences exist in intended load (TEE probes vs. ultrasound probes), cycle operation (fixed vs. variable), and monitoring systems, comprehensive nonclinical testing including potency, simulated use, optical verification, and in-use testing demonstrates the device achieves equivalent safety and effectiveness for high-level disinfection of medical instruments.