4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)

The 4K UHD Endoscopy Camera System (models KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) converts optical signals from an endoscope into electronic signals for display on a monitor. It is used with an optical endoscope, cold light source, and monitor for both diagnostic and therapeutic endoscopic procedures in professional healthcare settings by qualified medical personnel.

The proposed device uses a single 1/3-inch CMOS image sensor with 16:9 aspect ratio and 4K UHD resolution (3840×2160 pixels), compared to the predicate's three 1/3-inch sensors supporting both 3840×2160 and 4096×2160 resolutions. The proposed device has a lower operating temperature range (+5°C to +40°C vs. +10°C to +40°C), improved water protection for the camera head (IPX8 vs. IPX7), and includes DVI connectivity not present in the predicate. Both are reusable, multi-patient use devices with comparable overall architecture and interface connectivity.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-2-18 (endoscopic equipment), IEC 60601-1-6 (usability), IEC 60601-1-2 (electromagnetic disturbances), IEC TS 60601-4-2 (electromagnetic immunity guidance), AAMI ST98:2022 (cleaning validation), and ISO 17664-1:2021 (processing of reusable medical devices).

The proposed device is substantially equivalent because it has the same indications for use, identical principle of operation using CMOS sensors to convert optical to electronic signals, same regulatory class and name, comparable structure and composition, and meets the same performance standards as the predicate. Technological differences such as single vs. triple sensors, resolution options, operating temperature range, and water protection do not raise different questions of safety and effectiveness, and non-clinical testing demonstrates the device is as safe and effective as the predicate.