1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality

The 1688 and 1788 4K Camera Systems with Advanced Imaging Modality are endoscopic camera systems that produce live video during surgical procedures. The 1688 is sensitive to visible white light and infrared; the 1788 adds short blue spectrum sensitivity. Both systems consist of a camera control unit, camera head, and coupler for attaching endoscopes, and are indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, spine surgery, and plastic surgery in adults and pediatric patients.

Both subject devices use CMOS image sensors with digital image processing to produce 4K resolution video (up to 3840 x 2160) at 60 frames per second. The 1688 offers white light, near-infrared fluorescence, and near-infrared transillumination imaging modes; the 1788 adds narrow band illumination. Both are compatible with endoscopes conforming to ISO/TS 18339 and operate via alternate or simultaneous frame processing. All specifications are identical to the predicate devices.

IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18, IEC 60601-1-2, IEC 60601-4-2, and ISO/TS 18339.

The devices are substantially equivalent because they have identical technological characteristics, components, intended use, imaging modes, and safety standards as their predicate devices (K240174 and K233327). The only modification is the addition of 'spine surgery' to the indications for use, which the applicant argues does not introduce new risks since spine surgery is a sub-specialty of the previously cleared neurosurgery indication and specific spine procedures were already included in the predicate indications. No design changes or additional testing were needed, and the overall risk profile remains unchanged.