Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

The Broncho Videoscope System is a single-use bronchoscope combined with an endoscopic image processor for visualization during respiratory procedures. It is designed for endoscopic diagnosis and treatment of the trachea, bronchi, and lungs in hospital environments, providing real-time video images for observation, diagnosis, photography, and therapeutic intervention.

The subject device has the same technical characteristics, specifications, designed structure, and materials as the predicate device. It includes six models of single-use videoscopes available in three outer diameters (2.8mm, 4.2mm, 5.6mm), with two material types (Nylon and PEEK) and two plug types, paired with either Full HD or standard endoscopic image processors.

ISO 10993-1 (biocompatibility framework), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation). Biocompatibility testing was performed by NAMSA (models with '-B' suffix) and WuXi Apptec Suzhou (models with '-P' suffix), both with ASCA accreditation for the relevant test methods.

The subject device is substantially equivalent because it has identical indications for use, the same technical specifications and design as the predicate, and newly conducted biocompatibility testing (cytotoxicity, sensitization, irritation) demonstrates compliance with ISO 10993 standards. The retest was performed to address biocompatibility data requirements while maintaining the same functional design, materials, and intended purpose as the legally marketed predicate device.