Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

The Bronchoscope System is a single-use flexible bronchoscope with six model variants (SP-Y-ZQGJ2.8 through SP-Y-ZQGJ5.8) paired with a reusable Electronic Endoscope Imaging Processor (SP-TXCLQ12.1). The device is designed for endoscopic diagnosis or treatment within the airways and tracheobronchial tree in adult patients in hospital settings. It uses an LED light source and CMOS image sensor at the distal tip, with the processor controlling brightness and transmitting video to a monitor.

The proposed device uses identical optical components and arrangement at the distal tip across all models, with a flexible scope design, internal LED light source, and forward-viewing CMOS imaging. Working length is 650mm (slightly longer than the 600mm predicate). Distal end outer diameter is ≤2.9mm (8.7 Fr) with up/down deflection of 180° (±10% tolerance), matching the predicate. The device is sterilized with ethylene oxide to SAL 10⁻⁶ and is single-use.

IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-2-18:2009 (endoscopic equipment), IEC 60601-1-6:2010 (usability), IEC 62471:2006 (photobiological safety), ISO 10993 series (biocompatibility), ISO 11607-1:2019 (packaging), and ISO 11135:2014 (ethylene oxide sterilization). Performance testing included deflection, flexing, water supply, sealing, field of view, geometric distortion, signal-to-noise ratio, and color performance validation.

The device is substantially equivalent because it shares the same intended use (airways/tracheobronchial endoscopy in adults), same classification (Class II flexible bronchoscope), same technology (CMOS sensor with LED illumination), and same design principles as the predicate devices. Minor mechanical specification differences (e.g., 650mm vs. 600mm working length, slight diameter variations) do not raise safety or effectiveness concerns because the device falls within established clinical practice parameters and all performance testing met standard requirements. The device complies with identical regulatory standards and biocompatibility requirements as the predicate, with no new materials or design features that would affect safety profile.