Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.

The Insighters Single-use Bronchoscope System is a flexible video bronchoscope designed for observation, diagnosis, and treatment of the trachea, bronchus, and lung area. It consists of three single-use bronchoscope models (iS-B12A, iS-B22A, iS-B26A) in different sizes and a reusable Insight Workstation display unit. The device is for in-hospital use by trained clinicians and is sterilized by ethylene oxide for single use only.

The proposed device uses LED cold light illumination and a CMOS image sensor at the distal end to capture and transmit images. Key differences from the predicate include: slightly larger outer diameter (5.0–6.5 mm vs. 4.3–6.3 mm) but wider working channels (2.0–3.0 mm inner diameter), a larger field of view (90° vs. 85°), higher display resolution (1920×1080 vs. 800×480), and modern connection ports (Type-C, HDMI). Both use the same 180° bending capability and 600 mm working length.

IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18 for electrical safety and electromagnetic compatibility; ISO 8600 series for optical performance; EN ISO 10993-1, 10993-5, 10993-10, 10993-23, and 10993-11 for biocompatibility; ethylene oxide sterilization to SAL 1.0×10⁻⁶.

Substantial equivalence is established through identical indications for use, patient population, hospital environment, scope type, working length, illumination method, sterilization approach, and shelf life (3 years). Although the proposed device has a slightly larger outer diameter and wider working channel, the applicant argues that safety is not determined by outer diameter alone but by overall design and construction; the larger channel actually provides clinical convenience without compromising safety or effectiveness. Non-clinical performance testing, biocompatibility testing, and comparative image quality testing with the predicate all demonstrated equivalent safety and effectiveness, supporting the conclusion that dimensional and display differences do not affect the device's fundamental performance or safety profile.