EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
Olympus Medical Systems Corp.The EVIS EXERA III Bronchovideoscope series from Olympus Medical Systems Corp. includes several bronchoscopic models designed to provide high-quality endoscopic imaging within the airways and tracheobronchial tree. Integrated with Olympus video system centers, these bronchoscopes allow clinicians to perform diagnosis and endoscopic surgery with advanced imaging modes including Narrow Band Imaging (NBI), Red Dichromatic Imaging (RDI), Texture and Color Enhancement Imaging (TXI), and Blue Light Imaging - Multi-wavelength Active Light (BAI-MAC). The devices offer improved image quality, high resolution, and features such as pre-freeze and automatic brightness adjustment. They are compatible with EndoTherapy accessories for biopsy and treatment. These devices facilitate better visualization and maneuverability for clinicians during bronchoscopy procedures.
Intended Use
The EVIS EXERA III Bronchovideoscope devices are intended for use with Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Technology
The devices comprise three parts: control section with angulation knobs, insertion section with image guide, light guides, and instrument channel, and connector section interfacing with video system. They incorporate Voice Coil Motor for dual focus, support imaging modalities including WLI, NBI, RDI, TXI, BAI-MAC, and features such as pre-freeze and automatic brightness adjustment. Compatible with EndoTherapy accessories for biopsy and other procedures.
Performance
Bench testing included evaluations of thermal safety, photobiological safety, color performance, resolution, noise and dynamic range, image uniformity, video latency, and specific imaging modes (RDI, TXI, BAI-MAC). Ignition factors safety studies conducted for laser, high-frequency, APC systems. Animal testing assessed imaging modes. Risk management followed ISO 14971:2019. Software, sterilization, biocompatibility and clinical tests were not performed due to no major changes from predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/21/2025
3 months - 2
FDA Approval
6/23/2025
Other devices from Olympus Medical Systems Corp.
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