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))
Scivita Medical Technology Co.,Ltd.The Broncho Videoscope System from Scivita Medical Technology Co. consists of single-use bronchoscopes and endoscopic image processors designed for endoscopic diagnosis and treatment within the respiratory system, including the trachea, bronchi, and lungs. This system provides real-time visualization on monitors, enabling clinicians to observe, diagnose, and treat respiratory conditions effectively in hospital settings.
Intended Use
The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Single-use Broncho Videoscope is used in conjunction with image processors to provide images for observation, diagnosis, photography, and treatment of the respiratory system.
Technology
The system includes a single-use bronchoscope and image processors (Full HD Visualization and standard Endoscopic Image Processor) that display images from electronic endoscopes on monitors, enabling real-time visualization within the body cavity. Models differ mainly in size and image adjustment functions.
Performance
Biocompatibility tests including cytotoxicity, sensitization, and irritation were conducted per ISO 10993-1 standards. Results showed compliance, demonstrating the device's safety and substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/24/2025
1 month - 2
FDA Approval
3/19/2025
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