LumiRex Bronchoscope
Contra Healthcare Solutions, LLCThe LumiRex Bronchoscope is a single-use flexible endoscope designed to provide real-time video imaging of the airways and tracheobronchial tree. It aids clinicians during endoscopic procedures by allowing visualization through a thin tube equipped with a camera and light source. The device can operate in wired or wireless modes, enabling easier maneuverability, and is designed for use in hospitals.
Intended Use
The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment.
Technology
The device comprises a flexible thin tube with integrated light source and camera for real-time visualization, equipped with a working channel for instruments. It supports wired and wireless operation via adapters that transmit images to a video processor unit, providing image control, recording, and export capabilities. Wireless mode includes battery power and maintains low latency comparable to wired mode.
Performance
Extensive non-clinical validation including sterilization, biocompatibility, software verification, cybersecurity, electrical safety, electromagnetic compatibility, wireless latency, and bench testing for mechanical and optical performance was conducted. Testing confirmed safety and effectiveness in compliance with relevant standards, demonstrating substantially equivalent performance to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/15/2024
5 months - 2
FDA Approval
4/30/2025
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