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)
Shenzhen Sanping Image Technology Co., Ltd.The Bronchoscope System by Shenzhen Sanping Image Technology Co. is a single-use flexible bronchoscope designed for use in hospital environments for adult patients. It works with an electronic endoscope imaging processor that captures images inside the airways and tracheobronchial tree using a CMOS image sensor and LED light source, then processes and displays these images on a monitor. This system helps clinicians perform endoscopic diagnosis and treatments safely and effectively with single-use, sterile instruments to reduce infection risks.
Intended Use
The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.
Technology
The device uses a flexible single-use bronchoscope with a distal tip LED cold light source and CMOS image sensor to capture images inside the body. The electronic processor encodes and processes RGB video signals, controlling LED brightness and outputting image data to a monitor for real-time visualization during endoscopy.
Performance
Non-clinical tests demonstrated compliance with electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366-1), biocompatibility (ISO 10993 series), and sterilization standards (ISO 11135 and ISO 11607). System performance tests verified deflection, flexing, imaging parameters (signal-to-noise, field of view, distortion), and image quality, confirming safety and substantial equivalence without clinical testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/10/2024
8 months - 2
FDA Approval
3/14/2025
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