HJY VisualNext 3D Endoscopic Vision System
HJY Smart Medical Device Co., Ltd.The HJY VisualNext 3D Endoscopic Vision System is a medical device designed to provide surgeons with a 3D visual of internal surgical sites during neurological, spinal, and general surgeries. It uses dual CMOS sensors and integrated LED lighting to capture and display high-resolution 3D images on an external monitor, helping clinicians better visualize the surgical area for improved precision and outcomes.
Intended Use
HJY VisualNext 3D Endoscopic Vision System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.
Technology
The system consists of an Endoscope Control Unit (ECU) and a rigid metal endoscope with 2 LED lamps and a CMOS camera with 2 sensors, connected by coaxial cable to the ECU. The dual sensors capture images that are processed and displayed on an external monitor in 2D and 3D. The ECU is not internet-connected. The endoscope has an insertion tube working length of 180 mm and outer diameter of 7.0 mm, and images are recordable and markable.
Performance
Non-clinical testing included bench testing and animal studies demonstrating consistent image quality, safety, and effectiveness. The device met predefined acceptance criteria for image resolution, field of view, illumination, and other quality metrics comparable to the predicate device. Animal testing in a porcine model confirmed the 3D visualization superiority compared to the 2D predicate device. Software validation, sterility, biocompatibility, electromagnetic compatibility, and photobiological safety tests were also successfully conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/5/2024
6 months - 2
FDA Approval
5/21/2025
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