HJY VisualNext 3D Endoscopic Vision System

The HJY VisualNext 3D Endoscopic Vision System is a rigid endoscope with integrated LED lighting and a dual-sensor CMOS camera for viewing internal surgical sites during general surgery, neurosurgery (brain procedures), and spinal surgery (nucleotomy, discectomy, foraminotomy). The endoscope connects via coaxial cable to a control unit that processes and displays images on an external monitor; images are recordable and markable for analysis.

The subject device has two key differences from its 2D predicate device: it provides 2D and 3D imaging capability (predicate offers 2D only) using dual sensors instead of one, and it has a larger insertion tube outer diameter of 7.0 mm versus 5.0 mm. All other specifications—LED light source, rod lens optics, 120° field of view, 5–100 mm depth of field, 800×800 pixel optical resolution, 180 mm working length, and single-use design—remain identical.

Testing followed FDA guidance documents on sterility (Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile) and biocompatibility (Use of ISO 10993-1). Electromagnetic compatibility, thermal safety, and photobiological safety were tested per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 62471. Software validation followed FDA guidance on device software functions.

The subject device's 3D imaging capability and slightly larger diameter do not raise different safety or effectiveness questions because bench testing and animal studies (porcine brain and spine procedures) demonstrated that image quality parameters—resolution, illumination, color representation, contrast, and noise—met predefined acceptance criteria and were comparable to the 2D predicate device. Both aged and non-aged subject devices maintained consistent performance throughout shelf life. The identical intended use, similar technological fundamentals (same light source, optics, resolution, and dimensions except diameter), and passing performance tests across all safety and efficacy metrics establish that the technological differences are not material to safety or effectiveness.