| Product Name | DFVision® 3D Electronic Laparoscope |
| Classification | Class III |
| Approval Date | 6/04/2021 |
| Review Division | Center for Medical Device Evaluation of NMPA |
| Applicant Name | MicroPort Group |
| Registration Pathway | Domestic Device Innovation Pathway |
| Product Description | The product consists of laparoscopic lens end, laparoscopic tube, laparoscopic box, and communication fiber. |
| Indications for Use | This product is used in conjunction with model MVS-1080 endoscopic image processor to provide images via a video monitor for thoracic and abdominal observation, diagnosis, photography, or treatment. |
| Summary of Non-Clinical Testing | The applicant submitted the following non-clinical research materials: · Product performance research · Biocompatibility · Sterilization · Product shelf-life and packaging · Environmental testing · Safety index of active equipment Contact us to learn more about how to prepare the non-clinical study of this type of product |
| Summary of Clinical Evaluation | · Clinical pathway: CER pathway Select the 3D electronic laparoscope and 3D HD electronic laparoscope as predicates. The registrant submitted a comprehensive comparison in terms of basic principle, structural composition, and scope of application and provided test comparison reports in terms of performance parameters, safety and effectiveness analysis reports of difference parts, experimental animal data, clinical literature, and clinical data of predicates to prove the safety and effectiveness of the product. Contact us to learn more about the clinical evaluation of this type of product |
| Product Risk/Benefit Analysis | This product is a 3D Electronic Laparoscope, which can provide observation and imaging of human thorax and abdominal cavity, and provide three-dimensional images for doctors in the process of operation, so that the operations of tissue grasping, anatomy, separation, hemostasis, suture and anastomosis can be easily realized. If not handled properly, the Laparoscope may pose a risk. For example, it will cause mechanical damage to human tissues, and doctors with 3D vertigo may feel visual fatigue or dizziness during surgery. In addition, special attention should be paid to warnings and precautions, and contraindications of the product. Contact us to learn more about the risk/benefit analysis of this type of product |
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