DFVision® 3D Electronic Laparoscope


Product NameDFVision® 3D Electronic Laparoscope
ClassificationClass III
Approval Date6/04/2021
Review DivisionCenter for Medical Device Evaluation of NMPA
Applicant NameMicroPort Group
Registration PathwayDomestic Device
Innovation Pathway
Product DescriptionThe product consists of laparoscopic lens end, laparoscopic tube, laparoscopic box, and communication fiber.
Indications for UseThis 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 TestingThe 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  

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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.  

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Product Risk/Benefit AnalysisThis 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.  

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