Recently, the "computer aided detection software for colorectal polyps" is approved for marketing by NMPA in China, which is an innovative product of Chengdu Wision Medical Device Co., LTD.

This product is provided in CD form and installed and used in stand-alone mode. It has 9 functional modules: acquisition card management, authorization management, drawing detection area, sound prompt, display option, displaying software information, monitoring running time, processing algorithm management and main program. The product is intended to be used in conjunction with designated models of video colonoscopes only in medical facilities to enable physicians to review the identified areas of suspect polyps presented in real time on the output stand-alone video images during colonoscopy in adults. The information is for reference only and physicians should make their own clinical judgment in combination with the patient's conditions.

The working principle of this product is to import video images at the video signal output port of endoscopic image processor, identify the areas of suspect polyps after software processing and algorithm analysis, and present it in a separate display. The product is the first medical device software in China that uses deep learning model to assist in the detection of polyps in endoscopic images. Small sample deep learning technology  and local labeling technology are used to select and develop the algorithm model framework. The overall performance of the algorithm is not completely subject to the increase of training data and can achieve high performance, strong generalization and robustness in small samples.

This product is applied with electronic colonoscopes to help physicians identify the areas of suspect polyp during colonoscopy examination, which is conducive to earlier detection of precancerous lesions of rectal cancer, thereby reducing the incidence and mortality of rectal cancer.

NMPA will protects the public health by strengthening the post-marketing supervision to assure the quality, safety and effectiveness of this product

Attachment: Innovative Medical Devices Approved by NMPA (to be translated)

(8/3/2022)

近日，国家药品监督管理局经审查，批准了成都微识医疗设备有限公司生产的“肠息肉电子结肠内窥镜图像辅助检测软件”创新产品注册申请。

该产品以光盘形式提供，以单机方式安装使用。具有采集卡管理、授权管理、绘制检测区域、声音提示、显示选项、显示软件信息、监测运行时间、处理算法管理、主程序9大功能模块。产品仅在医疗机构内与指定型号的电子结肠内窥镜配合使用，供执业医生在成人结肠内窥镜检查时，对输出的独立视频图像进行实时显示疑似息肉区域。该信息仅供参考，医生应当结合患者病情进行临床决策。

该产品工作原理为在内窥镜图像处理器的视频信号输出端口导入视频图像，经过软件处理和算法分析后找出其中疑似息肉的位置，并在单独的显示器中显示。该产品为国内首个利用深度学习技术对内窥镜图像中息肉进行辅助检测的医疗器械软件，采用了小样本深度学习技术和局部标记技术进行算法模型框架的选择和开发，算法的整体性能不完全依赖训练数据的增加，能够在较小样本下实现高性能、强泛化性和鲁棒性。

该产品与电子结肠内窥镜配合使用，可帮助医生在进行结肠镜检查时找出疑似息肉位置，有利于更早发现直肠癌的癌前病变，从而降低直肠癌发生率和死亡率。

药品监督管理部门将加强该产品上市后监管，保护患者用械安全。

附件：国家药监局已批准的创新医疗器械

(2022-08-03)