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- <!DOCTYPE html><html><head><meta charset="UTF-8"></head><body><p class="header1"></p> <div class="template-textarea"><div class="rich-editor"><p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>Chapter 2 Device Description</strong></span></span></strong></span></span></p>
- <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>2</strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>.1 Device Name</strong></span></span></strong></span></span></h2>
- <ul>
- <li><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:Times New Roman,Times,serif">Device</span></span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000"> Name</span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000">: </span></span></span></strong> Microwave Ablation Device</li>
- <li><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000">Device Model:</span></span></span></strong> Exceed S10E</li>
- </ul>
- <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2</span></strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>.</strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2 Basic UDI-DI(s)</span></strong></span></span></strong></span></span></h2>
- <p><span style="font-family:Times New Roman,Times,serif"><span style="font-size:16px"> </span></span>69356506PMA0270NL</p>
- <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.3 Intended purpose</span></strong></span></span></strong></span></span></h2>
- <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span>The microwave ablation system is indicated for soft tissue coagulation (ablation) in adults by healthcare professionals in healthcare facilities. Microwave Ablation System is not intended for cardiac use.</p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.4 Intended users</span> </strong></span></span></strong></span></span></h2>
- <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span>The device is intended to be used by trained and qualified medical professionals and nurses.</p>
- <p> </p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.6 </span><span style="font-family:Times New Roman,Times,serif">Intended patient population</span></strong></span></span></strong></span></span></h2>
- <ul>
- <li><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">Intended patient population</span></strong></span></span></strong></span></span></li>
- </ul>
- <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span>The device is intended to be used for patients that age ≥ 18 years old.</p>
- <ul>
- <li><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">Indications</span></strong></span></span></strong></span></span></li>
- </ul>
- <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span>Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. Microwave Ablation System is not intended for cardiac use.</p>
- <ul>
- <li><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">Con</span></strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>traindic</strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">ations</span></strong></span></span></strong></span></span></li>
- </ul>
- <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span></p>
- <ul>
- <li><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">Warning and Precautions</span></strong></span></span></span></strong></span></span></li>
- </ul>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[</span></span></span></span></span></span></span>1. The document describes the software requirements, configuration management plan, version control instruction, maintenance plan, architecture design, safety level, and detailed design for a microwave ablation device embedded software. It also includes a general description of the device, its software structure and function, and principle of operations.
- 2. The document does not specify any classification of accessories or principles of classification.
- 3. The document states that it is part of the development stage for the software. There is no mention of packaging with the device.
- <span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">]</span></span></span></span></span></span></span></p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.7 Intended conditions of use</span></strong></span></span></strong></span></span></h2>
- <p>The device is intended to be used in the following environments:
- a) Care area where the device will be used:
- If home use, Any risks such as such as needle stick injuries?</p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.8 Principles of operation</span></strong></span></span></strong></span></span></h2>
- <p style="text-align:justify"><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span>Refer to Device Description File</p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.9 </span><span style="font-family:Times New Roman,Times,serif">Explanation of any novel </span><span style="font-family:Times New Roman,Times,serif">feature</span><span style="font-family:Times New Roman,Times,serif">s</span></strong></span></span></span></strong></span></span></h2>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[Explanation of any novel features]</span></span></span></span></span></span></span></p>
- <p style="text-align:justify"> </p>
- <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.10 Description of the accessories for the device, other devices and other products which are intended to be used in combination with it</span></strong></span></span></strong></span></span></h2>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:'Times New Roman'"><strong>2.10.1 </strong></span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:'Times New Roman'"><strong>Accessories included</strong></span></span></span></strong></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[Accessories included]</span></span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">产品包装形式需要详细说明,包装材料,最小销售单元包装形式</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">与器械相关的任何附件</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">(</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">包括</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">I</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">类</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">)</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">应提供以下信息</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">:</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">附件</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">/</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">附件的简要描述,以及它们如何与器械一起使用</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">;</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">配件的分类和分类的原理</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">;</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">技术文档参考</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">(</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">文件名,问题状态,日期</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">)</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">明确说明附件是与器械一起包装的,还是单独提供的,还是两者都提供。同时说明附件是否已经认证,如果是,提供证书参考。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">请注意</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">(</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">如文件提交最佳实践指南所示</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">)</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">,技术文件中也应提供证据来证明器械与任何适用附件的兼容性。</span></span></span></span></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.10.2</span></strong></span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:'Times New Roman'"><strong> Accessories not included but necessary for use</strong></span></span></span></strong></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[Accessories not included but necessary for use]</span></span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">应标明器械中不包括但对其使用是必需的任何附件。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">与器械相关的任何附件</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">(</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">包括</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">I</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">类</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">)</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">应提供以下信息</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">:</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">附件</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">/</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">附件的简要描述,以及它们如何与器械一起使用</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">;</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">配件的分类和分类的原理</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">;</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">附件是否已经认证,如果是,提供证书参考。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">请注意</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">(</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">如文件提交最佳实践指南所示</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">)</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">,技术文件中也应提供证据来证明器械与任何适用附件的兼容性。</span></span></span></span></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.10.3 Intended to be used in </span><span style="font-family:Times New Roman,Times,serif">combination</span> <span style="font-family:Times New Roman,Times,serif">with it</span></strong></span></span></span></strong></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[Intended to be used in combination with it]</span></span></span></span></span></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">应补充兼容使用的医疗器械,接口信息要求,和硬件最低要求等;并引用相关兼容性测试方案</span><span style="font-family:Arial,Helvetica,sans-serif">/</span><span style="font-family:宋体">报告</span></span></span></span></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="font-family:Times New Roman,Times,serif">The compatibility test report for the combined use of the device is provided in the attachment.</span></span></span></span></span></p>
- <table style="border-collapse: collapse;" align="center" cellspacing="0" class="MsoTableGrid" style="border-collapse:collapse; border:none; font-family:"Times New Roman"; font-size:13px; width:97.6600%">
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- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>Document No.</strong></span></span></strong></span></span></p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:222px">
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>Document </strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">N</span></strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>ame</strong></span></span></strong></span></span></p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:86px">
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>Location</strong></span></span></strong></span></span></p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:86px">
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:10.5000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">File No.</span></strong></span></span></strong></span></span></p>
- </td>
- </tr>
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- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:225px">
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"> </span></span></p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:222px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:86px">
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="font-family:Times New Roman,Times,serif">Folder 6</span></span></span></span></span></p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:86px">
- <p style="text-align:center"> </p>
- </td>
- </tr>
- <tr>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:225px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:222px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:86px">
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="font-family:Times New Roman,Times,serif">Folder 6</span></span></span></span></span></p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:86px">
- <p style="text-align:center"> </p>
- </td>
- </tr>
- </tbody>
- </table>
- <p> </p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.11 General description of the key functional elements</span></strong></span></span></strong></span></span></h2>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.11.1 Device Description</span></strong></span></span></strong></span></span></p>
- <p style="text-align:justify"><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span> Refer to Device Description File</p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.11.2 </span><span style="font-family:Times New Roman,Times,serif">Software Description</span></strong></span></span></span></strong></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[Software Description]</span></span></span></span></span></span></span></p>
- <p> </p>
- <ul>
- <li><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:Times New Roman,Times,serif">Software</span></span></span></span></strong><strong> </strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:Times New Roman,Times,serif">Name</span></span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000">:</span></span></span></strong> <span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span>Microwave Ablation Device Embedded software</li>
- <li><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:Times New Roman,Times,serif">Software</span></span></span></span></strong><strong> </strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:Times New Roman,Times,serif">Version</span></span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000">:</span></span></span> <span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span></strong>Exceed S V1 </li>
- <li><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:Times New Roman,Times,serif">Software</span></span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000"> S</span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:Times New Roman,Times,serif">afety</span></span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000"> Classification</span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:宋体">:</span></span></span></span></strong><strong> </strong> </li>
- </ul>
- <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px"> </span></span>Class C: the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which results in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM and the resulting possible HARM is death or SERIOUS INJURY.</p>
- <ul>
- <li><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000">Software Structure & Function</span></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#000000"><span style="font-family:宋体">:</span></span></span></span></strong></li>
- </ul>
- <p style="text-align:justify"><img alt="" src="https://60.204.236.53:41404/download?filename=/vdb/www/raycos.com.cn/theme/m049/images/WPS%E5%9B%BE%E7%89%87(1).jpg"><img alt="" src="https://raycos.com.cn/theme/m049/images/funtion.jpg" style="height:508px; width:777px"></p>
- <p> </p>
- <p> </p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.13 </span><span style="font-family:Times New Roman,Times,serif">Worst case representative(s) of a product family</span></strong></span></span></span></strong><strong> </strong><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">and a description or complete list of various configurations / variants of the device that are intended to be made available to the market</span></strong></span></span></span></strong></span></span></h2>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[Worst case representative(s) of a product family and a description or complete list of various configurations / variants of the device that are intended to be made available to the market]</span></span></span></span></span></span></span></p>
- <p> </p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="font-family:Times New Roman,Times,serif">Model: </span></span></span><span style="font-size:12.0000pt"><span style="font-family:Arial"><span style="color:#ff0000">[</span></span></span><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">产品型号</span></span></span></span><span style="font-size:12.0000pt"><span style="font-family:Arial"><span style="color:#ff0000">]</span></span></span></span></span></p>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="font-family:Times New Roman,Times,serif">Rationale:</span></span></span> <span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">一般是风险最高的</span><span style="font-family:Arial,Helvetica,sans-serif">/</span><span style="font-family:宋体">配置最全的</span></span></span></span></span></span></p>
- <p> </p>
- <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.15 Full device specifications</span></strong></span></span></span></strong></span></span></h2>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[Full device specifications]</span></span></span></span></span></span></span></p>
- <p><span style="font-size:12.0000pt"><span style="font-family:宋体"><span style="font-family:Times New Roman,Times,serif">The specifications/models of the </span></span></span>Exceed S10E<span style="font-size:12.0000pt"><span style="font-family:宋体"> <span style="font-family:Times New Roman,Times,serif">are shown in the table 4 below:</span></span></span></p>
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>Table </strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">4 </span></strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><strong>Table of </strong></span></span></strong><strong><span style="font-size:12.0000pt"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">parameters of each model </span></strong></span></span></strong></span></span></p>
- <table style="border-collapse: collapse;" cellspacing="0" class="Table" style="border-collapse:collapse; border:none; font-family:"Times New Roman"; font-size:13px; margin-left:9px; margin-right:9px; width:98%">
- <tbody>
- <tr>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:115px">
- <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers"><strong><span style="font-size:10.5000pt"><span style="font-family:'Times New Roman'"><strong>Model Name</strong></span></span></strong></span></span></p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:67px">
- <p style="text-align:center"> </p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:78px">
- <p style="text-align:center"> </p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:72px">
- <p style="text-align:center"> </p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:87px">
- <p style="text-align:center"> </p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:52px">
- <p style="text-align:center"> </p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:51px">
- <p style="text-align:center"> </p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:64px">
- <p style="text-align:center"> </p>
- </td>
- <td style="background-color:#e7e6e6; border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:1px solid black; vertical-align:center; width:55px">
- <p style="text-align:center"> </p>
- </td>
- </tr>
- <tr>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:115px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:67px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:78px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:72px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:87px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:52px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:51px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:64px">
- <p style="text-align:center"> </p>
- </td>
- <td style="border-bottom:1px solid black; border-left:1px solid black; border-right:1px solid black; border-top:none; vertical-align:center; width:55px">
- <p style="text-align:center"> </p>
- </td>
- </tr>
- </tbody>
- </table>
- <p> </p>
- <h2><span style="font-size:16pt"><span style="font-family:"Univers (W1)""><strong><span style="font-size:12.0000pt"><span style="background-color:#ffff00"><span style="font-family:宋体"><strong><span style="font-family:Times New Roman,Times,serif">2.17 </span><span style="font-family:Times New Roman,Times,serif">An overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist</span></strong></span></span></span></strong></span></span></h2>
- <p><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:Arial,Helvetica,sans-serif">[An overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist]</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">所有提交的文件都应该附有市场历史,以便理解器械开发的背景。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">如果器械是新的,制造商从未在世界任何地方销售过,请明确说明。</span></span></span></span></span></span>Microwave Ablation Device<span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000"> is a new product that has not been on any market around the world.</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">对于现有器械</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">:</span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">•</span></span></span></span> <span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">确保提供市场历史,说明任何变更的性质和时间,以及任何相关文件</span><span style="font-family:Arial,Helvetica,sans-serif">(</span><span style="font-family:宋体">即风险分析、标签、临床评估报告、验证</span><span style="font-family:Arial,Helvetica,sans-serif">/</span><span style="font-family:宋体">验证数据等</span><span style="font-family:Arial,Helvetica,sans-serif">)</span><span style="font-family:宋体">说明这些变更。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">•</span></span></span></span> <span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">提供证据</span><span style="font-family:Arial,Helvetica,sans-serif">(</span><span style="font-family:宋体">例如,</span><span style="font-family:Arial,Helvetica,sans-serif">BSI</span><span style="font-family:宋体">以前评审的参考编号</span><span style="font-family:Arial,Helvetica,sans-serif">)</span><span style="font-family:宋体">以证明</span><span style="font-family:Arial,Helvetica,sans-serif">BSI</span><span style="font-family:宋体">已被通知所有重大变更</span><span style="font-family:Arial,Helvetica,sans-serif">(</span><span style="font-family:宋体">如果适用</span><span style="font-family:Arial,Helvetica,sans-serif">)</span><span style="font-family:宋体">。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">对于</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">MDR</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">下的初次申请,请确认该器械以前是否以</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">MDD</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">上市,以及与</span></span></span></span><span style="font-size:10.5000pt"><span style="font-family:Arial"><span style="color:#ff0000">MDD</span></span></span><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">认证的器械相比是否有任何变化</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">市场历史应包括欧盟和其他地区的批准。</span></span></span></span></span></span></p>
- <p style="text-align:justify"><span style="font-size:14pt"><span style="font-family:Univers"><span style="font-size:10.5000pt"><span style="font-family:宋体"><span style="color:#ff0000"><span style="font-family:宋体">如果器械是一个系统,请确保按器械部件和每年销售的器械数量进行分类</span></span></span></span></span></span></p>
- <p> </p>
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