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  1. <!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>
  2. <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  3. <ul>
  4. <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">&nbsp;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>&nbsp;Microwave Ablation Device</li>
  5. <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>&nbsp;&nbsp;Exceed S10E</li>
  6. </ul>
  7. <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  8. <p><span style="font-family:Times New Roman,Times,serif"><span style="font-size:16px">&nbsp; &nbsp; &nbsp; &nbsp;</span></span>69356506PMA0270NL</p>
  9. <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  10. <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</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>
  11. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>&nbsp;</strong></span></span></strong></span></span></h2>
  12. <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span>The device is intended to be used by trained and qualified medical professionals and nurses.</p>
  13. <p>&nbsp;</p>
  14. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  15. <ul>
  16. <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>
  17. </ul>
  18. <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span>The device is intended to be used for patients that age ≥ 18 years old.</p>
  19. <ul>
  20. <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>
  21. </ul>
  22. <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span>Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. Microwave Ablation System is not intended for cardiac use.</p>
  23. <ul>
  24. <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>
  25. </ul>
  26. <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span></p>
  27. <ul>
  28. <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>
  29. </ul>
  30. <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.
  31. 2. The document does not specify any classification of accessories or principles of classification.
  32. 3. The document states that it is part of the development stage for the software. There is no mention of packaging with the device.
  33. <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>
  34. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  35. <p>The device is intended to be used in the following environments:
  36. a) Care area where the device will be used:
  37. If home use, Any risks such as such as needle stick injuries?</p>
  38. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  39. <p style="text-align:justify"><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span>Refer to Device Description File</p>
  40. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  41. <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>
  42. <p style="text-align:justify">&nbsp;</p>
  43. <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  44. <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&nbsp;included</strong></span></span></span></strong></span></span></p>
  45. <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>
  46. <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>
  47. <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>
  48. <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>
  49. <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>
  50. <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>
  51. <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>
  52. <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>
  53. <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>&nbsp;Accessories not included but necessary for use</strong></span></span></span></strong></span></span></p>
  54. <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>
  55. <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>
  56. <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>
  57. <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>
  58. <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>
  59. <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>
  60. <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>
  61. <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>&nbsp;<span style="font-family:Times New Roman,Times,serif">with it</span></strong></span></span></span></strong></span></span></p>
  62. <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>
  63. <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>
  64. <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>
  65. <table style="border-collapse: collapse;" align="center" cellspacing="0" class="MsoTableGrid" style="border-collapse:collapse; border:none; font-family:&quot;Times New Roman&quot;; font-size:13px; width:97.6600%">
  66. <tbody>
  67. <tr>
  68. <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:225px">
  69. <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>
  70. </td>
  71. <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">
  72. <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>
  73. </td>
  74. <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">
  75. <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>
  76. </td>
  77. <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">
  78. <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>
  79. </td>
  80. </tr>
  81. <tr>
  82. <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">
  83. <p style="text-align:center"><span style="font-size:14pt"><span style="font-family:Univers">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></span></p>
  84. </td>
  85. <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">
  86. <p style="text-align:center">&nbsp;</p>
  87. </td>
  88. <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">
  89. <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>
  90. </td>
  91. <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">
  92. <p style="text-align:center">&nbsp;</p>
  93. </td>
  94. </tr>
  95. <tr>
  96. <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">
  97. <p style="text-align:center">&nbsp;</p>
  98. </td>
  99. <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">
  100. <p style="text-align:center">&nbsp;</p>
  101. </td>
  102. <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">
  103. <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>
  104. </td>
  105. <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">
  106. <p style="text-align:center">&nbsp;</p>
  107. </td>
  108. </tr>
  109. </tbody>
  110. </table>
  111. <p>&nbsp;</p>
  112. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  113. <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>
  114. <p style="text-align:justify"><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span> Refer to Device Description File</p>
  115. <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>
  116. <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>
  117. <p>&nbsp;</p>
  118. <ul>
  119. <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>&nbsp;</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>&nbsp;<span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span>Microwave Ablation Device Embedded software</li>
  120. <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>&nbsp;</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>&nbsp;<span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</span></span></strong>Exceed S V1&nbsp;</li>
  121. <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">&nbsp;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">&nbsp;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>&nbsp;</strong>&nbsp;</li>
  122. </ul>
  123. <p><span style="font-family:Times New Roman,Times,serif"><span style="background-color:#ffff00; font-size:16px">&nbsp;</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>
  124. <ul>
  125. <li><strong><span style="font-size:12.0000pt"><span style="font-family:'Times New Roman'"><span style="color:#000000">Software Structure &amp; 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>
  126. </ul>
  127. <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>
  128. <p>&nbsp;</p>
  129. <p>&nbsp;</p>
  130. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>&nbsp;</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>
  131. <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>
  132. <p>&nbsp;</p>
  133. <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>
  134. <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>&nbsp;<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>
  135. <p>&nbsp;</p>
  136. <h2 style="margin-left:30px"><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  137. <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>
  138. <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">&nbsp;<span style="font-family:Times New Roman,Times,serif">are shown in the table 4 below:</span></span></span></p>
  139. <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>
  140. <table style="border-collapse: collapse;" cellspacing="0" class="Table" style="border-collapse:collapse; border:none; font-family:&quot;Times New Roman&quot;; font-size:13px; margin-left:9px; margin-right:9px; width:98%">
  141. <tbody>
  142. <tr>
  143. <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">
  144. <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>
  145. </td>
  146. <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">
  147. <p style="text-align:center">&nbsp;</p>
  148. </td>
  149. <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">
  150. <p style="text-align:center">&nbsp;</p>
  151. </td>
  152. <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">
  153. <p style="text-align:center">&nbsp;</p>
  154. </td>
  155. <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">
  156. <p style="text-align:center">&nbsp;</p>
  157. </td>
  158. <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">
  159. <p style="text-align:center">&nbsp;</p>
  160. </td>
  161. <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">
  162. <p style="text-align:center">&nbsp;</p>
  163. </td>
  164. <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">
  165. <p style="text-align:center">&nbsp;</p>
  166. </td>
  167. <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">
  168. <p style="text-align:center">&nbsp;</p>
  169. </td>
  170. </tr>
  171. <tr>
  172. <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">
  173. <p style="text-align:center">&nbsp;</p>
  174. </td>
  175. <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">
  176. <p style="text-align:center">&nbsp;</p>
  177. </td>
  178. <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">
  179. <p style="text-align:center">&nbsp;</p>
  180. </td>
  181. <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">
  182. <p style="text-align:center">&nbsp;</p>
  183. </td>
  184. <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">
  185. <p style="text-align:center">&nbsp;</p>
  186. </td>
  187. <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">
  188. <p style="text-align:center">&nbsp;</p>
  189. </td>
  190. <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">
  191. <p style="text-align:center">&nbsp;</p>
  192. </td>
  193. <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">
  194. <p style="text-align:center">&nbsp;</p>
  195. </td>
  196. <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">
  197. <p style="text-align:center">&nbsp;</p>
  198. </td>
  199. </tr>
  200. </tbody>
  201. </table>
  202. <p>&nbsp;</p>
  203. <h2><span style="font-size:16pt"><span style="font-family:&quot;Univers (W1)&quot;"><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>
  204. <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>
  205. <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>
  206. <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">&nbsp;is a new product that has not been on any market around the world.</span></span></span></span></span></p>
  207. <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>
  208. <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>
  209. <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>
  210. <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>
  211. <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>
  212. <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>
  213. <p>&nbsp;</p>
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