Chapter 2 Device Description

## 2.1 Device Name

- Device Name: Microwave Ablation Device
- Device Model: Exceed S10E

## 2.2 Basic UDI-DI(s)

69356506PMA0270NL

## 2.3 Intended purpose

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.

## 2.4 Intended users

The device is intended to be used by trained and qualified medical professionals and nurses.

## 2.6 Intended patient population

- Intended patient population

The device is intended to be used for patients that age ≥ 18 years old.

- Indications

Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. Microwave Ablation System is not intended for cardiac use.

- Contraindications

- Warning and Precautions

[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. ]

## 2.7 Intended conditions of use

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?

## 2.8 Principles of operation

Refer to Device Description File

## 2.9 Explanation of any novel features

[Explanation of any novel features]

## 2.10 Description of the accessories for the device, other devices and other products which are intended to be used in combination with it

2.10.1 Accessories included

[Accessories included]

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

与器械相关的任何附件(包括I类)应提供以下信息:

附件/附件的简要描述，以及它们如何与器械一起使用;

配件的分类和分类的原理;

技术文档参考(文件名，问题状态，日期)。

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。

请注意(如文件提交最佳实践指南所示)，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。

2.10.2 Accessories not included but necessary for use

[Accessories not included but necessary for use]

应标明器械中不包括但对其使用是必需的任何附件。

与器械相关的任何附件(包括I类)应提供以下信息:

附件/附件的简要描述，以及它们如何与器械一起使用;

配件的分类和分类的原理;

附件是否已经认证，如果是，提供证书参考。

请注意(如文件提交最佳实践指南所示)，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。

2.10.3 Intended to be used in combination with it

[Intended to be used in combination with it]

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/报告

The compatibility test report for the combined use of the device is provided in the attachment.

Document No. | Document Name | Location | File No.
|  | Folder 6 |
|  | Folder 6 |

## 2.11 General description of the key functional elements

2.11.1 Device Description

Refer to Device Description File

2.11.2 Software Description

[Software Description]

- Software Name: Microwave Ablation Device Embedded software
- Software Version: Exceed S V1
- Software Safety Classification：

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.

- Software Structure & Function：

## 2.13 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

[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]

Model: [产品型号]

Rationale: 一般是风险最高的/配置最全的

## 2.15 Full device specifications

[Full device specifications]

The specifications/models of the Exceed S10E are shown in the table 4 below:

Table 4 Table of parameters of each model

Model Name |  |  |  |  |  |  |  |

## 2.17 An overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist

[An overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist]

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。

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。Microwave Ablation Device is a new product that has not been on any market around the world.

对于现有器械:

• 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(即风险分析、标签、临床评估报告、验证/验证数据等)说明这些变更。

• 提供证据(例如，BSI以前评审的参考编号)以证明BSI已被通知所有重大变更(如果适用)。

对于MDR下的初次申请，请确认该器械以前是否以MDD上市，以及与MDD认证的器械相比是否有任何变化

市场历史应包括欧盟和其他地区的批准。

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

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