The purpose of this guideline is to help and guide the registration applicant to prepare the registration declaration of single-use abdominal puncture device in order to meet the basic requirements of technical review. At the same time, it helps the review organization to conduct a scientific and standardized review of such products and improve the quality and efficiency of the review work.

This guideline is the general requirements for the registration of single-use abdominal puncture device, the registration applicant should be based on the characteristics of the specific product registration information to enrich and refine the content of the declaration. The applicant should also be based on the characteristics of the specific product to determine whether the specific content is applicable, and if not applicable, need to specify the reasons and the corresponding scientific basis.

This guideline is a guiding document for registration applicants and reviewers, but does not include the administrative matters involved in the registration and approval, and not as a mandatory implementation of regulations, should be used under the premise of complying with the relevant laws and regulations of this guideline. If there are other methods that can meet the requirements of the relevant regulations, they can also be used, but they need to provide detailed research information and validation information.

This guideline is formulated under the current regulations and standards and the current level of knowledge, with the continuous improvement of regulations and standards, as well as the continuous development of science and technology, the contents of this guideline will be adjusted in due course.

I. Scope of application

This guideline applies to single-use abdominal puncture device (hereinafter referred to as the puncture device), the product is used in laparoscopic surgery to puncture the human abdominal wall tissue, to provide access for the operation of surgical instruments.

Reusable abdominal puncture device, thoracic puncture device, etc., can refer to its applicable part of the content.

Second, the registration review points

(I) Regulatory information

1. Application form

1.1 Confirm the category and classification code of the product, according to the “Medical Device Classification Catalog” puncture device management category for Class II medical devices, classification code 02-12-01.

1.2 Focus on the Chinese name of the product, its naming should be in accordance with the “Naming Rules for Common Names of Medical Devices” and “Guidelines for the Naming of Common Names of Passive Surgical Devices” and other relevant guidelines for the naming of medical devices.

The original name of the imported puncture device should be consistent with the corresponding content in the marketing and sales certification document and the instruction manual of the country of origin.

Product List
2.1 Imported puncture device model specifications, structural composition should be consistent with the country of origin marketing documents and the corresponding content of the country of origin manual.

2.2 Concerned about whether the specifications of each model belongs to the same registration unit, such as different working principles of the puncture device, due to its different structural design, the performance requirements of the product indicators are different, can not be placed in the same registration unit.

(ii) General information

1. Working principle and structure of the applicator

In order to ensure airtightness during use, there exist 2 types of design for common applicators, one is to rely on the seals and mechanical valves of the puncture cannula to maintain the pneumoperitoneum, the structure of which is shown in Figure 1 below, and the structure of the applicator shown in the figure is not the only type; and the other is to be used in conjunction with a specialized pneumoperitoneum system, which is designed to recirculate the tiny pressure nozzle inside the applicator in order to produce an airtight seal that is usually comparable to the intra-abdominal pressure of the patient. A pneumoperitoneum in which the pressure barrier remains stable.

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2. Overview

Product description should be comprehensive, detailed, at least should include the name of the declared product, structural components and illustrations, the raw materials of the components, model specifications and division of the basis, the principle of operation, sterilization methods, intended use, applicable parts, technical performance indicators and their basis for the development, as well as differentiated from other similar products, such as the characteristics of the content.

3. Model specifications

Description of the product model specifications and division basis, clear the difference between the model specifications, can be a list of different model specifications of the structural composition, dimensions, performance indicators to be described, you can also use the schematic representation. All the differences between the different models and specifications, such as the end of the piercing rod, gas injection valve, piercing sleeve, sheath cap, etc. should be listed in the comparison table.

4. Packaging instructions

Labeling information on sterile primary packaging, including primary packaging raw materials, packaging forms, packaging raw material supplier information, etc.

Scope of application and contraindications
5.1 Scope of application: specify the intended use of the site.

5.2 Contraindications: clearly state that the device is not applicable to the crowd or situation.

6 reference to similar products or predecessor products

Provide information on similar products (domestic and foreign marketed) or predecessor products (if any), describing the background and purpose of the research and development of the product for registration. For similar products, explain the reasons for choosing them as R&D references.

The applicant for registration shall list and compare the similarities and differences between the product and the listed similar or predecessor products (if any), and the items to be compared shall include the product name, working principle, raw materials, structural characteristics, performance index, scope of application, production process, sterilization method, expiration date, and the comparative information with similar products in the market in terms of technology, design and application.

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