Ligation clip (closed clip) registration case analysis

1. Product Overview of Disposable Ligation Clip

Disposable ligation clips are also called closed clips. They are often injection molded from polymer materials (such as POM). They are placed on a base with a cover, wrapped in a PET blister box and dialysis paper, and then sterilized by ethylene oxide. Whether the material is degradable is divided into non-absorbable and absorbable ligature clips, which are used for one time. It is mainly used to clamp blood vessels to stop bleeding or close tubular tissues in surgical operations, including small and medium arteries and veins, bile ducts, etc. It is not suitable for large arteries and large veins.

2. Information on the main manufacturers of disposable ligature clips

Imported products are mainly Hem-o-lok ligature clips from Teleflex Medical Co., Ltd. and Click’aV ligature clips from GRINA in the UK. Domestic product suppliers are mainly in Jiangsu and Zhejiang, such as Kangji, Pricestar, and Zhouji.

3. Classification information of ligature clips

Code

Subdirectory

Primary product category

Secondary product category

Product Description

expected usage

Example of product name

category

02

06

Surgical instruments-clip

01 closing clip

It is usually U-shaped with a buckle. It is generally made of chemical synthesis or polymer materials. Provided aseptically. One-time use.

It is used to close the tubular tissue structure and is not removed after surgery.

Absorbable hemostatic ligation clip, non-absorbable polymer ligation clip


4. Division of ligature clamp registration unit

 The registration unit is divided in accordance with the guidelines for the division of passive medical device registration units. For example, different material polymerization methods need to be divided into different registration units: homopolyoxymethylene and copolyoxymethylene.

5. Requirements for clinical evaluation of ligation clips

Ligation clip products have been included in the list of medical devices exempted from clinical trials, and registration can be made by submitting clinical evaluation materials that are exempt from clinical trials. The exempt clinical catalog is described as follows:

Classification

Code

product name

Product Description

Management category

02-06-01

closing clip

Used to mark, stop bleeding or close tubular tissue structures. Can be equipped with a conveyor. The product is equivalent to the product that has been approved for domestic registration, and the product composition materials are mature. Except for absorbable materials, new structural design, new mechanism of action, and combination products of medicine and equipment.

6. Main technical requirements of ligation clamp

1 size

2 Appearance

2.1 The shape of the ligation clip is complete, and the hand feels flat. Except for the inner anti-skid teeth, the rest should be free of burrs, flashes, cracks, and spots.

2.2 There should be non-slip teeth on the inside of the ligation clip. The non-slip teeth should be complete, clear, and evenly arranged without defects such as overflow angles and sharp edges.

3 Toughness: The ligation clamp should have good toughness, and there will be no cracks and fractures after being clamped.

4 Clamping performance

5 Assembly performance: The assembly of the ligation clip in the base should be firm and not fall off.

6 Anti-expansion performance: The ligature clip should be able to withstand the tension of: large clip 10N; medium clip 10N; small clip 5N without detaching.

7 Fatigue resistance: After the ligation clip is clamped, there should be no lock disengagement, breakage, etc. after being subjected to the pressure in the 50KPa pipe for 48 hours.

8 Sterility: The ligation clip should be sterile after sterilization.

9 Bacterial endotoxin: Bacterial endotoxin should not be greater than 10EU/unit.

10 Residual amount of ethylene oxide: After the ligation clip is sterilized by ethylene oxide, the residual amount of ethylene oxide should be ≤10μg/g.

11 Chemical properties: The dissolving product of the polymer material in contact with the patient should meet the following requirements:

11.1 Extractable heavy metal content: The heavy metal content of the ligation clip leaching solution should not exceed 5mg/L, and the content of cadmium should not exceed 0.1mg/L.

11.2 pH: The ligation clip extract is compared with the blank control solution of the same batch, and the difference in pH shall not exceed 1.0.

11.3 Easily oxidized: the ligation clip leaching solution is compared with the blank control solution of the same batch, and the difference in consumption of 0.002mol/L potassium permanganate solution shall not exceed 0.5ml.

11.4 Evaporation residue: The total amount of dry residue of the dissolution liquid should be ≤2.0mg.

11.5 Ultraviolet absorbance: The absorbance of the ligation clip leaching solution in the wavelength range of 250nm ~ 360nm should not be greater than 0.1.

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