Tianjin Medical Device Evaluation and Inspection Center Releases Technical Review Report for Fat Collector

Registration Form

þRegistration

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□ Renewal Registration

Product Name

Fat Collector

Applicant

Just Medical (Tianjin) Co., Ltd.

Production Address

No. 24, Keda Road, TEDA (Jinnan) Microelectronics Industrial Park, Jinnan District, Tianjin, China

Technical Review Content

1. Product Overview

Product Name: Fat Collector

Classification Code：02-15

Model、Specification：FC-30

Structure and Composition：The product consists of a suction part, a handle part, and an adapter. It is sterilized and packaged for single use.

Scope of Application: The product is used for the collection and filtration of autologous adipose tissue.

2. Similar Products and Previous Registration Status of This Product

The "Fat Collector" applied for registration this time is in the same category as the "Liposuction Tube" produced by Shanghai Zhonghe Tiangong Co., Ltd. and the Autologous Fat Microfragment Extraction Device produced by Qingdao Libaijian Biotechnology Co., Ltd. Registration certificate numbers of similar products: Hu Food and Drug Administration Medical Device (Approval) No. 2012-2010042, Registration Certificate No.: Lu Medical Device Approval No. 202220 21315.

3. Main Evaluation Content on Product Safety and Effectiveness

（1）Working Principle: The fat collector is connected to a negative pressure suction device to collect fat. During the fat collection process, the inside of the product is in a low vacuum negative pressure state. The negative pressure suction draws the fat tissue into the inner side of the filter screen in the handle. The fat tissue is intercepted by the filter screen (the pore size of the filter screen is between the diameter of fat tissue and residual blood and other impurities; small particle fat diameter >1.2mm, filter screen pore size approximately 180μm), retaining the fat within the inner side of the filter screen. Meanwhile, residual anesthetic infiltration fluid, blood, oil droplets, and other liquid impurities in the tissue flow through the filter screen to the negative pressure suction recovery device under the effect of negative pressure suction.

（2）The product's performance was evaluated based on the performance research data submitted by the applicant.

（3）According to the provisions of the GB/T 16886 series of standards, the biological characteristics of the product were evaluated.

（4）The product's shelf life and transportation stability were evaluated based on the stability study data submitted by the applicant in accordance with the YY/T 0681 series of standards.

（5）The relevant research materials on sterilization validation and confirmation submitted by the applicant were evaluated according to the GB 18279 series of standards.

（6）According to the "Technical Guiding Principles for Comparative Description of Products Included in the Directory of Medical Devices Exempt from Clinical Evaluation," the applicant's submitted data on other factors affecting the safety and effectiveness of the product have been evaluated.

4. Evidence provided by the enterprise

(1) Performance and Safety: Submitted the product commissioning inspection report issued by the Tianjin Medical Device Quality Supervision and Inspection Center of the National Medical Products Administration (Inspection Report No.: 2023-DJ-0001) and the product commissioning inspection report issued by the Hangzhou Medical Device Quality Supervision and Inspection Center of the National Medical Products Administration (Inspection Report No.: G2023 2877).

(2) Biological Characteristics Research Data: Biocompatibility Research Data.

(3) Stability study data: Shelf life (or usage stability) and transportation stability study data.

(4) Sterilization Validation Report

(5) Other materials affecting the safety and effectiveness of the product: Comparative data between the information of the declared product and the content described in the Catalog, as well as a comparison statement between the declared product and the medical devices already registered in China as listed in the Catalog. The comparative products include the "Liposuction Tube" produced by Shanghai Zhonghe Tiangong Co., Ltd., with the registration certificate number: Hu Food and Drug Administration Medical Device (Approval) Word 2012 No. 2010042; and the Autologous Fat Microfragment Extractor produced by Qingdao Libaijian Biotechnology Co., Ltd., with the registration certificate number: Lu Medical Device Registration Approval 20222021315.

5.Existing Problems and Main Corrective Opinions

(1) The structure and composition as well as the intended use of the product in this application are inconsistent with those in the classification notification. Please confirm whether the newly added component, the three-way valve, is a medical device and its category, and analyze whether the addition of the new intended use changes the product's management category.

(2) Please explain in detail how the working principle utilizes a filter screen to filter out residual blood, anesthetic infiltration fluid, etc., from adipose tissue, and which components achieve the concentration and purification of adipose tissue.

(3) Please combine the "transfer" function of the declared product, add corresponding performance index requirements, and supplement the inspection.

(4) Please provide a comparative analysis in list form between the declared product and the entrusted party's already registered "Disposable Arterial Blood Micro-Embolism Filter (Registration Certificate No.: China Medical Device Registration Approval 20193101981)" regarding differences in product structure; confirm whether the differences in product structure, primary packaging materials, sealing process, etc., will affect the sterilization effectiveness and residual gas resolution, and submit supplementary supporting documentation.

Material.

（5）Please further improve the biological evaluation data in accordance with GB/T16886.1-2022, and submit supplementary supporting data related to the biological risks of non-material-mediated pyrogenicity and acute systemic toxicity.

（6）Please confirm the product category of the three-way valve in the structural composition; Class II devices should not contain components of Class III products. There are differences in working principles, structural compositions, and intended uses between the approved domestic medical devices and the declared product. It is recommended to select a device that is substantially equivalent to the declared product to demonstrate the safety and effectiveness of the declared product's clinical use, and provide supporting documentation. If equivalence cannot be demonstrated, an appropriate clinical evaluation pathway should be chosen to submit clinical evaluation data.

6. Evidence or modifications provided by the company regarding "existing issues and main corrective opinions"

(1) The scope of application and product description have been re-standardized, and the product category has been reconfirmed with relevant basis submitted.

(2) The working principle of the product has been explained in detail according to the revised scope of application.

(3) The corresponding performance indicators have been added and supplementary inspections have been carried out.

(4) The sterilization validation data for the declared product has been resubmitted.

(5) The biological evaluation data has been re-perfected, and supplementary supporting data related to material-mediated pyrogenicity and acute systemic toxicity biological risks have been added.

(6) It has been confirmed that the declared product does not contain Class III device components. A new comparative product has been selected to demonstrate the safety and effectiveness of the product, and supporting materials have been submitted.

Comprehensive Opinion:

Options:þMeets the technical review requirements, and it is recommended to grant registration.

□ The application materials do not meet the technical review requirements, and it is recommended not to grant administrative permission.

□The applicant failed to submit supplementary materials within the prescribed time limit.，Termination of Technical Review，It is recommended not to grant administrative permission.

Chief Reviewer：Chen Yongxia    October 10, 2023

Review：Gou De ShuangOctober 10, 2023

Issue：Zhang Wenjie           October 1, 20231Day