Tingsheng Medical's Disposable Intracardiac Echocardiography Diagnostic Catheter (Registration No. CQZ2300664) Receives NMPA Approval

Feb 29, 2024 09:56 CST Updated 09:56

TINGSN

Developer of Cardiac Interventional Treatment Devices

Source of the article: National Medical Products Administration；Editor:Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

November 29, 2023Jiangsu TINGSN Technology Co., Ltd.Developed bySingle-Use Intracardiac Ultrasound Diagnostic Catheter`, approved for NMPA Class III registration certificate`。

This product is composed of a catheter body, an operating handle, and a connector. When used with the company's portable color ultrasound diagnostic equipment, it is suitable for medical institutions.Perform ultrasound imaging of the heart, major cardiac vessels, and intracardiac anatomical structures.. This product uses high-frequency ultrasound for two-dimensional imaging and three-dimensional modeling of the heart area, enabling accurate, rapid, and efficient ultrasound surgery.

Product launch helps reduce clinical treatment costs, benefiting more patients.。

Application No.: CQZ2300664

Technical Review Report for Medical Device Product Registration

Product Name in Chinese: Single-use Intracardiac Ultrasound Diagnostic Catheter

Product Management Category: Class III

Applicant Name：Jiangsu TINGSN Technology Co.,Ltd.

National Medical Products Administration

Center for Medical Device Evaluation

Basic Information

1. Applicant Name

Jiangsu TINGSN Technology Co., Ltd.

2. Applicant's Address

21st Floor, Building B, Phase I, Sino-Danish Eco-Life Science Industrial Park, No. 3-1 Xinjinhuhu Road, Jiangbei New District, Nanjing, China

3. Production Address

21st Floor, Building B, Phase I, Sino-Danish Eco-Life Science Industrial Park, No. 3-1, Xinjinhu Road, Jiangbei New District, Nanjing, China

Technical Review Overview

1. Product Overview

(1) Product Structure and Composition

The product consists of a catheter body, an operating handle, and a connector.

(2) Product Applicability Scope

This product is used in medical institutions, together with the portable color ultrasound diagnostic instrument (Model: TINGSN FINDERS 1, Software Release Version: 1) produced by our company, and is suitable for ultrasonic imaging of the heart, major cardiac vessels, and intracardiac anatomical structures.

(III) Model/Specification

TINGSN Sonic Eyes 10

(IV) Working Principle

This product is an imaging catheter used for intracardiac ultrasound imaging. After establishing a channel through femoral vein puncture, it is delivered to the heart area via blood vessels and used in conjunction with the ultrasound diagnostic system produced by our company. The transducer emits mechanical ultrasonic waves, which propagate through the medium and generate echoes at places where density changes. These echoes are then processed by a computer to provide real-time, high-resolution image information. The ultrasound imaging component uses a phased array transducer, with piezoelectric ceramic as the array element material, encapsulated inside the distal tip of the catheter. In addition to the ultrasound transducer, a temperature sensor is installed at the distal tip of the catheter to monitor the internal temperature of the catheter tip.

2. Overview of Preclinical Studies

(1) Product Performance Research

The applicant provided research materials on product performance and a compilation explanation of product technical requirements, offering the basis for determining functional and safety indicators such as ultrasound performance, operating modes, image functions, appearance, dimensions, mechanical performance, chemical performance, sterility, endotoxins, electrical safety, and electromagnetic compatibility. The indicators in the product technical requirements refer to relevant national and industry standards, including: GB 10152-2009, YY0285.1-2017, YY 0676-2009, YY/T 1659-2019, GB/T 19335-2022, etc.

(II) Biocompatibility

The applicant evaluated the biocompatibility of the catheter portion of the finished product that directly contacts the patient according to GB/T 16886.1-2011. The evaluated material has short-term contact with the human circulatory blood path, and biological tests were conducted (including: cytotoxicity, skin sensitization, intradermal reaction, pyrogen, hemolysis, coagulation, thrombosis, acute systemic toxicity), and a biological test report issued by a medical device testing institution was submitted.

(III) Sterilization

The product is sterilized with ethylene oxide by a third party commissioned by the manufacturer, with a sterility assurance level of 10^-6. The applicant conducted sterilization validation using the half-cycle method in accordance with the ISO11135 standard and submitted a sterilization validation report. Residuals were removed through natural outgassing, and test reports for EO and ECH residual levels were submitted.

(IV) Product Validity Period and Packaging

The product is for single use and claimed to have a shelf life of 2 years. The applicant conducted validation of the shelf life using accelerated aging methods, selecting samples that underwent double sterilization and were aged under specific temperature and humidity conditions. Samples were taken at different equivalent time points for performance testing, including tests on packaging, appearance, physical properties, temperature measurement, ultrasound performance, chemical properties, sterility, and endotoxins. All results met the requirements. The applicant also provided relevant verification data for packaging seals, packaging integrity, and transportation tests.

(5) Animal Studies

The applicant provided animal experimental data comparing the declared product with similar imported products already on the market. The declared product and the control product were respectively paired with their claimed ultrasound diagnostic instruments, and a pig model was selected for the trial. The experimental group catheter and the control group catheter were delivered to the animal’s heart chambers via the femoral vein approach. Images from different locations were collected to evaluate the imaging quality of the two groups of products, the performance of the catheters, and the performance of the main units. Safety evaluations were conducted through blood tests and gross anatomy.

The results showed that there was no statistically significant difference between the experimental group and the control group. The performance of the catheters, the safety and stability of the main unit showed no abnormalities in both groups. There was no significant thrombosis observed in the animals, no adverse reactions occurred, and histopathological examination revealed no obvious necrosis, infarction, or bleeding.

(6) Others

The applicant has conducted a study on the acoustic energy safety of the product, clarified the acoustic energy limits by referring to internationally recognized relevant guidelines, carried out acoustic energy output tests in accordance with relevant standards, and provided test data. The results meet the limit requirements.

(7) Safety Indicators for Active Devices

The product complies with the relevant general requirements of GB 9706.1-2007 and the specific safety requirements of GB 9706.9-2008, as well as the electromagnetic compatibility collateral safety requirements of YY 0505-2012, and provides a test report issued by a medical device inspection agency for use in conjunction with the company's ultrasound diagnostic system.

3. Overview of Clinical Evaluation

This application conducts clinical evaluation through the comparison pathway of the same type of product, selecting an imported, similar product that is already on the market as the comparison device. The declared product is identical to the comparator in basic principles, structural composition, and intended use, but differs in manufacturing materials, performance parameters, and other aspects. To address these differences, evidence such as acoustic phantom imaging effect tests, delivery and withdrawal tests based on anatomical phantoms, and animal experiments were submitted to demonstrate the safety and effectiveness of the declared product. Additionally, clinical trial data of the declared product was provided as supplementary supporting evidence.

Among them, the animal experiment used healthy pigs as the research subjects, with products of the same type serving as the control group. The experimental and control groups conducted imaging evaluations on various parts of the animals' hearts, obtaining ultrasound images for quality assessment, which showed that the excellent imaging rate was consistent with products of the same type. Additionally, the stability and operability of the product application were evaluated, along with blood routine, blood biochemistry, coagulation function at different postoperative times, and gross anatomical observations, showing consistent results between the groups.

The clinical trial was a feasibility study that performed imaging observation of the heart chambers and some anatomical structures within the heart in enrolled subjects. The excellent imaging rate was 100%, and no device-related adverse events occurred during follow-up until 2 days post-operation.From the perspectives of operational difficulty via catheter access, tissue acoustic imaging characteristics, anatomical structures and shape similarities, and the ultrasound modes used, it can be considered that the observation sites in animal experiments and clinical trials are representative of the clinical imaging effects of various anatomical structures within the heart.

4. Product Benefit-Risk Determination

Product Benefits:

This product is used in conjunction with the ultrasound diagnostic equipment produced by our company, and is suitable for ultrasonic imaging of the heart, major cardiac blood vessels, and intracardiac anatomical structures, providing doctors with an additional imaging observation and diagnostic method during interventional cardiac procedures.

Product Risk：

1. The risk of inaccurate observation and judgment due to poor imaging quality caused by operation;

2. Improper operation may lead to the risk of injury or even perforation of intracardiac and vascular tissues. The above risks can be effectively controlled through adequate training of users before clinical use, warnings and notices in the instruction manual, etc. Based on the application materials provided by the applicant, after comprehensive evaluation, it is considered that the benefits brought by the product to the applicable population outweigh the risks at the current level of understanding.

Comprehensive Evaluation Opinion

This product belongs to innovative medical devices (Innovation Review Acceptance Number: CQTS2200294).。According to the Regulations on the Supervision and Administration of Medical Devices (Decree No. 739 of the State Council), the Measures for the Administration of Medical Device Registration and Filing (Decree No. 47 of the State Administration for Market Regulation), and other relevant medical device regulations and supporting rules, after a systematic evaluation of the registration application materials submitted by the applicant, the declared product meets the requirements for safety and effectiveness and is in line with the current level of understanding. It is recommended to grant registration.

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