Author(s)

Sheng Zhao¹, FuCheng Wang², Tao Hu^2*, Dan Wu², JieBing Ma², BaoLi Zhang²

Affiliation(s)

¹Ultrasound Diagnosis Department, Maternal and Child Health Hospital of Hubei Province, Wuhan 430070, Hubei, China.

²Wuhan Zoncare Bio-medical Electronics Co., Ltd., Wuhan 430070, Hubei, China.

Corresponding Author

Tao Hu

ABSTRACT

Background: Post-market clinical follow-up (PMCF) studies are essential for verifying the real-world safety and performance of medical devices. This study evaluated the ViV 80 Color Doppler Ultrasound System (Zoncare) against the Model R**7 from a well-established manufacturer (M** company) in routine clinical practice. Methods: A prospective, observational, single-center study was conducted at Maternal and Child Health Hospital of Hubei Province, China. A total of 363 cases (140 male, 223 female) underwent abdominal, thyroid, cardiac, and gynecologic examinations using four probe types (convex, linear, phased array, volume). Endpoints included image consistency (target ≥95%), positive detection rate, and adverse events. Results: Image Consistency: All probes met the 95% target (convex: 97%; linear: 100%; phased array: 95%; volume: 96%). Moreover, mean image quality scores were consistently high, with the ViV 80 performing comparably or superiorly to the R**7 in each body site; Detection Rates: Varied by anatomy (liver: 44%; thyroid: 31%; cardiac: 8%; uterus: 26%), reflecting clinical heterogeneity; Adverse Events: No device-related adverse events occurred; five cases reported transient pressure sensations (1.4%). Conclusion: The ViV 80 demonstrated non-inferiority to the R** 7 in image quality and safety, supporting its continued use in diverse clinical applications.

KEYWORDS

Color Doppler Ultrasound System; Post-market clinical follow-up; Safety; Performance; Image consistency; MDR; PMCF; ViV 80

CITE THIS PAPER

Sheng Zhao, FuCheng Wang, Tao Hu, Dan Wu, JieBing Ma, BaoLi Zhang. Post-market clinical follow-up study of the Color Doppler Ultrasound System: a prospective, comparative evaluation of safety and performance. Journal of Pharmaceutical and Medical Research. 2025, 7(2): 37-43. DOI: https://doi.org/10.61784/jpmr3044.

REFERENCES

[1] European Parliament and the Council. Regulation (EU) 2017/745 on medical devices. Official Journal of the European Union. 2017. http://data.europa.eu/eli/reg/2017/745/oj.

[2] European Commission. MEDDEV 2.7/1 revision 4: Guidelines on medical devices. European Commission Document. 2016. https://health.ec.europa.eu/document/download/e11b73e3-a7e0-4c2b-a950-c46e155871e2_en.

[3] ISO. Clinical investigation of medical devices for human subjects – Good clinical practice. ISO Standard 14155. 2020. https://www.iso.org/standard/71690.html.

[4] NMPA. [Guidelines for clinical trial design of medical devices]. National Medical Products Administration. 2018. https://www.nmpa.gov.cn/directory/web/nmpa/images/MjAxOMTqtdo2usXNqLjmuL28i5kb2M=.doc.

[5] NMPA. [Technical review guidelines for ultrasound diagnostic equipment (Class III)]. National Medical Products Administration. 2015. https://www.nmpa.gov.cn/directory/web/nmpa/images/1610962597329082242.doc.

[6] Pearson K. Note on regression and inheritance in the case of two parents. Proceedings of the Royal Society of London. 1895, 58: 240-242.

[7] Hair JF, Black WC, Babin BJ, et al. Multivariate data analysis (8th ed.). Boston: Cengage Learning, 2019.

[8] Altman DG. Practical statistics for medical research. London: Chapman & Hall, 1991.

[9] QuickStats: Percentage of adults aged ≥18 years with diagnosed heart disease, by urbanization level and age group – National Health Interview Survey, United States, 2020. MMWR Morb Mortal Wkly Rep. 2022, 71(23): 778. DOI: 10.15585/mmwr.mm7123a4.

[10] Mathiesen UL, Franzén LE, Aselius H, et al. Increased liver echogenicity at ultrasound examination reflects degree of steatosis but not of fibrosis in asymptomatic patients with mild/moderate abnormalities of liver transaminases. Digestive and Liver Disease. 2002, 34(7): 516-522. DOI: 10.1016/S1590-8658(02)80111-6.

[11] Wu MH, Chen CN, Chen KY, et al. Quantitative analysis of echogenicity for patients with thyroid nodules. Scientific Reports. 2016, 6: 35632. DOI: 10.1038/srep35632.

[12] Caminiti G, Volterrani M, Iellamo F, et al. Acute changes in myocardial work during isometric exercise in hypertensive patients with ischemic heart disease: A case–control study. Journal of Clinical Medicine. 2024, 13(19): 5955. DOI: 10.3390/jcm13195955.

[13] Wen Z, Zhuang H. Value of acute ultrasonography in diagnosing right hypogastric acute abdomen. West China Medical Journal. 2010, 25(12): 2214-2217.

[14] Ma’aji M, Jiya NMA, Saidu A, et al. Transabdominal ultrasonographic findings in children with sickle cell anemia in Sokoto, North-Western Nigeria. Nigerian Journal of Basic and Clinical Sciences. 2012, 9(1): 14-17.