Browse > Article
http://dx.doi.org/10.9718/JBER.2019.40.6.250

A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System  

Kim, You Rim (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
Yu, Woo Jin (Medical Device Research Center, Korea Testing Laboratory)
Park, Ho Joon (Technical Document Review Center, Korea Testing Laboratory)
Jang, Won Seuk (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
Publication Information
Journal of Biomedical Engineering Research / v.40, no.6, 2019 , pp. 250-259 More about this Journal
Abstract
Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.
Keywords
Ophthalmic laser; Safety and performance; Clinical effectiveness; Evaluation;
Citations & Related Records
Times Cited By KSCI : 2  (Citation Analysis)
연도 인용수 순위
1 Kim CY, et al. Prevalence and characteristics of glaucoma among Korean adults. Korean J Ophthalmol. 2011;25(2):110-5.   DOI
2 Jung YH, et al. Glaucoma pathogenesis and lifestyle modification. J Korean Med Assoc. 2017;60(12):978-982.   DOI
3 Kim CY, et al. Treatment patterns and medication adherence of patients with glaucoma in South Korea. Br J Ophthalmol. 2017;101:801-7.   DOI
4 Asia-pacific Glucoma Society. Asia Pacific Glaucoma Guidelines 3rd ed. Amsterdam: Kugler Publications; 2016. pp. 1-156.
5 Paolo Lanzetta, et al. Immediate intraocular pressure response to selective laser trabeculoplasty. Br J Ophthalmol. 1999;83:29-32.   DOI
6 Seong MCl, et al. The Effectiveness of Selective Laser Trabeculoplasty in Steroid-Induced Ocular Hypertension. J Korean Ophthalmol Soc. 2011;52(7):876-880.   DOI
7 Lim KM, Song TJ. A Study on Classification and Differential Grade Management for Medical Devices. J Biomed Eng Res. 2018;39(6):268-77.   DOI
8 Kim JY, Noh SC, Choi HH, et al. A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device. J Biomed Eng Res. 2015;36(5):162-8.   DOI
9 Regulation on Medical Device Groups and Class by Group, Ministry of Food and Drug Safety Public Notification No. 2017-6.
10 FDA, Code of Federal Regulation 21, Part 886 Ophthalmic devices, 8886.4390 Ophthalmic laser.
11 Global Medical Device Nomenclature Database, GMDN Agency. Accessed on 20 Aug 2019.
12 Pmda, English edition of Japanese Medical Device Nomenclature (JMDN). As of Sep, 2018.
13 https://emed.mfds.go.kr/#!CECAB01F010. Accessed on 19 July 2019.
14 Common Standards and Specifications on Electromechanical Safety of Medical Devices, Ministry of Food & Drug Safety Public Notification No. 2015-115.
15 Common Standards and Specifications on Electromagnetic Safety of Medical Devices, Ministry of Food & Drug Safety Public Notification No. 2017-45.
16 Common Standards and Specifications on Biological Safety of Medical Devices Ministry of Food & Drug Safety Public Notification No. 2019-4.
17 Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research 2nd ed. Boca Raton, Florida: Chapman & Hall/CRC;2008. pp. 1-449.
18 https://clinicaltrials.gov/. Accessed on 20 Aug 2019.
19 Park JJ, Shao J, Lee JW, Lee KW. Comparison of Clinical Outcomes of Argon Laser Versus Selective Laser Trabeculoplasty in POAG. J Korean Ophthalmol Soc. 2008;49(9):1491-500.   DOI