Authors: Yasir A. Al-Dojaily BMSc ., Nawar A. Alkhamesi MD, PhD, FRCS (Gen. Surg.), FRCS, FRCSEd., FRCSC, FACS, FASCRS
Scivita Medical Technology Co. Ltd. (Suzhou, China) received FDA approval for their 4K Ultra High-Definition (UHD) Laparoscope on February 24th, 2021.
The 4K UHD Laparoscope is a rigid, high-resolution endoscope. In principle, the use of 4K ultra high-definition endoscopy provides detailed surgical views and potentially reduces operative time and complications1,2. The endoscope is available in 12 models ranging in length (290 – 330 mm) and view direction (0o – 45o) that insert into 5.5 mm or 10 mm ports. There device contains a Scivita-manufactured 4K UHD camera system for operative site visualization. The device is compatible with LED and xenon light sources.
The Laparoscope was shown to be safe, effective, and biocompatible in nonclinical testing. The FDA determined that the 4K UHD Laparoscope was substantially equivalent to the predicate device, “ULTRA” Telescopes, manufactured by Olympus Winter & Ibe GmbH (Hamburg, Germany).
The 4K UHD Laparoscope is FDA-approved for endoscopy and endoscopic surgeries within the thoracic and peritoneal cavities as well as for transanal and transvaginal endoscopy.
The endoscope is contraindicated if there is an absolute contraindication to endoscopy or endoscopic surgery. The 4K UHD Laparoscope is reusable by cleaning and steam sterilization between each new use.
References:
- Ahn J hyuk, Kim JH, Yi JW, Hur MH. Comparison between the 4K ultra-high definition (UHD) and high definition (HD) endoscopic systems for transoral endoscopic thyroidectomy. Gland Surg. 2020;9(2):229-237. doi:10.21037/gs.2020.01.06
- Rigante M, La Rocca G, Lauretti L, et al. Preliminary experience with 4K ultra-high definition endoscope: analysis of pros and cons in skull base surgery. Acta Otorhinolaryngol Ital. 2017;37(3):237-241. doi:10.14639/0392-100X-1684