Authors: Christina Cuoccio, MD; Luca Milone, MD, FACS
Micro-Tech (Nanjing) Co., Ltd. received FDA approval for the Single Use Electrosurgical Knife on July 24th, 2020.
Since the device is substantially equivalent to legally marketed devices that were previously marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act that do not require approval of a premarket approval application.
The electrosurgical knife is designed to be used in conjunction with endoscopes and electrosurgical units (ESU) for dissection, elevation, irrigation, and preparation of tissue layers in combination with monopolar cutting and coagulation within the within the alimentary tract. The device has 3 electrosurgical tips available: the I-type (versatile application), T-type (marking/dissection, less likely to slip), and O-type (spherical tip to maximize coagulation effect).
The Single Use Electrosurgical Knife consists of a cutting Knife, the outer tube assembly, the middle Tube assembly and the handle assembly. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the working channel of an endoscope with a required diameter of at least 2.8mm. To activate cautery, the Cutting Knife is extended out and the ESU’s footswitch is engaged.
Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that it works as intended with the compatible devices. The results of the tests were evaluated as substantially equivalent to the predicate device, Single Use Electrosurgical Knife (K171158). The bench testing performed demonstrated that the proposed device and predicate device are substantially equivalent.
FDA has determined this device to be substantially equivalent to Single Use Electrosurgical Knife (K171158), Olympus Medical Systems Corporation.
The Single Use Electrosurgical Knife has been designed to be used with endoscopes and electrosurgical units for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.
Currently, there are no reported contraindications for this device.
