(819 days)
The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery--laparoscopic, endoscopic, and open.
The 'TC' is a microprocessor controlled Helium Thermal Coagulator. Working at 2 to 33 watts of power with Helium gas flows of 1 to 5 liters/minute depending on procedure and probe. The 'TC' automatically works with all of the flexible disposable probes. Models T, C, D, E, R, and S. (Size range 2.5mm to 4mm x 60 mm to 310mm)
Please provide the full text of the study or report that proves the device meets the acceptance criteria. The provided document is a 510(k) summary for the Helica TC (Thermal Coagulator) and a clearance letter from the FDA, which describes the device and its intended use, and states that it has been found substantially equivalent to predicate devices. However, it does not contain the detailed study information needed to fill out all aspects of your request (e.g., specific acceptance criteria, study design, sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance data).
The provided text only includes a comparison of the Helica TC with predicate devices regarding safety and performance, mentioning "Published studies show that gas-enhanced electrosurgery is safe effective" but not providing details about these studies or how they specifically relate to the Helica TC's acceptance criteria. It also lists compliance with electrical standards (IEC 601-1, IEC 601-2-2, ANSI/AAMI HF18) as a performance metric.
Therefore, without the actual study report, I cannot provide a complete answer to your request. If you can provide the study report, I would be happy to analyze it and extract the requested information.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.