(8 days)
Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue.
The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-party electrosurgical generators. Coagulation occurs between two stationary insulated electrodes which are continuously drip irrigated during use. Second, the TRIOwand provides user controlled delivery of aspiration/vacuum for the evacuation of fluids from the surgical site. Third, the TRIOwand provides the user the ability to deliver irrigation for flushing the surgical field.
This submission covers a single configuration of the device:
- . NICO TRIOwand - 4mm diameter, 14cm length, pre-bent (~30°)
The direct patient contacting materials consist of PEBAX® and stainless steel. The indirect contacting materials are Tygon®, polycarbonate, ABS, PC/ABS, silicone, and Dymax glue.
This document describes the NICO TRIOwand, an electrosurgical device. The information provided heavily focuses on regulatory aspects, comparisons to predicate devices, and a list of nonclinical tests performed. It does not contain the specific acceptance criteria or detailed results of a study that prove the device meets these criteria in the format requested.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert involvement, or ground truth as this information is not present in the provided text.
The document states that "The following tests were performed and demonstrate that the subject device met applicable design and performance requirements, and supports a determination of substantial equivalence." However, it only lists the types of tests, not the detailed acceptance criteria for each test or the specific results that satisfied those criteria.
For example, it lists "Ex-Vivo Animal Study for Comparison to Predicates" but does not provide details on the study design, sample size, or results. Similarly, "Design Validation/Simulated Use" is mentioned, but without any specifics on the validation metrics or outcomes.
In summary, the provided text lacks the detailed scientific study results and acceptance criteria breakdown necessary to complete the requested table and answer many of the specific questions.
§ 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.