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The WavelinQ™ Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The WavelinQ™ Generator is a high frequency isolated generator that utilizes electrical current to deliver radiofrequency (RF) energy to the catheter electrode for formation of a vascular fistula. The generator offers a receptacle for a monopolar handpiece. The WavelinQ™ Generator is intended to be used with the currently marketed and cleared device WavelinQ™ EndoAVF System (K192239). The generator has one setting (AV1) equivalent to the mode (Cut T, 60W, 0.7s) of the predicate device, ESU-1 Electrosurgical Generator, that is used during the WavelinQ™ EndoAVF System procedure. This mode is set to deliver energy at 60 Watts for 0.7 seconds. The generator has a return electrode contact, for use with a split ground pad, and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use only a split return electrode, also referred to as a split ground pad.

The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).

The provided text is a 510(k) Summary for a medical device (WavelinQ™ Generator) and does not contain information about an AI/ML-based device. Therefore, it is not possible to describe acceptance criteria, a study proving device performance, or details regarding AI/ML ground truth, expert opinions, or MRMC studies, as none of that information is applicable to this document.

The document discusses the substantial equivalence of the WavelinQ™ Generator to a predicate device based on its intended use, indications for use, technological characteristics, and performance testing for electrical safety, mechanical aspects, reliability, and functionality. The tests performed are standard for electro-surgical devices and do not involve AI/ML components or human interpretation of outputs that would require multi-reader studies or complex ground truth establishment for AI model evaluation.

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