(178 days)
The HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings.
The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.
The HEATfx Microwave Ablation System is a mobile system intended to deliver microwave energy for thermal tissue ablation using a minimally invasive procedure. The HEATfx Microwave Ablation System is comprised of a console with optional cart, microwave ablation needles with cooling water manifold, optional thermal sensor, and related accessories.
The HEATfx console is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The HEATfx System utilizes three 2450 MHz, 145W generators to deliver microwave energy to up to three HEATfx Needles.
The HEATfx Microwave Ablation Needles are inserted into the target lesion under ultrasound or CT image guidance during laparoscopic procedures, or using direct visualization during surgical procedures, and operated using the console. The needles incorporate an antenna that transmits the microwave energy uniformly around the needle shaft. When connected to the HEATfx console, the console's internal pump and a disposable water manifold circulate sterile water through the needle for needle cooling and facilitating a uniform ablation zone.
The optional Multi-Point Thermal Sensor allows the user to monitor tissue temperatures near critical structures during an ablation procedure.
The system must be used with an irrigation baq of sterile water (not provided with the system).
The provided text describes the HEATfx Microwave Ablation System's 510(k) submission to the FDA. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/machine learning device.
The document focuses on the substantial equivalence of the HEATfx Microwave Ablation System to a predicate device (Emprint Ablation System) based on technological characteristics, performance data (system, mechanical, electrical, software, needle, thermal sensor, ex-vivo, in-vivo, biocompatibility, usability, packaging, sterility, pyrogenicity testing), and intended use.
Therefore, for the specific questions related to AI/ML device acceptance criteria and studies (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance), the provided text does not contain the necessary 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.