(147 days)
The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings.
The Certus 140™ 2.45 GHz Ablation System is not indicated for use in cardiac procedures.
The system is designed for facility use and should only be used under the orders of a clinician.
The system has a single 2.45 GHz signal source generator and three (3) independent power amplifiers, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. Up to 3 microwave ablation probes can be connected to and powered by the system at one time. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.
Probes are provided sterile and are intended for single patient use only. Ablation probes are comprised of a sharp trocar on the end of a cannula, a probe handle, a 1.4 meter cable and a connector assembly.
Models Certus", Certus", and Certus" have 17 gauge cannula and are available in 15 cm and 20 cm lengths.
Model Certus®, has a 13 gauge cannula and is available in a 25 cm length only.
Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.
Additionally, different ablation probes have been designed to optimize the energy transfer efficiency from the probe into different types of tissue based on known electrical properties of each tissue.
Certus " probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus " probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in lung tissue.
The antenna of the Certus® probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. Certus " Probes were developed to provide physicians with an additional ablation probe designed specifically for ablating smaller lesions. The Certus® probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation. Certus " probes will enable physicians to ablate smaller lesions while limiting necrosis of adjacent tissue when compared to other Certus probes.
A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy. This function is similar in use to the stick function available on cryogenic ablation systems.
The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.
The provided 510(k) summary for the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories does not describe a study involving an AI/Machine Learning algorithm.
Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.
The summary describes a medical device for soft tissue ablation and its modifications, focusing on substantial equivalence to predicate devices and compliance with international standards. The performance data mentioned refers to ex-vivo studies conducted to compare the new device with a predicate device, which would typically involve physical measurements of ablation zones rather than AI-driven evaluations.
§ 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.