(63 days)
The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are intended 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 intended for use in cardiac procedures.
NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations:
- Pregnant patients potential risks to patient and/or fetus have not been established .
- Patients with implantable pacemakers or other electronic implants. Implanted . electronic devices may be adversely affected by microwave power
- . Use on the central nervous system
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. The maximum selectable power for the system is dependent on the probe type used. For Certus", Certus " and Certus " probes, the maximum power is 140W when one probe is connected, 95Wper probe when 2 probes are connected and 65W per probe when 3 probes are connected. When Certus® probes are used, the maximum power is 65W regardless of the number of probes connected. An intermediate iunction 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.
The ablation probe assembly contains 4 main sections: a handle, a cannula, a radiating section and a faceted tip for insertion. The probes have a triaxial antenna design is created from a coaxial monopole antenna passed through a hollow needle. The needle creates the triaxial structure and its tip is positioned approximately ¼ of a wavelength proximal to the monopole base. This positioning improves antenna efficiency and reduces fields flowing back on the coaxial outer conductor. In turn, more energy is deposited in the tissue.
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 text describes a 510(k) summary for the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories. However, it does not contain the specific details about "acceptance criteria" and "device performance" in the format of a clinical study with statistical outcomes.
The "Performance Data" section mentions that the device "has been verified through rigorous testing that, in part, supports the compliance of Certus 140 2.45 GHz Ablation System and Accessories to the standards listed above." It then immediately states, "Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device."
This indicates that some performance testing was done, but the document does not provide any quantitative acceptance criteria, reported device performance metrics, sample sizes (for test or training sets), ground truth establishment details, or information about expert involvement (number, qualifications, adjudication) associated with these studies. It also does not mention any multi-reader multi-case (MRMC) studies or standalone algorithm performance.
Therefore,Based on the provided text, I cannot complete the table or answer most of your questions as the requested information is not present. The document focuses on regulatory compliance, device description, and intended use rather than detailed clinical study results and acceptance criteria.
§ 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.