(13 days)
The Model 1500 Electrosurgical RF Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.
The Model 1500 Electrosurgical RF Generator is designed to provide monopolar radiofrequency (RF) energy. The RF Generator is a 150 W electrosurgical generator specifically designed for use with RITA electrosurgical devices. It can read multiple temperature sensors and includes impedance and power monitoring to assist the physician in monitoring and controlling the ablation.
To use the system, the RF Generator is plugged into the wall outlet via the Power Cord. The electrosurgical device is connected to the RF Generator via the Main Cable. The Dispersive Electrode is place on the appropriate location of the body and is connected to its port on the RF Generator. Once the system is successfully powered up, the user can set the parameters of the ablation such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the electrosurgical device placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the RF Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the liquid crystal display (LCD). The RF energy delivery also automatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can be stopped at any time by pressing the RF ON/OFF switch.
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics. The document is a 510(k) summary for the RITA Model 1500 Electrosurgical RF Generator, which focuses on regulatory approval rather than detailed performance study results against predefined acceptance criteria.
The "Performance Data" section vaguely states: "The Model 1500 RF Generator was subjected to a battery of electrical, mechanical, and software validation testing." However, it does not provide any specifics about:
- Acceptance Criteria: No defined metrics or thresholds for performance are listed.
- Reported Device Performance: No actual results from the validation testing are provided.
- Study Design Details: Information regarding sample size, data provenance, ground truth establishment, expert involvement, adjudication methods, or comparative effectiveness studies is absent.
- Standalone Performance: While electrical, mechanical, and software validation testing might imply standalone performance, no specific results or metrics are given.
Therefore,Based on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and performance studies.
§ 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.