(122 days)
The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
Mygen M-3004 RF System consists of a microprocessor based RF generator, a cooling pump and tubing, electrodes, and ground pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the electrodes causing the coagulation (ablation) of the tissue. Mygen M-3004 RF System generator is capable of delivering up to 200 waits (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature.
The radiofrequency (RF) energy, which is delivered to an electrode, makes frictional heat for coagulation and ablation on diseased tissue by ionic agitation. The patient can receive safe therapy as leakage current is extremely low. Mygen M-3004 continually measures and displays RF output power, tissue impedance, and elapsed time of RF delivery. Tissue temperature is measured by the thermocouple embedded in the electrode tip and is displayed on the touch screen. This equipment automatically adjusts the output to maximize the delivery of high-frequency energy and displays the measured temperature from the treatment site during high-frequency emission.
Mygen M-3004 automatically adjusts the output to optimize radiofrequency output and displays the measured temperature from the treatment area while delivering radiofrequency energy.
This is a 510(k) summary for a medical device called the "Mygen M-3004 RF System," an electrosurgical cutting and coagulation device. The document primarily focuses on establishing substantial equivalence to a predicate device, not on clinical performance or diagnostic accuracy. Therefore, the information requested in your questions, particularly regarding acceptance criteria for diagnostic accuracy, expert review, and training/test set details, is largely not present in this type of submission.
Here's an breakdown of the available information based on your questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria for diagnostic accuracy or performance metrics like sensitivity, specificity, or AUC. Instead, it details performance tests conducted to ensure the device functions as intended and is safe. The "acceptance criteria" here are implicit in the successful completion of these engineering and safety tests, demonstrating compliance with relevant standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Performance | |
| Accuracy of Output | Tests conducted; fulfilled |
| Accuracy of Energy Transfer | Tests conducted; fulfilled |
| Active Electrode Resistor | Tests conducted; fulfilled |
| High Frequency and Mains Frequency Dielectric Strength of Active Electrode | Tests conducted; fulfilled |
| Accuracy of Tip Temperature | Tests conducted; fulfilled |
| High Frequency Leakage of Active Electrode | Tests conducted; fulfilled |
| Biocompatibility | |
| Cytotoxicity | Non-cytotoxic |
| Delayed Hypersensitivity | Non-sensitizer, non-allergenic |
| Intracutaneous Reactivity | Non-skin irritant |
| Pyrogenicity | Free of pyrogens |
| Acute Systemic Toxicity | Not toxic |
| Endotoxin Level |
§ 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.