(157 days)
The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.
The EM3 AEM Monitor performs two distinct functions:
- Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
- End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.
The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery.
- For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view
- In bipolar electrosurgery, the EM3 displays the measurement of high-frequency current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation
The EM3 AEM Monitor system comprises two components
- The Monitor or electronic unit.
- A specific or standard ESU Adapter.
An ESU Adapter is an accessory to the Monitor containing cords and connectors, which connect the Monitor to the electrosurgical generator (ESU). Multiple models of ESU Adapters are required due to the wide variety of electrosurgical generators in the marketplace and in use in the hospitals.
Here's a summary of the acceptance criteria and study information for the EM3 AEM Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Predicate EM2 AEM Monitor) | Reported Performance (EM3 AEM Monitor) |
|---|---|---|
| Intended Use | Monopolar active-electrode stray-energy shunting and monitoring and bipolar desiccation end-point monitoring | Identical to EM2 |
| Operating Principle | Monopolar high-frequency current shunting, measuring, threshold detection, and alarming; Bipolar high-frequency ammeter measuring and indicating current; Interruption of electrosurgical current under fault condition by tripping ESU contact quality monitor alarm | Monopolar high-frequency current shunting, measuring, threshold detection, and alarming; Bipolar high-frequency ammeter measuring and indicating current; Direct interruption of electrosurgical current to active electrode under fault condition |
| Materials | Typical electronic wires, connectors, analog and logic components, circuit boards, and enclosures | Same as EM2 |
| Energy Source | Mains power | Identical to EM2 |
| Technology | Discrete logic components, PAL logic device, analog electronics, logic-level relay | FPGA logic device, analog electronics, HF power relays |
| Sterilization | None | None |
| Performance: Shield circuit to ESU return potential impedance | 300 ms (dependent on ESU circuit) |
§ 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.