(26 days)
The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad, in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.
The Mega 2000 Soft Dual Cord is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric layers of a viscoelastic polymer. (The top layer of polymer is thinner than the bottom layer.) The polymer is encapsulated by a layer of urethane film. Two cables connect the conductive layer of the device to two DetachaCables". The DetachaCable(s) are connected to a standard monopolar electrosurgical unit (ESU). The device cables are insulated and strain-relieved well inside the device to prevent patient or user burns. The device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x ½". In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".
The provided text describes a 510(k) premarket notification for the "Mega 2000 Soft Dual Cord Patient Return Electrode Pad." This document focuses on demonstrating substantial equivalence to a predicate device and safety and performance testing for a medical device that assists in electrosurgery. It is not an AI/ML device, so many of the requested categories (e.g., training set, MRMC study, ground truth for training set) are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Safe Temperature Rise (ANSI/AAMI HF-18, paragraph 4.2.3.1) | "The device is well within the requirements of the standard." (Tested with human volunteers and two electrosurgical generators, with and without a single linen layer between the pad and the patient). Infrared camera used to record temperature changes. |
| Electrode Contact Impedance (Minimum Capacitance Requirement) | "Conformance with the minimum capacitance requirement was demonstrated through bench testing. Device capacitance was evaluated under several different test setups intended to simulate clinical use." |
| Current Limiting ( |
§ 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.