(34 days)
The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surpical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers.
The Erbe electrodes and are to be sold with and without a pre-attached cable. Erbe will offer the Return Electrodes without the pre-attached cable as these provide the user the option of purchasing a less expensive item and utilizing a re-usable cable.
The provided document is a 510(k) Notification for the ERBE Disposable Patient Return Electrode from 1996. It is a summary of safety and effectiveness for a conventional medical device (an electrosurgical electrode), not an AI/ML-powered device. Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable and not present in this document.
The document focuses on demonstrating substantial equivalence to existing devices and technologies, common for a 510(k) submission for this type of device. It states that "The ERBE Disposable Patient Return Electrodes utilize the same materials and technology" as those manufactured by ConMed and that "there are no known adverse reactions or field problems with electrodes utilizing this technology or materials."
Therefore, it is not possible to provide the requested information based on the provided text. The prompt's questions are designed for AI/ML device evaluations, which involve different types of performance metrics and study designs compared to the conventional device described here.
{0}------------------------------------------------
February 2, 1996
510(k) Notification ERBE Disposable Patient Return Electrode
MAR 11 1996
Summary of Safety and Effectiveness
This S10(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
For more than 50 years, high-frequency (HF) surgery has been used to cut and/or coagulate biological tissue using the intrinsic thermal effect of electric current. ERBE has been working intensively during this entire period in the production and distribution of state-of-theart HF surgical instruments and accessories. The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surpical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers.
The Erbe electrodes and are to be sold with and without a pre-attached cable. Erbe will offer the Return Electrodes without the pre-attached cable as these provide the user the option of purchasing a less expensive item and utilizing a re-usable cable.
Disposable return electrodes have been manufactured and distributed worldwide by ConMed and the ERBE Disposable Return Electrodes utilize the same materials and technology. There are no known adverse reactions or field problems with electrodes utilizing this technology or materials
It is Erbe's intention to apply for ISO Registration and market this product under the CE mark. It is Erbe policy that all product marketed under the Erbe name are so registered.
Based upon the documents enclosed in this Notification, we believe the ERBE Disposable Patient Return Electrodes are Safe and Effective for their intended purpose when used in accordance with the Instructions for Use.
§ 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.