(34 days)
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No
The summary describes a disposable patient return electrode, a passive accessory for electrosurgical generators, with no mention of AI or ML capabilities.
No.
The device is a return electrode used with high-frequency surgical instruments, which are used to cut or coagulate tissue during surgery. It is an accessory to a surgical instrument, not a therapeutic device itself.
No
The device, ERBE Disposable Patient Return Electrodes, is an accessory for electrosurgical generators, used in the application of high-frequency surgical instruments. Its function is to facilitate the surgical process by providing a return path for the electrical current, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a "Disposable Patient Return Electrode" and describes physical components like electrodes and cables, indicating it is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an accessory for "HF surgical instruments" and "Electrosurgical Generators." This indicates a use in surgical procedures, not in the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical components and how they connect to surgical equipment.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Use in a laboratory setting
Therefore, the ERBE Disposable Patient Return Electrodes are a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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.