(131 days)
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No
The device description and intended use describe a passive electrode for electrosurgery, with no mention of AI/ML capabilities or data processing.
No.
The device is a dispersive electrode designed to provide a path for RF energy during electrosurgery, which is a supportive role in a surgical procedure rather than directly providing therapy.
No
Explanation: The device is a dispersive electrode used in electrosurgery to safely return RF energy to the generator. It does not perform any diagnostic function.
No
The device description clearly states it is a "single use, non-sterile dispersive electrode with a pre-attached cord," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during electrosurgery to provide a path for RF energy to return to the generator. This is a function related to a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a dispersive electrode with a hydro-gel adhesive for skin contact. This is a physical component used in a surgical setting, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device's function is entirely within the realm of facilitating an electrosurgical procedure.
N/A
Intended Use / Indications for Use
The CONMED® Surefit™ Dual Dispersive Electrode is intended for use in surgical procedures in which Electrosurgery equipment with contact quality monitoring system is used.
CONMED® Surefit™ Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.
Product codes
GEI, JOS
Device Description
The CONMED® Surefit™ Dual Dispersive Electrode is a single use, non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The CONMED® Surefit™ Dual Dispersive Electrode is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this product for unintended applications could lead to an unsafe condition.
The surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolated the conductive area from surgical fluids.
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
The CONMED® Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Where applicable, specific testing performed was in conformance with the requirements of the following standards:
IEC 60601-2-2:2009 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2 ISO 10993-5: 1999 Biological Evaluation of Medical Devices - Part 5 Tests for cytotoxicity, in vitro methods
ISO 10993-10: 2002/Amd 1:2006 Biological Evaluation of Medical Devices – Tests for Irritation and delayed-type hypersensitivity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo for CONMED Electrosurgery. The logo features a stylized crescent shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "ELECTROSURGERY" in a smaller, sans-serif font, underlined by a thin line.