THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES

• K Number: K140658
• Device Name: THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
• Manufacturer: CONMED CORPORATION
• Date Cleared: 2014-07-10 ( 118 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K972628

Intended Use

The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes are used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the active electrode during electrosurgical procedures.

Device Description

The ConMed ThermoGard® and ThermoGard® Plus ABC 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 ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is designed for use with electrosurgical generators equipped with either continuity monitors or contact quality monitoring systems. The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is composed of a non-conductive border adhesive surrounding the entire conductive gel area to ensure full contact with the patient's skin, and a pre-attached cordset.

AI/ML Overview

The provided document is a 510(k) summary for the ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with explicit performance metrics.

Based on the document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it relies on demonstrating compliance with recognized standards and biocompatibility.

• Acceptance Criteria (Implied from the document):

  • Performance equivalent to predicate device.
  • Compliance with AAMI / ANSI ES60601-1:2005/(R) 2012 and C1:2009/(R)2012 A2:2010/(R)2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
  • Compliance with IEC 60601-2-2 Edition 5.0: 2009 (Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories).
  • Biocompatibility per ISO 10993-1:2009 (Biological Evaluation of Medical Devices Evaluation and Testing within a Risk Management Process) for new patient contacting materials.
  • No new issues of safety or efficacy due to minor design changes (dimensions, construction).

• Reported Device Performance:

  • The document states, "The proposed devices are equivalent to the predicate devices in their technological characteristics and performance."
  • It also states, "Both devices demonstrate compliance with applicable sections of AAMI / ANSI ES60601-1:2005/(R) 2012 and C1:2009/(R)2012 A2:2010/(R)2012... and IEC 60601-2-2 Edition 5.0: 2009..."
  • "Materials analysis demonstrates the ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode materials comply with the requirements of ISO 10993-1:2009 Biologica Evaluation of Medical Devices Evaluation and Testing within a Risk Management Process."
  • "Design testing was performed to verify that none of the changed features would affect equivalence."
  • "New patient contacting materials were tested per ISO 10993 and verified to be biocompatible."

  Note: Specific quantitative performance metrics (e.g., impedance, temperature rise) against detailed acceptance limits are not provided in this summary. The "study" mentioned is effectively a series of non-clinical tests to verify compliance with standards and equivalence to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify a "test set" in the context of clinical data or a dataset with a specific sample size. The testing described is non-clinical (design testing, materials analysis, compliance with standards). Therefore, information on data provenance or whether it was retrospective or prospective is not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device's "ground truth" (compliance with safety and performance standards) was established through engineering design testing and materials analysis, not through expert consensus on a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable, as there is no mention of a human-adjudicated test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a medical accessory (dispersive electrode) and not an AI-driven image analysis or diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device, in the context of this 510(k) submission, is established by:

• Compliance with recognized industry standards: AAMI / ANSI ES60601-1 and IEC 60601-2-2 for electrical safety and performance.
• Biocompatibility testing: Conformance to ISO 10993-1.
• Equivalence to a legally marketed predicate device: Demonstrating that the changes do not raise new safety or efficacy issues.

There is no mention of clinical ground truth derived from expert consensus, pathology, or outcomes data in this summary.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical accessory, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the reasons mentioned in point 8.

Regulation Number and Section

§ 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.