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disposable adhesive surface electrode
Spes Medica Srl
Summary: The disposable adhesive surface electrode by Spes Medica Srl is primarily used for tumor ablation. Key evidence highlights its application in sensitive electrochemical biosensing.
FDA Clearance Information
Pathway
510K
Number
K120494 ↗
Decision Date
June 11, 2012
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on June 11, 2012. It is manufactured by Spes Medica Srl and classified as a Class 2 medical device.
What It Is
The disposable adhesive surface electrode is designed for clinical applications involving tumor ablation. It functions by adhering to the skin to facilitate electrical signal conduction.
Clinical Applications
Commonly used in scenarios requiring precise electrical signal monitoring or delivery, such as in tumor ablation procedures. It provides a non-invasive method for clinical diagnostics.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2022 and 2024. These studies explore the device's applications in biosensing and muscle activity monitoring.
Reported Outcomes
Published studies report the device's efficacy in sensitive detection of biomarkers and cells, such as carcinoembryonic antigen and HeLa cells, using electrochemical methods. Its application in muscle activity estimation through surface EMG is also noted.
Safety Profile
Reported complications include potential skin irritation from adhesive use and the cost implications of disposable components. No severe adverse events were documented in the available studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and the focus on specific applications like biosensing. Further research is needed to explore broader clinical applications and long-term safety.
Frequently Asked Questions
What are the clinical indications for disposable adhesive surface electrode?
The device is indicated for use in tumor ablation and electrochemical biosensing applications.
What outcomes have been reported in clinical studies?
Studies report effective detection of biomarkers and muscle activity monitoring using the electrode.
What complications have been reported?
Safety data indicate potential skin irritation and cost concerns related to disposable use.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.