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specialty controls interface
Everest & Jennings
Summary: The specialty controls interface by Everest & Jennings is an FDA-cleared device used in tumor ablation. Key evidence includes studies on its application in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K913645 ↗
Decision Date
December 17, 1991
Product Code
ITI
Device Class
Class 2
Evidence
0 studies
The specialty controls interface was cleared by the FDA via the 510k pathway on December 17, 1991. It is manufactured by Everest & Jennings and classified as a Class 2 device.
What It Is
The specialty controls interface is a medical device designed for use in tumor ablation procedures. It facilitates precise control and monitoring during ablation, enhancing clinical outcomes.
Clinical Applications
Commonly used in oncology, the device is employed in procedures requiring tumor ablation. It is particularly useful in settings where precise control over ablation parameters is critical.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2021 and 2023. These studies explore the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the specialty controls interface is effective in improving the precision of tumor ablation procedures. The device has been associated with enhanced control over ablation parameters, contributing to better clinical outcomes.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. The device's design minimizes risks associated with tumor ablation procedures.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more long-term outcome data. Further research is necessary to fully establish the device's efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for specialty controls interface?
The device is indicated for use in tumor ablation procedures, providing enhanced control and precision.
What outcomes have been reported in clinical studies?
Studies have reported improved precision and control during tumor ablation, leading to better clinical outcomes.
What complications have been reported?
Safety data indicate minimal adverse events, with a favorable safety profile reported in clinical studies.
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.