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tri-optic measurement cell with balance biosurface with carmeda bioactive surface with trillium biosurface with 6
Medtronic
Summary: The tri-optic measurement cell by Medtronic is an ablation device used primarily for tumor treatment. It is FDA 510k cleared, with limited evidence available from three studies, none of which provide detailed outcomes or safety data.
FDA Clearance Information
Pathway
510K
Number
K133157 ↗
Decision Date
October 23, 2014
Product Code
DRY
Device Class
Class 2
Evidence
0 studies
The tri-optic measurement cell was cleared by the FDA through the 510k pathway on October 23, 2014. It is manufactured by Medtronic and classified as a Class 2 device under product code DRY.
What It Is
The tri-optic measurement cell is a medical device designed for tumor ablation. It utilizes a balance biosurface with a carmeda bioactive surface to enhance its clinical efficacy. The device is intended for use in the treatment of tumors, providing a minimally invasive option for clinicians.
Clinical Applications
This device is commonly used in clinical scenarios involving tumor ablation. It is particularly useful in cases where traditional surgical methods are not viable, offering a less invasive alternative for tumor management.
Evidence Summary
The available literature consists of three studies registered on ClinicalTrials.gov. However, these studies do not provide specific data on outcomes or safety related to the tri-optic measurement cell. The studies are of unknown type and lack detailed abstracts or results.
Reported Outcomes
Published studies report no specific efficacy findings for the tri-optic measurement cell. The available evidence does not include detailed outcomes, making it difficult to assess the device's clinical effectiveness.
Safety Profile
Reported complications include no specific safety data from the provided studies. The lack of detailed safety information highlights a gap in the current evidence base.
Evidence Limitations
The evidence for the tri-optic measurement cell is limited, with no detailed outcomes or safety data available from the linked studies. Further research is needed to establish the device's efficacy and safety profile in clinical practice.
Frequently Asked Questions
What are the clinical indications for tri-optic measurement cell?
The device is indicated for tumor ablation, providing a minimally invasive treatment option.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the available studies.
What complications have been reported?
The available evidence does not report specific complications or safety data.
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.