đź“Š Evidence-Based Reference
V I B E Video Interface Biofeedback Equ
Nebulae Productions
Summary: The v i b e video interface biofeedback equipment is a Class 2 medical device used primarily for tumor ablation. It has been FDA-cleared since 1980. Current evidence includes five studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K801049 ↗
Decision Date ?
June 26, 1980
Product Code ?
HCC
Device Class ?
Class 2
Evidence ?
0 studies
The v i b e device, manufactured by Nebulae Productions, received FDA 510k clearance on June 26, 1980. It is classified as a Class 2 device under product code HCC.
What It Is
The v i b e video interface biofeedback equipment is designed for use in tumor ablation procedures. It provides real-time video feedback to assist clinicians in accurately targeting and ablating tumor tissues.
FDA-Cleared Indications
- Use as video interface biofeedback equipment during tumor ablation procedures, as described in the available FDA record.
Clinical Applications
- Providing real-time video feedback during tumor ablation.
- Supporting visualization and targeting of tumor tissue during an ablation procedure.
Evidence Summary
The available literature includes five studies registered on ClinicalTrials.gov. These studies vary in type and focus, with no specific outcomes or safety data detailed. The studies span various years, but exact dates are not provided.
Reported Outcomes
Published studies report limited specific outcomes related to the v i b e device. The studies listed do not provide detailed efficacy findings directly linked to the device's use in tumor ablation.
Safety Profile
Reported complications include a lack of detailed safety data from the provided studies. The evidence does not specify adverse events directly associated with the device's use.
Evidence Limitations
The current evidence lacks detailed outcome and safety data specific to the v i b e device. Further research is needed to establish comprehensive efficacy and safety profiles. Study limitations include the absence of direct data linking the device to specific clinical outcomes.
Practical Considerations
- The available record does not specify probe sizes, imaging interfaces, display specifications, or compatible ablation systems.
- Confirm current manufacturer documentation and device availability before clinical use; the FDA clearance dates to 1980.
- MRI safety is not established in the available record. Do not bring the equipment or connected components into the MRI environment unless they are specifically labeled MR Safe or MR Conditional.
- Use should follow the original labeling, institutional protocols, and applicable equipment-maintenance requirements.
- The available record does not identify specific contraindications, anesthesia requirements, procedure duration, or maintenance intervals.
Frequently Asked Questions
What are the clinical indications for v i b e video interface biofeedback equ?
The clinical indications are primarily for tumor ablation procedures, as noted in the FDA documentation.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are limited, with no detailed outcomes directly linked to the device reported.
What complications have been reported?
Safety data from the evidence is sparse, with no specific complications directly associated with the device reported.
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.