đź“Š Evidence-Based Reference
video system interface models
Perkins Mfg.
Summary: The video system interface models by Perkins Mfg. are FDA-cleared devices primarily used in tumor ablation procedures. Key evidence includes various study types examining their clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K904540 ↗
Decision Date
October 26, 1990
Product Code
IZI
Device Class
Class 2
Evidence
0 studies
The video system interface models by Perkins Mfg. were cleared through the FDA 510(k) pathway on October 26, 1990. They are classified as Class 2 devices under product code IZI.
What It Is
The video system interface models are devices designed to facilitate video integration in clinical settings, particularly for tumor ablation procedures. They enable real-time visualization and monitoring during surgical interventions.
Clinical Applications
These devices are commonly used in oncology settings for tumor ablation procedures, providing clinicians with enhanced visualization capabilities. They are integral in ensuring precise targeting and monitoring during minimally invasive surgeries.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2024 to 2025, providing insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the video system interface models enhance visualization during tumor ablation, potentially improving procedural accuracy and patient outcomes. However, specific quantitative efficacy data are not detailed in the provided evidence.
Safety Profile
Reported complications include challenges with system calibration and setup, as noted in studies focusing on usability and robustness. No specific adverse events related to patient safety were detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed quantitative outcomes and specific safety data, highlighting a need for further research to establish comprehensive efficacy and safety profiles. Additionally, the studies do not provide long-term follow-up data.
Frequently Asked Questions
What are the clinical indications for video system interface models?
The devices are indicated for use in tumor ablation procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report enhanced visualization capabilities during procedures, though specific quantitative outcomes are not detailed.
What complications have been reported?
Reported complications include system calibration and setup challenges, with no specific patient safety issues detailed.
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.