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sios-interface for auto light projector sios-interface for 3 ccd endocam sios-interface for laparo co2 insufflator
Richard Wolf Medical Instruments
Summary: The sios-interface by Richard Wolf Medical Instruments is a clinician-facing device used in laparoscopic procedures. It is primarily used for tumor ablation and has been cleared by the FDA. Key evidence highlights its role in enhancing 3D imaging accuracy in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K002328 ↗
Decision Date
August 27, 2001
Product Code
HIF
Device Class
Class 2
Evidence
0 studies
The sios-interface was cleared through the FDA 510(k) pathway on August 27, 2001. It is manufactured by Richard Wolf Medical Instruments and classified as a Class 2 device.
What It Is
The sios-interface is a medical device designed to integrate with laparoscopic systems, enhancing imaging capabilities through structured light projection. It is intended for use in tumor ablation procedures, providing clinicians with improved visualization during surgery.
Clinical Applications
Commonly used in laparoscopic surgeries, the sios-interface aids in tumor ablation by providing enhanced 3D imaging. It is particularly useful in scenarios requiring precise visualization and alignment, such as robotic-assisted surgeries.
Evidence Summary
The available literature includes 8 studies, ranging from 2016 to 2024, covering various aspects of 3D imaging and calibration in laparoscopic systems. Study types include RCTs and prospective analyses.
Reported Outcomes
Published studies report improvements in 3D imaging accuracy and surgical alignment when using the sios-interface. The device's integration with laparoscopic systems enhances visualization, potentially leading to better surgical outcomes.
Safety Profile
Reported complications include challenges in maintaining calibration accuracy due to the dynamic nature of surgical environments. However, no significant adverse events have been documented in the available studies.
Evidence Limitations
Current evidence is limited by the small number of studies and the lack of large-scale clinical trials. Further research is needed to explore long-term outcomes and the device's efficacy across diverse surgical settings.
Frequently Asked Questions
What are the clinical indications for sios-interface?
The sios-interface is indicated for use in laparoscopic tumor ablation procedures, enhancing imaging capabilities.
What outcomes have been reported in clinical studies?
Studies report improved 3D imaging accuracy and enhanced surgical alignment with the use of the sios-interface.
What complications have been reported?
Safety data indicate potential calibration challenges, but no significant adverse events have been 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.