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datex-ohmeda s 5 device interfacing solution n-disxxxx
Datex-Ohmeda
Summary: The Datex-Ohmeda S 5 Device Interfacing Solution N-DISXXXX is a medical device used in tumor ablation procedures. It is FDA 510k cleared and linked to studies exploring user interface and speech interaction in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K012531 ↗
Decision Date
November 2, 2001
Product Code
MSX
Device Class
Class 2
Evidence
0 studies
The Datex-Ohmeda S 5 Device Interfacing Solution N-DISXXXX was cleared through the FDA 510k pathway on November 2, 2001. It is manufactured by Datex-Ohmeda and classified as a Class 2 device.
What It Is
The Datex-Ohmeda S 5 Device Interfacing Solution N-DISXXXX is designed to facilitate the integration of medical devices in clinical settings, particularly for tumor ablation procedures. It aims to enhance the functionality and usability of medical equipment through improved interfacing solutions.
Clinical Applications
This device is commonly used in clinical scenarios involving tumor ablation, where precise device integration and monitoring are critical. It supports clinicians in managing complex procedures by streamlining device interactions.
Evidence Summary
The available literature includes two studies published between 2003 and 2006. These studies explore the user interface and potential for speech interaction with the device, highlighting areas for improvement in clinical settings.
Reported Outcomes
Published studies report that the device's user interface may be confusing, potentially impacting clinical workflow. Another study suggests that speech interaction technology could address some interaction challenges, enhancing documentation processes during anesthesia.
Safety Profile
Reported complications include potential confusion due to the device's user interface, which may affect clinical efficiency. No specific adverse events or safety concerns were detailed in the provided studies.
Evidence Limitations
The evidence is limited to two studies, primarily focusing on user interface and interaction aspects rather than clinical efficacy or safety outcomes. Further research is needed to evaluate the device's impact on clinical outcomes and patient safety comprehensively.
Frequently Asked Questions
What are the clinical indications for Datex-Ohmeda S 5 Device Interfacing Solution N-DISXXXX?
The device is indicated for use in tumor ablation procedures, facilitating device integration and monitoring.
What outcomes have been reported in clinical studies?
Studies highlight potential user interface confusion and suggest speech interaction as a solution for improving clinical workflow.
What complications have been reported?
Safety data indicate potential confusion with the user interface, but no specific adverse events were 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.