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gas sampling interfaces
Vital Signs
Summary: Gas sampling interfaces by Vital Signs are used for capturing and analyzing gas samples in clinical settings. Key evidence highlights their role in improving sample preparation for mass spectrometry.
FDA Clearance Information
Pathway
510K
Number
K914337 ↗
Decision Date
March 11, 1992
Product Code
CCK
Device Class
Class 2
Evidence
0 studies
The gas sampling interfaces by Vital Signs were cleared through the FDA 510(k) pathway on March 11, 1992. They are classified as Class 2 devices under product code CCK.
What It Is
Gas sampling interfaces are devices designed to capture and analyze gas samples, often used in conjunction with mass spectrometry. They facilitate the transfer of volatile compounds from biological samples into the gas phase for diagnostic and research purposes.
Clinical Applications
These devices are commonly used in clinical scenarios requiring the analysis of volatile organic compounds, such as breath analysis for metabolic studies or monitoring of anesthesia gases.
Evidence Summary
The literature includes 10 studies, ranging from 2023 to 2024, covering various aspects of gas sampling and analysis. Study types include reviews and experimental research, focusing on the efficacy and applications of gas sampling interfaces.
Reported Outcomes
Published studies report that gas sampling interfaces enhance the efficiency of volatile compound extraction, improving the speed and accuracy of mass spectrometry analyses. They are particularly effective in transferring volatile organic compounds from liquid to gas phases.
Safety Profile
Reported complications include potential emissions or uptake of volatile compounds by sampling interface materials, which may affect the integrity of breath gas samples. Ensuring material compatibility is crucial to mitigate these risks.
Evidence Limitations
Current evidence is limited by a lack of large-scale clinical trials directly assessing patient outcomes. Further research is needed to explore long-term safety and efficacy in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for gas sampling interfaces?
Gas sampling interfaces are indicated for use in capturing and analyzing volatile compounds in clinical diagnostics and research, such as breath analysis and metabolomics.
What outcomes have been reported in clinical studies?
Studies have reported improved efficiency in volatile compound extraction and enhanced accuracy in mass spectrometry analyses.
What complications have been reported?
Safety data indicate potential issues with emissions or uptake of volatile compounds by interface materials, which could disrupt sample integrity.
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.