đź“Š Evidence-Based Reference
gas sampling interfaces
Coast Medical
Summary: Gas sampling interfaces by Coast Medical are used for capturing volatile compounds in clinical settings. Key evidence highlights their role in enhancing the accuracy of breath analysis by minimizing sample contamination.
FDA Clearance Information
Pathway
510K
Number
K943110 ↗
Decision Date
August 19, 1994
Product Code
BYX
Device Class
Class 1
Evidence
0 studies
The gas sampling interfaces by Coast Medical were cleared through the FDA 510(k) pathway on August 19, 1994. They are classified as Class 1 devices under product code BYX.
What It Is
Gas sampling interfaces are devices designed to capture and analyze volatile compounds from clinical samples, such as breath. They are intended for use in diagnostic and monitoring applications, particularly in the context of tumor ablation devices.
Clinical Applications
These interfaces are commonly used in clinical scenarios requiring precise analysis of volatile organic compounds, such as breath analysis for diagnostic purposes. They are particularly useful in settings where accurate detection of gas-phase analytes is critical.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as reviews and trials, conducted between 2023 and 2024. These studies explore the efficacy and safety of gas sampling interfaces in clinical applications.
Reported Outcomes
Published studies report that gas sampling interfaces enhance the accuracy of volatile compound detection in clinical samples. They are effective in minimizing contamination and improving the reliability of breath analysis data. The interfaces are also noted for their role in facilitating rapid and efficient sample preparation.
Safety Profile
Reported complications include potential emissions or uptake of volatile organic compounds by the sampling materials, which could affect sample integrity. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of clinical trials and the focus on specific applications. Further research is needed to explore the full range of clinical scenarios and to validate findings across diverse patient populations.
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 samples, particularly in tumor ablation contexts.
What outcomes have been reported in clinical studies?
Studies report improved accuracy in volatile compound detection and enhanced reliability of breath analysis data.
What complications have been reported?
Safety data indicate potential sample contamination due to emissions or uptake by sampling materials, but no major 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.