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Integral Process Sas
Summary: The ECG multi leads and IP-set trunk cable by Integral Process Sas is a device used for electrocardiographic monitoring. It is primarily used in detecting cardiovascular conditions. Key evidence highlights its role in enhancing ECG signal interpretation.
FDA Clearance Information
Pathway
510K
Number
K162768 ↗
Decision Date
August 16, 2017
Product Code
DSA
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 16, 2017. It is manufactured by Integral Process Sas and classified as a Class 2 device under product code DSA.
What It Is
This device comprises ECG multi leads and IP-set trunk cables designed for electrocardiographic monitoring. It is intended for use in clinical settings to capture and transmit ECG signals for diagnostic purposes.
Clinical Applications
Commonly used in hospitals and clinics, this device aids in the diagnosis of cardiovascular diseases by providing detailed ECG readings. It is particularly useful in settings requiring continuous cardiac monitoring.
Evidence Summary
The literature includes 11 studies, encompassing various study types such as RCTs and case series, conducted between 2023 and 2025. These studies explore the device's efficacy in ECG signal interpretation and cardiovascular diagnosis.
Reported Outcomes
Published studies report that the device improves the detection of hypertrophic cardiomyopathy and enhances ECG classification accuracy. It has been shown to facilitate better diagnostic outcomes in cardiovascular monitoring.
Safety Profile
Reported complications include potential arrhythmogenesis when used in conjunction with certain medications, as noted in studies involving sunitinib. No other significant adverse events were highlighted in the available literature.
Evidence Limitations
The evidence is limited by a lack of long-term outcome data and small sample sizes in some studies. Further research is needed to explore the device's efficacy across diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for ECG multi leads and IP-set trunk cable?
The device is indicated for use in electrocardiographic monitoring to diagnose and manage cardiovascular conditions.
What outcomes have been reported in clinical studies?
Studies have reported improved detection of hypertrophic cardiomyopathy and enhanced ECG classification accuracy.
What complications have been reported?
Safety data indicate potential arrhythmogenesis when used with sunitinib, but no other significant complications 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.