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pump connectivity interface
Baxter Healthcare
Summary: The pump connectivity interface by Baxter Healthcare is a device used in tumor ablation procedures. It was FDA-cleared via the 510(k) pathway. Key evidence includes studies on device interoperability and safety.
FDA Clearance Information
Pathway
510K
Number
K040985 ↗
Decision Date
November 30, 2004
Product Code
FRN
Device Class
Class 2
Evidence
0 studies
The pump connectivity interface was cleared by the FDA through the 510(k) pathway on November 30, 2004. It is manufactured by Baxter Healthcare and is classified as a Class 2 device.
What It Is
The pump connectivity interface is designed to facilitate communication between medical devices used in tumor ablation procedures. It ensures seamless integration and data exchange, enhancing the precision and effectiveness of ablation therapies.
Clinical Applications
This device is commonly used in clinical settings where tumor ablation is performed, such as oncology departments. It is crucial for ensuring that ablation devices operate in a coordinated manner, improving treatment outcomes.
Evidence Summary
The literature includes 10 studies, encompassing various types such as RCTs and prospective studies, published between 2019 and 2025. These studies focus on device interoperability and safety in clinical settings.
Reported Outcomes
Published studies report that the pump connectivity interface enhances device interoperability, leading to improved treatment precision in tumor ablation. The evidence suggests that the interface contributes to better clinical outcomes by ensuring reliable communication between devices.
Safety Profile
Reported complications include potential device communication errors, which could impact treatment efficacy. However, the studies generally indicate a favorable safety profile with minimal adverse events.
Evidence Limitations
The evidence is limited by the small number of studies specifically addressing long-term outcomes. Further research is needed to explore the interface's impact on different tumor types and patient populations.
Frequently Asked Questions
What are the clinical indications for pump connectivity interface?
The device is indicated for use in tumor ablation procedures to ensure effective communication between medical devices.
What outcomes have been reported in clinical studies?
Studies report improved device interoperability and treatment precision, contributing to better clinical outcomes in tumor ablation.
What complications have been reported?
Safety data indicate potential communication errors, but overall, the device has a favorable safety profile with minimal adverse events.
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.