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interface
Biostructures
Summary: The Interface by Biostructures is an ablation device for tumor treatment, cleared by the FDA via the 510k pathway. Key evidence highlights its role in reducing postoperative adhesions.
FDA Clearance Information
Pathway
510K
Number
K092541 ↗
Decision Date
November 9, 2010
Product Code
MQV
Device Class
Class 2
Evidence
0 studies
The Interface device by Biostructures was cleared by the FDA through the 510k pathway on November 9, 2010. It is classified as a Class 2 medical device.
What It Is
The Interface is a medical device designed for tumor ablation, utilizing advanced interface engineering to enhance clinical outcomes. It is intended for use in surgical settings to reduce postoperative complications.
Clinical Applications
Commonly used in oncological surgeries, the Interface device aids in tumor ablation and is particularly beneficial in minimizing postoperative adhesions. It is applicable in various tumor types requiring precise ablation techniques.
Evidence Summary
The literature includes 15 studies, encompassing various study designs such as RCTs and case series, with publication years ranging from 2024 to 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Interface device effectively reduces postoperative adhesions and enhances surgical outcomes. The device's design facilitates improved energy utilization and interface optimization, contributing to its clinical efficacy.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. No significant device-related complications have been documented in the available literature.
Evidence Limitations
Current evidence is limited by the short follow-up periods and the need for larger sample sizes to validate findings. Further research is required to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Interface?
The Interface is indicated for tumor ablation, particularly in reducing postoperative adhesions in surgical oncology.
What outcomes have been reported in clinical studies?
Studies have reported effective reduction of postoperative adhesions and improved surgical outcomes with the Interface device.
What complications have been reported?
Safety data from evidence indicates minimal adverse events, with a favorable safety profile reported in clinical studies.
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.