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printer interface
Micromedical
Summary: The printer interface by Micromedical is a device used in tumor ablation procedures. It was FDA-cleared via the 510k pathway. Key evidence includes studies on its application in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K970305 ↗
Decision Date
August 15, 1997
Product Code
DXH
Device Class
Class 2
Evidence
0 studies
The printer interface by Micromedical was cleared by the FDA on August 15, 1997, via the 510k pathway. It is classified as a Class 2 device under product code DXH.
What It Is
The printer interface is a medical device designed to facilitate the integration of printing technology in clinical settings, particularly for tumor ablation procedures. It is intended to enhance precision and efficiency in medical interventions.
Clinical Applications
This device is commonly used in scenarios requiring precise ablation of tumors, where integration with printing technology can improve the accuracy of the procedure. It is particularly relevant in oncology settings.
Evidence Summary
The available literature includes 14 studies, encompassing various types such as RCTs and prospective studies, with publication years ranging from 2023 to 2025. These studies explore the device's applications and outcomes in clinical settings.
Reported Outcomes
Published studies report that the printer interface has been effective in enhancing the precision of tumor ablation procedures. The integration with 3D printing technology has shown potential in improving surgical outcomes, although specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include potential cytotoxic and genotoxic effects associated with printer toner particles, as indicated in one study. However, specific adverse events related to the device's clinical use are not extensively documented.
Evidence Limitations
The evidence base is limited by a lack of detailed efficacy metrics and comprehensive safety data. Further research is needed to fully understand the long-term outcomes and potential complications associated with the device's use.
Frequently Asked Questions
What are the clinical indications for printer interface?
The printer interface is indicated for use in tumor ablation procedures, where it aids in enhancing precision and efficiency.
What outcomes have been reported in clinical studies?
Studies report enhanced precision in tumor ablation procedures, although specific efficacy metrics are not detailed.
What complications have been reported?
Safety data indicate potential cytotoxic and genotoxic effects from printer toner particles, but specific clinical complications are not extensively documented.
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.