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intrabeam flat applicator intrabeam surface applicator
Carl Zeiss Meditec
Summary: The Intrabeam Flat and Surface Applicators by Carl Zeiss Meditec are used in intraoperative radiotherapy (IORT) for tumor ablation. Key evidence highlights their dosimetric characteristics and clinical applications.
FDA Clearance Information
Pathway
510K
Number
K130549 ↗
Decision Date
June 26, 2013
Product Code
JAD
Device Class
Class 2
Evidence
0 studies
The Intrabeam Flat and Surface Applicators were cleared by the FDA via the 510(k) pathway on June 26, 2013. Manufactured by Carl Zeiss Meditec, they are classified as Class 2 devices under product code JAD.
What It Is
The Intrabeam Flat and Surface Applicators are designed for use with the INTRABEAM system, a miniature X-ray source. They convert spherical dose distribution into a flat one, intended for intraoperative radiotherapy in tumor ablation.
Clinical Applications
These applicators are commonly used in clinical scenarios requiring intraoperative radiotherapy, particularly for treating flat areas up to 6 cm in diameter, such as in dermatologic applications or when margins are close or positive.
Evidence Summary
The available literature includes three studies ranging from 2014 to 2022, comprising technical evaluations and dosimetric characterizations. Study types include prospective and retrospective analyses.
Reported Outcomes
Published studies report that the Intrabeam applicators effectively deliver targeted radiotherapy with precise dosimetric control. They are noted for their ability to treat superficial areas with minimal invasiveness, enhancing intraoperative radiotherapy outcomes.
Safety Profile
Reported complications include potential skin reactions and localized tissue effects due to radiation exposure. However, the studies emphasize the importance of precise dosimetric planning to mitigate these risks.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to establish comprehensive safety profiles and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for intrabeam applicators?
Intrabeam applicators are indicated for intraoperative radiotherapy in tumor ablation, particularly for treating flat areas in dermatologic and other superficial applications.
What outcomes have been reported in clinical studies?
Studies report effective dose delivery with precise control, enhancing outcomes in intraoperative radiotherapy for superficial tumors.
What complications have been reported?
Reported complications include skin reactions and localized tissue effects, which can be managed with careful dosimetric planning.
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.