📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use with the INTRABEAM system to deliver intraoperative radiotherapy.
- Convert the spherical dose distribution of the INTRABEAM X-ray source into a flat dose distribution.
- Apply radiation to flat treatment areas up to approximately 6 cm in diameter.
Clinical Applications
- Intraoperative radiotherapy of selected flat tumor beds after surgical removal of a tumor.
- Treatment of superficial or surface areas when a flat radiation field is appropriate.
- Use during surgery when the treatment margin is close to or positive, where the treating team determines that IORT is appropriate.
- Selected dermatologic or other superficial oncologic applications involving a flat area within the applicator's treated diameter.
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.
Practical Considerations
- The applicators are designed for use with the compatible INTRABEAM system and are not general-purpose external-beam radiation applicators.
- The flat and surface applicator geometry is intended for treatment areas up to approximately 6 cm in diameter; the treating radiation oncology team must select the appropriate size and position.
- Treatment is performed in the operating room under the direction of the surgical and radiation oncology teams, with shielding and radiation-safety procedures.
- These are radiotherapy applicators, not MRI devices. MRI compatibility should not be assumed; follow the manufacturer's labeling and institutional safety policy.
- Suitability depends on tumor location, tissue depth, wound geometry, dose planning, and the patient's overall treatment plan. Surgery, external-beam radiation, systemic therapy, or observation may also be appropriate.
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.