📋 FDA Reference
Trilogy with External System Gating Interface
Summary: The Trilogy with External System Gating Interface by Varian Medical Systems is a medical device used in radiotherapy to enhance treatment precision by synchronizing radiation delivery with patient breathing. It is primarily used by radiation oncologists in cancer treatment centers.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K081188 ↗
Decision Date ?
July 14, 2008
Product Code ?
IYE
Device Class ?
Class 2
Evidence ?
0 studies
The Trilogy with External System Gating Interface was cleared by the FDA via the 510(k) pathway on July 14, 2008. It is manufactured by Varian Medical Systems and classified as a Class 2 device under product code IYE.
What It Is
The Trilogy with External System Gating Interface is a sophisticated radiotherapy device designed to improve the accuracy of radiation delivery by accounting for patient movement, particularly breathing. It employs external sensors to monitor the patient's respiratory cycle, allowing the linear accelerator to deliver radiation precisely when the target tumor is in the optimal position. This reduces the risk of damaging surrounding healthy tissues and enhances treatment efficacy.
FDA-Cleared Indications
- Use with a compatible radiotherapy system to support respiratory-gated radiation treatment.
- Synchronize radiation delivery with externally monitored patient breathing motion.
- Support radiotherapy treatment when respiratory movement may affect the position of the treatment target.
Clinical Applications
- Respiratory-gated external-beam radiotherapy for tumors affected by breathing motion.
- Radiotherapy of thoracic targets, including respiratory-moving lung lesions.
- Radiotherapy of upper-abdominal targets, including lesions affected by diaphragmatic motion.
- Treatment planning and delivery in which an external respiratory signal is used to control or coordinate radiation delivery.
Practical Considerations
- The interface is used with a compatible Varian Trilogy linear accelerator and an external respiratory-monitoring or gating system; compatibility must be confirmed before treatment.
- Accurate setup, respiratory-signal quality, calibration, and verification are required before radiation delivery.
- The system is not an implanted device and is not itself an MRI scanner or MRI implant; MRI compatibility depends on the separate monitoring equipment and the clinical workflow.
- Patients must be able to provide a sufficiently reliable respiratory pattern for the selected gating method; irregular breathing may require an alternative motion-management strategy.
- The device is operated by trained radiation oncology personnel and requires routine quality assurance, maintenance, and safety checks.
Related Literature
The linked study evaluated the effectiveness of linear accelerator gating using real-time electromagnetic tracking. It found that using implanted wireless transponders for real-time feedback on tumor location significantly improved the accuracy of radiation delivery without additional imaging doses to the patient. However, the study noted limitations in correlating external anatomy with internal tumor position, highlighting the importance of precise sensor placement and patient-specific calibration.
Frequently Asked Questions
What is Trilogy with External System Gating Interface used for?
It is used to enhance the precision of radiotherapy by synchronizing radiation delivery with the patient's breathing cycle, particularly for tumors affected by respiratory motion.
What specialties typically use this device?
Radiation oncologists primarily use this device in cancer treatment centers and hospitals for treating thoracic and abdominal tumors.
What are the FDA-cleared indications?
It is cleared for use in radiotherapy to improve treatment accuracy for tumors affected by breathing motion, such as those in the lungs and upper abdomen.
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.