📊 Evidence-Based Reference
Modification to Cyberknife Robotic Radiosurgery System
Accuray
Summary: The CyberKnife Robotic Radiosurgery System is a non-invasive treatment device for delivering precise radiation therapy. It is primarily used for stereotactic radiosurgery in various cancers. Key evidence highlights its surgical precision and submillimeter accuracy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K091146 ↗
Decision Date ?
May 1, 2009
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The CyberKnife Robotic Radiosurgery System by Accuray was cleared by the FDA via the 510(k) pathway on May 1, 2009. It is classified as a Class 2 device under product code MUJ.
What It Is
The CyberKnife is a robotic radiosurgery system that uses a compact linear accelerator mounted on a robotic arm to deliver high-dose radiation with precision. It is intended for the treatment of tumors and lesions in various parts of the body, offering a non-invasive alternative to traditional surgery.
FDA-Cleared Indications
- Delivery of precisely targeted radiation therapy for tumors and lesions when stereotactic radiosurgery or stereotactic body radiation therapy is clinically appropriate.
- Treatment of lesions in multiple anatomic regions using image-guided robotic radiation delivery.
- Use as a noninvasive alternative to selected surgical procedures or conventional radiation therapy when determined appropriate by the treating team.
Clinical Applications
- Image-guided stereotactic radiosurgery for selected intracranial tumors and lesions.
- Stereotactic body radiation therapy for selected tumors outside the brain, including lesions in the lung, liver, spine, prostate, or kidney when appropriate.
- Treatment of tumors that are difficult to reach surgically or that may carry substantial surgical risk.
- Fractionated stereotactic radiation delivered over multiple treatment sessions when clinically indicated.
Reported off-label uses
- Selected reirradiation treatments after prior radiation, when evaluated by a specialist radiation oncology team.
- Palliative radiation for selected symptomatic tumors when stereotactic dosing is appropriate.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes a mix of retrospective and prospective studies, with a total of 6 studies identified. These studies span from 2008 to recent years, highlighting the system's precision and application in various cancers.
Reported Outcomes
Published studies report that the CyberKnife system achieves surgical precision in radiation delivery, with submillimeter accuracy confirmed through quality assurance techniques. It has been used effectively in treating neurinomas, breast cancer, and brain metastases, demonstrating its versatility and efficacy.
Safety Profile
Reported complications include the need for rigorous quality assurance due to the system's complexity. No specific adverse events are detailed in the provided evidence, but the importance of precise calibration and monitoring is emphasized.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and long-term follow-up data. Further research is needed to establish comprehensive safety profiles and long-term efficacy across diverse patient populations.
Practical Considerations
- The system is an external treatment platform, not an implanted device; it does not have a patient-specific implant size or vessel compatibility requirement.
- Treatment planning requires high-quality imaging, such as CT or MRI, and precise patient positioning or motion tracking.
- MRI is used for planning in many cases, but the treatment system itself is not an MRI scanner; MRI safety depends on the separate scanner, accessories, and any implanted devices.
- Treatment may require one or several outpatient sessions, depending on tumor location, size, dose, motion, and the treatment plan.
- Suitability depends on tumor size and location, prior radiation, ability to remain positioned, and protection of nearby organs; surgery, conventional radiation, systemic medication, or observation may be more appropriate in some cases.
Frequently Asked Questions
What are the clinical indications for CyberKnife Robotic Radiosurgery System?
The CyberKnife is indicated for the treatment of tumors and lesions in various parts of the body, including brain metastases, early-stage breast cancer, and renal cancer.
What outcomes have been reported in clinical studies?
Studies report high precision in radiation delivery with submillimeter accuracy, effective treatment of neurinomas, breast cancer, and brain metastases.
What complications have been reported?
Reported complications include the necessity for rigorous quality assurance due to system complexity, with no specific adverse events detailed in the provided evidence.
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.