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SIR-Spheres Microspheres Activity Calculator Smac
Summary: The Sir-Spheres Microspheres Activity Calculator (SMAC) is a medical device used to calculate the appropriate dose of microspheres for radioembolization procedures. It is typically used by interventional radiologists in the treatment of liver tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202392 ↗
Decision Date ?
October 23, 2020
Product Code ?
KPS
Device Class ?
Class 2
Evidence ?
11 studies
The Sir-Spheres Microspheres Activity Calculator SMAC was cleared through the FDA 510(k) pathway on October 23, 2020. Manufactured by Sirtex Medical US Holdings, it is classified as a Class 2 device under product code KPS.
What It Is
The Sir-Spheres Microspheres Activity Calculator (SMAC) is a specialized tool designed to assist clinicians in determining the correct activity of yttrium-90 microspheres for radioembolization therapy. This device plays a crucial role in ensuring accurate dosing, which is essential for the effective treatment of hepatic malignancies. By providing precise calculations, it helps optimize therapeutic outcomes while minimizing potential side effects.
FDA-Cleared Indications
- Calculation of the activity of Sir-Spheres microspheres used for selective internal radiation therapy of liver tumors.
- Use as a treatment-planning aid by qualified healthcare professionals in conjunction with Sir-Spheres microspheres and the applicable product labeling.
Clinical Applications
- Calculating the prescribed activity of yttrium-90 microspheres before hepatic radioembolization.
- Supporting treatment planning for patients with liver tumors who are candidates for Sir-Spheres microsphere therapy.
- Helping clinicians incorporate patient-specific treatment parameters into the activity calculation.
Practical Considerations
- The calculator is intended for use with Sir-Spheres microspheres and should not be assumed to be validated for other microsphere products.
- The calculated activity must be reviewed by qualified clinicians and interpreted with the patient's liver function, tumor distribution, vascular anatomy and planned treatment approach.
- The calculator does not replace angiographic mapping, assessment of hepatopulmonary shunting or evaluation for nontarget embolization risk.
- SMAC is a software-based calculation tool rather than an implantable device; MRI compatibility considerations apply to the patient and implanted microspheres, not to the calculator itself.
- Use, handling, storage and disposal of the microspheres must follow the separate product labeling and institutional radiation-safety procedures.
Linked Studies (11)
PubMed • 2024
90Y SIR-Spheres Activity Measurement with New SIROS D-Vial Delivery Kit.
Journal of nuclear medicine technology
View Source →PubMed • 2021
A cost-utility analysis of SIR-Spheres Y-90 resin microspheres versus best supportive care in the treatment of unresectable metastatic colorectal cancer refractory to chemotherapy in the UK.
Journal of medical economics
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
A cost analysis of SIR-Spheres yttrium-90 resin microspheres versus tyrosine kinase inhibitors in the treatment of unresectable hepatocellular carcinoma in France, Italy, Spain and the UK.
Journal of medical economics
View Source →PubMed • 2021
Retrospective SPECT/CT dosimetry following transarterial radioembolization.
Journal of applied clinical medical physics
Retrospective View Source →PubMed • 2020
SIR-Spheres yttrium-90 radioembolization for the treatment of unresectable liver cancers.
Hepatic oncology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
The SIRveNIB and SARAH trials and the role of SIR-Spheres® Y-90 resin microspheres in the management of hepatocellular carcinoma.
Future oncology (London, England)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
Recommendations for SIR-Spheres Y-90 resin microspheres in chemotherapy-refractory/intolerant colorectal liver metastases.
Future oncology (London, England)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
Comparison of the Adverse Event Profile of TheraSphere® with SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma: A Systematic Review.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2015
Primary standardization of SIR-Spheres based on the dissolution of the (90)Y-labeled resin microspheres.
Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine
View Source →PubMed • 2007
Yttrium-90 microspheres (TheraSphere and SIR-Spheres) for the treatment of unresectable hepatocellular carcinoma.
Issues in emerging health technologies
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Sir-Spheres Microspheres Activity Calculator SMAC used for?
It is used to calculate the appropriate dose of yttrium-90 microspheres for radioembolization in liver cancer treatment.
What specialties typically use this device?
Interventional radiologists primarily use this device, often in collaboration with oncologists and hepatologists.
What are the FDA-cleared indications?
The device is indicated for calculating microsphere activity in patients undergoing radioembolization for liver tumors.
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.