Content Considerations for Superficial and Interstitial Photon-Emitting Radionuclide Brachytherapy Sources
This guidance applies to superficial and interstitial photon-emitting Radionuclide Brachytherapy Sources as defined in 21 CFR 892.5730. These are Class II devices consisting of a radionuclide enclosed in a sealed container made of gold, titanium, stainless steel, or platinum, intended for medical purposes. The guidance excludes sources intended for use in the cardiovascular system for restenosis prevention.
What You Need to Know? 👇
What are the key differences between traditional, special, and abbreviated 510(k) submissions for brachytherapy sources?
Traditional 510(k)s require full data review. Special 510(k)s for device modifications use design controls and are processed within 30 days. Abbreviated 510(k)s rely on conformance to voluntary standards instead of experimental data, making review more efficient.
Which voluntary standards apply to photon-emitting brachytherapy sources for 510(k) submissions?
Key standards include ANSI N43.6-1997 for classification of sealed radioactive sources, ISO 2919 for general requirements and classification, and NIST calibration standards for specific radionuclides and source encapsulation.
What source output information must be included in a brachytherapy source 510(k) submission?
You must specify the physical quantity used (air-kerma strength, apparent activity), accuracy/uncertainty levels, measurement methods for single and multi-seed sources, dose distribution data, and normalization procedures to source output specifications.
How should traceability to national standards be demonstrated for brachytherapy source calibration?
Calibration must be traceable to NIST through direct calibration or via an accredited laboratory that passed NIST proficiency testing. A routine quality control program must ensure the manufacturing calibration system operates within statistical limits.
What dosimetric information is required in the labeling for brachytherapy sources?
Labeling must include recommended dosimetric models, parameter values, source output specifications, calibration reference time, air-kerma strength values, conversion factors, independent parameter determinations, and isodose curves from 90% to 10% maximum dose.
What are the main components that must be described in brachytherapy source design documentation?
You must identify encapsulation materials, internal substrate composition, source configuration, complete engineering drawings with dimensions, ANSI N43.6-1997 or ISO 2919 compliance status, and sealed source certificates from regulatory authorities.
What You Need to Do 👇
Recommended Actions
- Ensure source design meets ANSI N43.6-1997 or ISO 2919 standards
- Establish traceable calibration system to NIST
- Develop comprehensive quality system for manufacturing
- Prepare detailed source documentation including engineering drawings
- Conduct and document source output measurements and dose distribution
- Create complete labeling package with all required information
- Obtain sealed source certificate from regulatory authority
- Prepare verification and validation documentation if using calculation software
- Establish procedures for leak testing, sterilization, and disposal
- Document dosimetric models and parameters with independent validations
Key Considerations
Non-clinical testing
- Source output measurements and dose distribution verification
- Calibration system must be traceable to NIST or equivalent national standard
- Dosimetric properties validation with at least two independent determinations
- Isodose curves documentation from 90% to 10% of maximum dose
Software
- If using calculational techniques (e.g., Monte Carlo), verification and validation procedures must be documented
Labelling
- Indications for use
- Single/multiple use specification
- Contraindications, warnings, precautions
- Source physical properties and dimensions
- Shelf life
- Implantation method
- Sterilization methods
- Disposal methods
- Dosimetric properties and models
- Source output verification procedures
Safety
- Leak test procedures
- Source encapsulation classification according to standards
- Sealed source certificate from regulatory authority
- Quality system for manufacturing specifications
Other considerations
- Source material information including radionuclide identification and properties
- Source design and encapsulation details
- Manufacturing process information
Relevant Guidances 🔗
- Content of Premarket Submissions for Device Software Functions
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Unique Device Identifier (UDI) Form and Content Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms 📂
- ANSI N43.6-1997: Classification of Sealed Radioactive Sources
- ISO 2919: Sealed radioactive sources—General requirements and classification