Premarket Notification Requirements for Radionuclide Dose Calibrators
This guidance applies to Radionuclide Dose Calibrators (RDCs) as defined in 21 CFR 892.1360, which are Class II devices used to assay radionuclides before patient administration. It covers calibrators used in nuclear medicine and brachytherapy, including new RDCs, new components, and significant modifications affecting safety or effectiveness.
Recommended Actions
- Determine appropriate 510(k) submission type (Traditional, Special, or Abbreviated)
- Prepare comprehensive device description including detector type and system components
- Identify and document comparison to predicate device
- Conduct necessary performance testing including calibration, accuracy, and linearity
- Verify electromagnetic compatibility
- Prepare software documentation if applicable
- Develop complete labeling package with all required elements
- Prepare administrative documentation including 510(k) Summary/Statement
- Consider applicable standards compliance and prepare declarations of conformity
- Document all sources of error and their mitigation strategies
Key Considerations
Non-clinical testing
- Initial calibration method must be described with NIST derivable calibration sources
- Common sources of error and their magnitude must be documented
- Activity ranges must be specified
- Accuracy and reproducibility must be demonstrated
- Linearity must be verified
- Background radiation interference must be assessed
Software
- Must follow “Guidance for Content of Premarket Submissions for Software Contained in Medical Devices”
- Year 2000 compatibility must be addressed
- Software functions must be described in labeling
Labelling
- Must include summary specification sheet
- Instructions for use must contain:
- Indications for use
- Contraindications, warnings, precautions
- Calibration instructions for specific isotopes
- Expected uncertainty for each radionuclide
- Activity range specifications
- Source positioning requirements
- Maintenance schedules
- Sources of error discussion
Safety
- Electromagnetic compatibility must be addressed
- Environmental factors limitations must be specified
- Power source specifications must be provided
Other considerations
- Design controls compliance for Special 510(k)
- Comparison to predicate device required
- Administrative documentation requirements
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
Related references and norms
- IEC 61303: Medical Electrical Equipment: Radionuclide calibrators – Particular methods for describing performance
- IEC 61145: Calibration and usage of ionization chamber systems for assay of radionuclides
- ANSI N42.13-1986: Calibration and usage of “dose Calibrator” ionization chambers for the assay of radionuclides
Original guidance
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