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.
What You Need to Know? 👇
What are the three types of 510(k) submissions available for radionuclide dose calibrators?
The three types are: Traditional 510(k), Special 510(k) for device modifications (processed within 30 days), and Abbreviated 510(k) based on conformance to recognized voluntary standards. Each has different requirements and processing timelines.
Which consensus standards apply to radionuclide dose calibrators for FDA submissions?
Currently, no consensus standards for RDCs are recognized by CDRH. However, relevant standards include IEC 61303 for performance characteristics, IEC 61145 for ionization chamber calibration, and ANSI N42.13-1986 for dose calibrator usage.
What software documentation is required for RDCs with digital components?
Submissions must follow the “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” from May 1998. Additionally, devices must indicate Year 2000 compatibility and describe how this was determined.
What predicate device information must be included in an RDC 510(k) submission?
Required information includes manufacturer name, trade name, 510(k) number, similarities/differences description, promotional materials, and tabular comparison of specifications including detector type, activity ranges, accuracy, linearity, and measurement errors.
What calibration information must be provided for radionuclide dose calibrators?
Submissions must describe initial calibration methods, NIST-traceable calibration sources and their strengths, common error sources and magnitudes, plus calibration procedures for specific isotopes and new isotopes not available at manufacture.
What labeling requirements apply to radionuclide dose calibrator instructions for use?
Instructions must include indications for use, contraindications/warnings, calibration procedures for specific isotopes, expected uncertainty values, activity ranges, positioning requirements, software functions, maintenance schedules, and NRC compliance references.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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