Content Considerations for 510k Submissions of Emission Computed Tomography and Nuclear Tomography Systems

Recommended Actions

1. Determine submission type (Special, Abbreviated or Traditional 510(k))
2. Prepare device documentation:
   • Complete device description with specifications
   • Performance testing data according to NEMA standards
   • Software documentation
   • Safety testing results
   • Clinical images
   • Labeling materials
3. Prepare administrative documentation:
   • 510(k) Summary/Statement
   • Indications for Use form
   • Truthful and Accurate Statement
   • Declarations of Conformity (if applicable)
4. Conduct comparison with predicate devices:
   • Identify suitable predicates
   • Document similarities and differences
   • Provide rationale for substantial equivalence
5. Implement quality control and maintenance procedures:
   • Develop QC protocols
   • Define maintenance schedules
   • Document radioisotope handling procedures
6. Ensure compliance with safety requirements:
   • Electrical/mechanical safety standards
   • Radiation safety limits
   • Risk management procedures

Key Considerations

Clinical testing

• Submit sample images from three clinical cases for SPECT, PET and CID systems
• For UHEC: Submit sample images from three different organs (brain, lung, heart)
• For ACD: Submit images from three clinical studies with and without ACD

Non-clinical testing

• Performance testing according to NEMA standards (NU1 for SPECT, NU2 for PET) including:
  • Spatial resolution
  • Energy resolution
  • Spatial linearity
  • Flood field uniformity
  • Count rate sensitivity
  • Background isolation
• For ACD: Radiation measurements and phantom testing with/without ACD
• For UHEC: Mechanical safety testing of collimator mounting

Software

• Moderate level of concern software documentation required including:
  • Software description and version
  • Hazard analysis
  • Requirements specifications
  • Architecture design
  • Traceability analysis
  • Validation and verification testing
  • Revision history
  • List of remaining bugs/errors

Labelling

• Essential Prescribing Information including:
  • Device description
  • Intended use/indications
  • Contraindications, warnings, precautions
  • Quality control methods
  • Maintenance schedules
  • NRC requirements for radioisotope handling
• Summary specification sheet
• Promotional materials
• User manual
• For UHEC: Additional precautionary statements on spatial resolution
• For ACD: Source replacement procedure

Safety

• Electrical and mechanical safety testing per recognized standards
• For ACD and transmission sources:
  • Leakage radiation measurements (<2 mGy/h at 5cm, <20 μGy/h at 1m)
  • Patient radiation dose estimates
• Hazard analysis for all potential risks

Other considerations

• Year 2000 compliance (until January 1, 2000)
• Comparison to predicate devices
• Administrative documentation (510(k) summary, indications for use form, etc.)

  Relevant Guidances

• Content of Premarket Submissions for Device Software Functions
• Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
• Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices

Related references and norms

• NEMA NU 1: Performance Measurements of Scintillation Cameras (1994)
• NEMA NU 2: Performance Measurements of Positron Emission Tomographs (1994)
• IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety
• IEC 60601-1-2: Requirements for safety; Electromagnetic Compatibility
• EN 1441 (1997): Medical Devices – Risk Analysis
• UL 544: Standards for Medical, Dental Equipment, 3rd edition
• UL 2601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety
• NEMA PS3: DICOM (Digital Imaging and Communications in Medicine)

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Original guidance

• Content Considerations for 510k Submissions of Emission Computed Tomography and Nuclear Tomography Systems
• HTML / PDF
• Issue date: 1998-12-02
• Last changed date: 2023-12-13
• Status: FINAL
• Official FDA topics: Medical Devices, Radiology, Premarket
• ReguVirta summary file ID: 2c3144cbe62407e9685357a9ddec585f