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

What You Need to Know? 👇

What are the key differences between Special 510(k) and Abbreviated 510(k) submissions for medical devices?

Special 510(k) applies to device modifications where design controls demonstrate substantial equivalence, processed within 30 days. Abbreviated 510(k) uses conformance to FDA-recognized voluntary standards instead of data review, eliminating need for experimental data when standards cover device aspects.

Which NEMA standards are recognized by FDA for emission computed tomography devices?

FDA recognizes NEMA NU 1 (Performance Measurements of Scintillation Cameras, 1994) for SPECT devices and NEMA NU 2 (Performance Measurements of Positron Emission Tomographs, 1994) for PET devices. These provide standardized measurement methods but don’t specify performance limits.

What software documentation is required for ECT devices in 510(k) submissions?

ECT device software requires moderate-level documentation including: software description with version number, hazard analysis, requirements specifications, architecture design chart, validation/verification activities, system-level test protocols with results, and revision history with remaining bugs explanation.

What performance characteristics must be provided for SPECT system 510(k) submissions?

SPECT systems must provide: intrinsic spatial resolution (FWHM at surface and 10cm), spatial energy resolution, spatial linearity, flood field uniformity, count rate sensitivity, and detector isolation from background. Testing should use NEMA NU1 phantom or equivalent.

What are the radiation safety requirements for transmission sources in PET/SPECT attenuation correction devices?

Leakage rates must be less than 2 mGy/h (200 mrad/h) at 5cm from source housing surface and less than 20 µGy/h (2 mrad/h) at 1m from source. Patient radiation exposure estimates for typical procedures must be provided.

What clinical evidence is required for emission computed tomography device 510(k) submissions?

Clinical images from three different cases (SPECT), three different organs like brain/lung/heart (511 keV collimators), or three clinical studies with/without attenuation correction (ACD) must be submitted. Images should demonstrate device performance in clinical settings.

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What You Need to Do 👇

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.)

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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 ID: 2c3144cbe62407e9685357a9ddec585f