Post

Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations

This guidance applies to x-ray imaging devices specifically indicated for pediatric use or general use x-ray imaging devices where considerable pediatric application is anticipated. It covers both new devices and modifications requiring new 510(k) submissions, including complete systems, components, and accessories.

  1. Conduct comprehensive risk assessment considering pediatric-specific hazards and mitigations
  2. Implement appropriate pediatric design features based on risk assessment:
    • Automatic exposure control for pediatric patients
    • Pediatric protocols and control settings
    • Dose optimization features
    • User interface guidance for pediatric imaging
  3. Develop comprehensive labeling including:
    • Pediatric summary section
    • Clear warnings and precautions
    • Description of pediatric features
    • Protocol summaries with dose information
  4. Perform laboratory testing across full range of patient sizes:
    • Image quality assessment
    • Dose assessment
    • Performance verification of pediatric features
  5. Create training program emphasizing:
    • Optimal use of dose reduction features
    • Pediatric-specific considerations
    • Quality control procedures
  6. Prepare 510(k) submission including:
    • Clear indications for use regarding pediatric populations
    • Complete risk assessment documentation
    • Test results demonstrating performance across patient sizes
    • Labeling and training materials
  7. Consider pre-submission meeting if clinical images of pediatric patients may be needed

Key Considerations

Clinical testing

  • Clinical images of pediatric patients only requested when laboratory testing is insufficient
  • Images should include dose information, exposure settings, and clinical information if available
  • Pre-submission meeting recommended to discuss need for pediatric clinical images

Non-clinical testing

  • Performance assessment across entire range of patient sizes (neonate through adult)
  • Testing with representative path lengths and phantoms
  • Assessment of image quality and radiation dose
  • Testing of automatic exposure control (AEC) performance
  • Evaluation of sensitometric response, MTF, noise, DQE
  • Testing for image artifacts and ghosting

Human Factors

  • Training program emphasizing optimal use of dose reduction features
  • Accessible and practical training targeted at different end users
  • Testing questions addressing pediatric use understanding

Software

  • Pediatric protocols and control settings
  • Software interface features guiding users on pediatric issues
  • Dose information display and recording capabilities

Labeling

  • Pediatric summary section in instructions for use
  • Clear contraindications, warnings and precautions for pediatric use
  • Description of pediatric-specific features and options
  • Instructions for pediatric device configuration
  • Quality control testing recommendations
  • Protocol summaries with dose information
  • Training materials emphasizing pediatric safety

Safety

  • Risk assessment considering pediatric-specific hazards
  • Mitigation strategies for pediatric radiation exposure
  • Features enabling dose optimization for pediatric patients
  • Safety features preventing exposure outside anatomy of interest

Other considerations

  • IEC 60601-2-44: Medical electrical equipment - Part 2-44: Particular requirements for basic safety and essential performance of X-ray equipment for computed tomography
  • IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • IEC 60601-2-43: Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
  • IEC 62220-1-1: Medical electrical equipment - Characteristics of digital x-ray imaging devices - Part 1: Determination of detective quantum efficiency
  • IEC 62494-1: Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
  • IEC 62985: Methods for calculating Size Specific Dose Estimate (SSDE) on Computed Tomography

Original guidance

  • Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
  • HTML / PDF
  • Issue date: 2017-11-28
  • Last changed date: 2024-04-08
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Medical Devices, Pediatric Product Development, 510(k), Premarket, Radiology
  • ReguVirta summary file ID: 127bb332c0bd13516a18683f4eff89b6
This post is licensed under CC BY 4.0 by the author.