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.
Recommended Actions
- Conduct comprehensive risk assessment considering pediatric-specific hazards and mitigations
- 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
- Develop comprehensive labeling including:
- Pediatric summary section
- Clear warnings and precautions
- Description of pediatric features
- Protocol summaries with dose information
- Perform laboratory testing across full range of patient sizes:
- Image quality assessment
- Dose assessment
- Performance verification of pediatric features
- Create training program emphasizing:
- Optimal use of dose reduction features
- Pediatric-specific considerations
- Quality control procedures
- 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
- 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
- Consideration of pediatric subgroups based on patient size
- Balance between image quality and radiation dose
- Consultation with pediatric imaging specialists during design
- Provision of additional educational materials on pediatric imaging
Relevant Guidances
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
Related references and norms
- 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
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