Testing and Performance Requirements for MR Receive-Only Coils for General Diagnostic Use
This guidance covers MR receive-only coils intended for hydrogen/proton imaging with no patient contact or limited contact with intact skin. The devices should be air-cooled and designed for general diagnostic use. The guidance excludes coils for specific clinical indications, new imaging agents, or endocavity coils.
Recommended Actions
- Conduct all required performance testing according to specified standards
- Obtain clinical image review from qualified physician
- Perform biocompatibility evaluation or provide rationale for exemption
- Prepare comprehensive test documentation including:
- Results summaries
- Declarations of Conformity
- Circuit diagrams
- Clinical image samples
- Biocompatibility documentation
- Consider Pre-Submission if additional testing beyond guidance scope is needed
- Ensure all temperature and safety limits are met
- Document decoupling mechanisms
- Prepare EMC and electrical safety testing documentation
Key Considerations
Clinical testing
- Sample clinical images must be reviewed by a US Board Certified or international equivalent qualified physician
- Images must be of diagnostic quality for all target anatomical locations
Non-clinical testing
- Image Signal to Noise (SNR) requirements: >130 for 1.5T coils, >215 for 3T coils
- Image Uniformity: Worst-case non-uniformity < 50%
- Surface heating: Temperature < 41°C for both normal use and single fault conditions
- Decoupling circuit must be present and documented
- EMC testing: pass at ±8 kV contact, ±2 kV, ±4 kV, ±8 kV, ± 15 kV air
- General electrical/mechanical safety testing required
Biocompatibility
- Required testing for surface devices with intact skin contact ≤24 hours:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
Safety
- Must comply with electrical safety standards
- Temperature limits must be maintained
- Decoupling mechanisms must be present
Other considerations
- Device must be air-cooled only
- Only receive-only RF coils are covered
Relevant Guidances
- Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms
- IEC 62464-1: Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
- NEMA MS 1: Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
- NEMA MS 6: Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils
- NEMA MS 9: Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- NEMA MS 14: Characterization of Radiofrequency (RF) Coil Heating
- IEC 60601-1-2: Medical electrical equipment – EMC requirements
- AAMI/ANSI ES60601-1: Medical electrical equipment - General Requirements for Basic Safety
- IEC 60601-2-33: Particular requirements for MR equipment safety
- ISO 10993-1: Biological evaluation of medical devices
Original guidance
- Testing and Performance Requirements for MR Receive-Only Coils for General Diagnostic Use
- HTML / PDF
- Issue date: 2020-12-11
- Last changed date: 2020-12-10
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, 510(k), Premarket, Radiology
- ReguVirta summary file ID: 2ebf4acf79a476930a33645939fe1b51
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