Contains Nonbinding Recommendations 
Magnetic Resonance (MR) Receive-
only Coil  Performance Criteria for 
Safety and Performance Based 
Pathway 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on December 11, 2020. 
The draft of this document was issued on December 9, 2019. 
For questions about this document, contact Division of Radiological Health at 301-796-6641. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2019-D-1650. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
19011 and complete title of the guidance in the request.  Contains Nonbinding Recommendations 
Magnetic Resonance (MR) Receive-
only Coil  Performance Criteria for 
Safety and Performance Based 
Pathway 
Guidance for Industry and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I.  Introduction 
This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in 
support of the Safety and Performance Based Pathway.1 Under this framework, submitters (you) 
planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-
only coils will have the option to use the performance criteria proposed in this guidance to 
support substantial equivalence, rather than a direct comparison of the performance of the subject 
device to that of a predicate device. 
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.2 For more information 
regarding use of consensus standards in regulatory submissions, please refer to the FDA 
guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices.3  
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
                                                
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway 
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
1  Contains Nonbinding Recommendations 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. 
  
II.  Scope/Device Description 
The MR receive-only coils that are the subject of this guidance are intended to produce images of 
human anatomy for general diagnostic use by trained clinicians. These MR receive-only coils are 
Class II and are regulated under 21 CFR 892.1000 Magnetic resonance diagnostic device, with 
the product code MOS (Coil, Magnetic Resonance, Specialty). 
Intended Use/Indications for Use: 
The MR receive-only coils that fall within the scope of this guidance document are intended for 
hydrogen/proton imaging. These devices are intended to have no patient contact or intended only 
for limited contact with intact skin (i.e., no endocavity coils). MR coils intended for specific 
clinical indications (for example, disease identification or rule-out, diagnosis or prognosis with 
respect to disease staging or severity, and prevention or reduction in morbidity and/or mortality 
associated with particular diseases) or intended for new imaging agent uses are outside the scope 
of this guidance document. 
Device Design Characteristics: 
The MR coils that fall within the scope of this guidance document are designed to be air-cooled 
(i.e., no water-cooled or cryogen-cooled electronics). In addition, only receive-only 
radiofrequency (RF) coils are within the scope of this guidance. 
General guidance that is beyond the scope of this safety and performance guidance document 
regarding submission of a 510(k) for MR coils (i.e., labeling), can be found in FDAs guidance 
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.4
FDA may determine, on a case-by-case basis, that additional data are necessary to evaluate 
whether the device is appropriate for the Safety and Performance Based Pathway. In situations 
where you determine that additional testing outside of those identified in this guidance are 
necessary to determine whether the device is appropriate for the Safety and Performance Based 
Pathway, we encourage you to submit a Pre-Submission5 to engage in discussion with FDA prior 
to submission of the 510(k). 
III.  Testing Performance Criteria 
If your device is appropriate for submission through the Safety and Performance Based Pathway, 
and you choose to use that option, you do not need to provide direct comparison testing against a 
legally marketed predicate device to demonstrate substantially equivalent performance 
characteristics. To ensure that the performance criteria outlined in this guidance remain 
                                                
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-premarket-
notifications-magnetic-resonance-diagnostic-devices 
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
2 Contains Nonbinding Recommendations 
contemporary and take into account relevant data from recent clearances, FDA recommends that 
you provide a results summary for all tests evaluated in addition to the other submission 
information (e.g., Declaration of Conformity (DoC)) identified for each test or evaluation below. 
Unless otherwise identified in the submission information sections below, test information such 
as results summary, test protocols (including MR system information), or complete test reports 
should be submitted as part of the 510(k) as described in FDAs guidance Safety and 
Performance Based Pathway.6 For additional information regarding the submission of non-
clinical bench testing information, please see FDAs guidance Recommended Content and 
Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.7
1.  Test name: Image Signal to Noise (SNR) 
Methodology: Conformance to one of the following FDA recognized consensus 
standards (as applicable): 
  IEC 62464-1  Magnetic resonance equipment for medical imaging - Part 1: 
Determination of essential image quality parameters 
  National Electrical Manufacturers Association (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 in Diagnostic Magnetic Resonance Imaging 
(MRI) 
  NEMA MS 9 Characterization of Phased Array Coils for Diagnostic Magnetic 
Resonance Images (MRI) 
Performance Criteria: >130 (for 1.5T coils), >215 (for 3T coils) (using the lowest SNR 
measure over all imaging coils, planes, and anatomical regions) 
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA 
in 510(k) submissions for MR coils previously found to be substantially equivalent. 
Submission Information: Results summary and Declaration of Conformity (DoC) 
2.  Test name: Image Uniformity 
Methodology: Conformance to one of the following FDA recognized consensus 
standards (as applicable): 
  IEC 62464-1  Magnetic resonance equipment for medical imaging - Part 1: 
Determination of essential image quality parameters 
  NEMA MS 3 Determination of Image Uniformity in Diagnostic Magnetic 
Resonance Images 
  NEMA MS 6 Determination of Signal-to-Noise Ratio and Image Uniformity for 
Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging 
(MRI) 
  NEMA MS 9 Characterization of Phased Array Coils for Diagnostic Magnetic 
Resonance Images (MRI) 
Performance Criteria: Worst-case non-uniformity < 50% (e.g., without any optional 
software correction algorithms applied) 
                                                
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway 
7 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket 
3 Contains Nonbinding Recommendations 
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA 
in 510(k) submissions for MR coils previously found to be substantially equivalent. 
Additional Considerations: The gray-scale uniformity map methods described in 
NEMA MS 3 section 2.3.3 Gray-Scale Uniformity Map, NEMA MS 6 section 2.6 
Primary Measurement Procedure for Image Uniformity, NEMA MS 9 (which refer to the 
previously mentioned sections of NEMA MS 3 and NEMA MS 6), and Alternative 
method grey-scale map in section A.2.2 in IEC 62464-1 (Edition 2.0 2018-12) are 
excluded because these methods do not provide results that lend to simple objective 
assessment and performance criteria. 
Submission Information: Results summary and DoC 
3. Test name: Surface heating
Methodology: Conformance to the following FDA recognized consensus standard:
 NEMA MS 14 Characterization of Radiofrequency (RF) Coil Heating in 
Magnetic Resonance Imaging Systems 
Performance Criteria: Temperature criteria as defined by ANSI/AAMI ES 60601-1: 
<41C for both normal use and single fault (coil not plugged in) condition. 
Performance Criteria Source: FDA currently recognized version of ANSI/AAMI 
ES60601-1 (2012) Medical electrical equipment  Part 1: General requirements for 
basic safety and essential performance, Section 11.1.2 Temperature of Applied Parts 
Submission Information: Results summary and DoC 
4. Test name: Acquired Image Quality
Methodology: Sample clinical images from all target anatomical locations reviewed to
determine images produced by the device are of sufficient quality for diagnostic use.
Performance Criteria: Statement from a US Board Certified or international equilavent
qualified physician (e.g., radiologist, radiation oncologist) that images are of diagnostic
quality and sample clinical images to support the ability of your coil to generate
diagnostic quality images.
Performance Criteria Source:  FDA guidance document Submission of Premarket
Notifications for Magnetic Resonance Diagnostic Devices8
Additional Considerations: Due to the subjective nature of this assessment, you should
provide a small, representative subset of clinical images. Additionally, the review of
these sample clinical images will serve as an indirect assessment of the interoperability of
the coil with an MR system.
Submission Information: Statement from US Board Certified or international equilavent
qualified physician (e.g., radiologist, radiation oncologist) including a description of the
sequences and anatomical regions reviewed by the radiologist and small, representative
subset of clinical images including description of the target anatomical site, scan
parameters employed, and the total imaging time for each image.
5. Test name: Decoupling circuit
Methodology: Inspection of circuit diagrams
Performance Criteria: Presence of decoupling mechanisms
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-premarket-
notifications-magnetic-resonance-diagnostic-devices 
4 Contains Nonbinding Recommendations 
Performance Criteria Source: FDA guidance document Submission of Premarket 
Notifications for Magnetic Resonance Diagnostic Devices 
Submission Information: Circuit diagrams and description of decoupling mechanism 
6.  Test name: EMC  Immunity, electrostatic discharge 
Methodology: FDA currently recognized version of IEC 60601-1-2 Medical electrical 
equipment  Part 1-2: General requirements for basic safety and essential performance  
Collateral Standard: Electromagnetic disturbances  Requirements and tests 
Performance Criteria: pass at 8 kV contact, 2 kV, 4 kV, 8 kV, 15 kV air 
Performance Criteria Source: Current version of FDA recognized consensus standard 
IEC 61000-4-2: Electromagnetic compatibility (EMC)  Part 4-2: Testing and 
measurement techniques 
Additional Considerations: Due to options within the standard, DoC should identify 
options chosen 
Submission Information: Results summary and DoC 
7.  Test name: General electrical/mechanical safety 
Methodology: Current version of FDA consensus standards AAMI/ANSI ES60601-1 
Medical electrical equipment - Part 1: General Requirements for Basic Safety and 
Essential Performance and IEC 60601-2-33 Medical electrical equipment - Part 2-33: 
Particular requirements for the basic safety and essential performance of magnetic 
resonance equipment for medical diagnosis 
Performance Criteria: Demonstration that the device performs safely and as anticipated 
in its intended use environment 
Performance Criteria Source: FDA currently recognized version of AAMI/ANSI 
ES60601-1: Medical electrical equipment - Part 1: General Requirements for Basic 
Safety and Essential Performance and IEC 60601-2-33: Medical electrical equipment - 
Part 2-33: Particular requirements for the basic safety and essential performance of 
magnetic resonance equipment for medical diagnosis 
Additional Considerations: Due to options within the standard, DoC should identify 
options chosen. Coils with detachable parts should be considered in the context of patient 
setup (e.g., split-top design coils) for electrical/mechanical safety. 
Submission Information: Results summary and DoC 
Biocompatibility Evaluation: 
To identify the biocompatibility endpoints to include as part of your biocompatibility evaluation 
you should use Attachment A of the Center for Devices and Radiological Healths (CDRH) 
guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices  
Part 1: Evaluation and testing within a risk management process,9 referred to in the rest of this 
document as the CDRH Biocompatibility Guidance for brevity. FDA considers the devices 
covered by this guidance to be categorized as Surface Devices with intact skin and contact 
duration of  24 hours, and you should assess the endpoints below per Attachment A of the 
CDRH Biocompatibility Guidance. 
                                                
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-
standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and 
5 Contains Nonbinding Recommendations 
  Cytotoxicity 
  Sensitization 
  Irritation or Intracutaneous Reactivity 
Rationale in Lieu of Testing: If the subject device is manufactured from the identical raw 
materials using identical manufacturing processes as a predicate device with the same type and 
duration of tissue contact, and any changes in geometry are not expected to impact the biological 
response, this is typically sufficient to establish substantially equivalent biocompatibility, if 
documentation such as that outlined in Attachment F of the CDRH Biocompatibility Guidance is 
also provided. 
Testing: If you determined that testing is needed to address some or all of the identified 
biocompatibility endpoints, FDA recommends that complete test reports be provided for all tests 
performed unless a declaration of conformity without supplemental information can be 
appropriately provided, per Attachment E of the CDRH Biocompatibility Guidance. Any test-
specific positive, negative, and/or reagent controls should perform as expected, and protocol 
deviations should be thoroughly described and justified; however, note that certain protocol 
deviations may invalidate comparison to the performance criteria listed below and require 
submission of a Traditional, Special, or Abbreviated 510(k). 
8.  Test name: Biocompatibility endpoints (identified from CDRH Biocompatibility 
Guidance) 
Methodology: FDA currently-recognized versions of biocompatibility consensus 
standards 
Performance Criteria: All direct or indirect tissue contacting components of the device 
and device-specific instruments should be determined to have an acceptable biological 
response. 
Performance Criteria Source: The CDRH Biocompatibility Guidance 
Additional Considerations: For any biocompatibility test samples with an adverse 
biological response, the biocompatibility evaluation should explain why the level of 
toxicity seen is acceptable. Some comparison testing against a legally marketed predicate 
may be necessary (and is considered acceptable under the Safety and Performance Based 
Pathway) to support such a rationale as explained in the CDRH Biocompatibility 
Guidance. For standard biocompatibility test methods that include comparison device 
control samples, the legally marketed comparison device control samples should perform 
as expected, as specified above for the subject device samples.   
Submission Information: Refer to CDRH Biocompatibility Guidance 
6