| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
|
Date of Entry 05/29/2023
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|
FR Recognition Number
|
3-185
|
| Standard | |
ANSI AAMI PC76:2021
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |
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Scope/Abstract| Provides requirements and test protocols for implantable pacemakers and ICDs exposed to magnetic resonance imaging. Physicians are increasingly using magnetic resonance imaging as tool for differential diagnostic, thus exposing pacemakers and ICD patients to such equipment. Current product standards for implantable pacemakers and ICDs do not include requirements and test protocols for implantable pacemakers and ICDs, which would ensure patient safety during such procedures. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
- Clause 6 Global malfunction:
-- The sentence on page 6, "This step [Step 2, Functional Verification right after exposure] only applies to MR combined fields and B0 malfunction tests."
-- Table 2, "Injected Tests" column for Step 2: Functional Verification right after exposure
- Clauses 8.6.1, 8.8.1, 9.3, and Annex C - CEM43 acceptance criteria
- Clauses 9.2.2 and 9.2.3 - use of 90th percentile RMS power levels and 90th percentile E-field values
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Note: Functional verification tests and selected percentiles may vary with intended use and risk-based assessment. We encourage you to contact the review division prior to initiating your testing.
This standard is recognized in part because:
- The parts of Clause 6 identified above are in conflict with an existing published final guidance, see Section V.G. of the guidance listed below (ref #1).
- The CEM43 acceptance criteria in Clauses 8.6.1, 8.8.1, 9.3, and Annex C are in conflict with an existing published final guidance, see Section V.C. of the guidance listed below (ref #1).
- The use of 90th percentile RMS power levels and 90th percentile E-field values in Clauses 9.2.2 and 9.2.3 are in conflict with an existing published final guidance, see Section V.C. of the guidance listed below (ref #1). |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.3610 |
Implantable Pacemaker Pulse-Generator
|
Class 3
|
DXY
|
| §870.3610 |
Leadless Pacemaker
|
Class 3
|
PNJ
|
| §870.3620 |
Pacemaker Lead Adaptor
|
Class 2
|
DTD
|
| §870.3680 |
Permanent Pacemaker Electrode
|
Class 3
|
DTB
|
| §870.3680 |
Electrode, Pacemaker, Temporary
|
Class 2
|
LDF
|
| §870.3680 |
Electrode, Pacing And Cardioversion, Temporary, Epicardial
|
Class 2
|
NHW
|
| §870.3710 |
Materials, Repair Or Replacement, Pacemaker
|
Class 3
|
KFJ
|
| N/A |
Implantable Pulse Generator, Pacemaker (Non-Crt)
|
Class 3
|
LWP
|
| N/A |
Implantable Cardioverter Defibrillator (Non-Crt)
|
Class 3
|
LWS
|
| N/A |
Defibrillator, Implantable, Dual-Chamber
|
Class 3
|
MRM
|
| N/A |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
|
Class 3
|
NIK
|
| N/A |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
|
Class 3
|
NKE
|
| N/A |
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
|
Class 3
|
NVN
|
| N/A |
Permanent Defibrillator Electrodes
|
Class 3
|
NVY
|
| N/A |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
|
Class 3
|
OJX
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff, issued May 2021.
2. ISO/TS 10974 Second edition 2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
