| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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13-146
|
| Standard | |
IEEE 11073-10103 Second edition 2023
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
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Scope/Abstract| The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system. |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ISO IEEE 11073-10103 First edition 2014-03-01 [Rec# 13-84] will be superseded by recognition of IEEE 11073-10103 Second edition 2023 [Rec# 13-146]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-84] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 13-84] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.3610 |
Pacemaker Battery
|
Class 3
|
DSZ
|
| §870.3610 |
Implantable Pacemaker Pulse-Generator
|
Class 3
|
DXY
|
| §870.3610 |
Leadless Pacemaker
|
Class 3
|
PNJ
|
| §870.3680 |
Permanent Pacemaker Electrode
|
Class 3
|
DTB
|
| §870.5300 |
Atrial Defibrillator
|
Class 3
|
MPC
|
| §870.5310 |
Automated External Defibrillators (Non-Wearable)
|
Class 3
|
MKJ
|
| 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 |
Pulse Generator, Permanent, Implantable
|
Class 3
|
NVZ
|
| N/A |
Implantable Pulse Generator
|
Class 3
|
QFV
|
|
Relevant FDA Guidance and/or Supportive Publications*
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued 2023.
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff: issued August 2023.
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, Document Issued on October 28, 2003.
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; A Rule by the Food and Drug Administration on 02/03/2015
ANSI AAMI IEC 60601-2-4:2010/A1:2018Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment
ISO 14708-2 Third edition 2019-09 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
ISO 14708-6 Second edition 2019-09 Implants for surgery - Active implantable medical devices - Part 6: Particular
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 Contacts
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| Standards Development Organization
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FDA Specialty Task Groups (STG)
| Software/Informatics (primary) |
| Cardiovascular |
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| *These are provided as examples and others may be applicable. |
