| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 08/06/2013
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FR Recognition Number
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13-56
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| Standard | |
IEEE Std 11073-10406-2011
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
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Identical AdoptionISO IEEE 11073-10406 First edition 2012-12-01
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
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Scope/Abstract| Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes)in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE Std 11073-20601 information models. Itspecifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core ofcommunication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support forwearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiacphenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate). |
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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 IEEE Std 11073-10406-2011 [Rec# 13-56] will be superseded by recognition of IEEE Std 11073-10406-2023 [Rec# 13-147]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-56] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 13-56] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.2300 |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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Class 2
|
DRT
|
| §870.2300 |
System, Network And Communication, Physiological Monitors
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Class 2
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MSX
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| §870.2300 |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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Class 2
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MWI
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| §870.2340 |
Electrocardiograph
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Class 2
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DPS
|
| §870.2340 |
Monitor, St Segment
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Class 2
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MLC
|
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement), November 5, 1998
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. |
