Guidance for Industry
Cardiac Monitor Guidance
(including Cardiotachometer and
Rate Alarm)
Document issued on: November 5, 1998
U.S. Department Of Health And Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Pacing Devices Branch
Division of Cardiovascular and Respiratory Devices
Office of Device Evaluation
Cardiac Monitor Guidance, Version 1.0 Page i Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to
James Cheng, Center for Devices and Radiological Health, 9200 Corporate Boulevard,
HFZ-450, Rockville, MD 20850.  Comments may not be acted upon by the Agency until
the document is next revised or updated.  For questions regarding the use or interpretation
of this guidance contact James Cheng, at 301-443-8517.
Additional Copies
World Wide Web/CDRH home page:  http://www.fda.gov/cdrh/ode/cmonitor.pdf, or
CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 2233when
prompted for the document shelf number.
Cardiac Monitor Guidance 1
CARDIAC MONITOR GUIDANCE
(INCLUDING CARDIOTACHOMETER
AND RATE ALARM)
TABLE OF CONTENTS
I.  Scope...................................................................................................................................1
II. Recommended Information and Testing................................................................................2
A. Device Description............................................................................................................2
B. Comparison to Predicate....................................................................................................2
C. Performance Testing..........................................................................................................3
1. Comparison Testing.......................................................................................................3
2. EC13 Standard Testing...................................................................................................4
3. Other Standards.............................................................................................................4
4. Suggested Format for Test Reports................................................................................4
D. In-Vitro Safety Testing......................................................................................................5
1. Environmental Testing....................................................................................................5
2. Software........................................................................................................................5
3. Electrical Safety.............................................................................................................5
4. Electromagnetic Compatibility........................................................................................6
E. Labeling............................................................................................................................7
F. Regulatory Requirements...................................................................................................7
G. References.........................................................................................................................7
                                               
1   This document is intended to provide guidance.  It represents the Agencys current thinking on the above.  It does not
create or confer any rights for or on any person and does not operate to bind FDA or the public.  An alternative approach
may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Cardiac Monitor Guidance CARDIAC MONITOR GUIDANCE
(INCLUDING CARDIOTACHOMETER
AND RATE ALARM)
Version 1.0
I. Scope
This guidance is intended to aid in the preparation or review of premarket notification (510(k))
applications for the devices regulated under:
CFR Section: 21 CFR 870.2300, Cardiac Monitor (including cardiotachometer and
rate alarm)
Class: II
Panel: Circulatory System Devices Panel (74)
Product Code: DRT
This guidance applies to most of the cardiac monitors covered by the ANSI/AAMI EC13-1992
standard for Cardiac Monitors, Heart Rate Meters, and Alarms (EC13 standard). Included in the
EC13 standard are ECG devices intended for monitoring purposes; diagnostic ECG devices are
addressed by EC11, and are discussed in further detail in the FDA guidance Diagnostic ECG
Devices.
Note that this guidance does not apply to the following cardiac monitors, which are classified
elsewhere, and excluded by the EC13 standard:
  devices for fetal heart rate monitoring
  pulse plethysomographic devices
  devices that use invasive catheters or sensors
  devices for monitoring ambulatory ECG
Sometimes, the cardiac monitor acts only as a signal acquisition device, and transmits via radio
frequency telemetry (or hardwire) the detected ECG waveforms to a central station for
processing.  If the processing at the central station is only for generating heart rate alarms, the
cardiac monitor remains in regulatory Class II (as 74 DRT/II). However, if the processing at the
central station involves real-time arrhythmia detection and alarms, the cardiac monitor and the
central station are both placed into Class III (as 74 DSI/III), and are not covered by this guidance
document.
NOTE:  This guidance does not address issues specific to central monitoring stations, networked
devices, or devices that use telemetry or transtelephonic communication.  Please contact the
Division for additional guidance on additional information that should be included in a submission
for these types of devices.
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 1 This guidance is complementary to the requirements of 21 CFR  807.87.  Other information not
identified in this guidance may be required in a 510(k) application.  This guidance is subordinate
to all other applicable statutes, regulations, and policies.
II. Recommended Information and Testing
A. Device Description
The description should include sufficient information to define the design, capabilities,
and function of the device, and the scope of the 510(k) submission.  Minimal
information includes:
1.  intended use (an explicit description of all clinical functions performed by the device,
e.g., measures heart rate and sounds an alarm when the heart rate falls outside of
preset limits, etc.),
 
2.  contraindications and indications for use (describe when and where the device is or is
not to be clinically used, and the intended patient population),
 
3.  photographs or drawings of the device with all accessories included in the
submission,
 
4.  functional block diagram, including all accessories,
 
5.  identification of all components and accessories included in the 510(k), and any
collateral devices which can be connected or used with the monitor (e.g., personal
computers (PCs), printers, database management software),
 
6.  material descriptions for all patient contacting materials,
 
7.  product specifications with ranges and/or accuracy (e.g., measurement limits,
operating limitations, power source specifications, available modes or settings, and
any other functional or physical limitation of the device),
 
8.  discussion of the functional performance characteristics of  the device, including any
new or unique features,
 
9.  an explanation of how the device interacts with the user, including whether the
device can be programmed and to what extent.
B. Comparison to Predicate
Identify the legally-marketed predicate device by name, manufacturer, and 510(k)
number (if available).   Provide a table that lists the similarities and differences between
your device and the predicate devices, and justify why any differences do not affect
safety and effectiveness.  The table should include the items listed above, with emphasis
on the following:
  indications for use, including patient population and intended use environment;
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 2  
  basic technological characteristics, such as the number of electrodes employed,
bandwidth, input dynamic range, storage of recorded signals, and analog or digital
technology;
 
  other technological features such as radio frequency telemetry, and transtelephonic
transmission (including FAX capabilities if applicable); and
 
  alarm management for both stand-alone devices and devices networked to a central
station.
If the 510(k) application is for a modification to an existing device, the manufacturer
should provide the specifications for the original device along with a detailed and
complete description of the similarities and differences between the two versions of the
device. 
C. Performance Testing
Substantial equivalence can be demonstrated by showing either 1) sufficient comparison
testing with a legally-marketed predicate device, 2) conformance to the EC13 standard,
or 3) conformance to any other standard which meets or exceeds the requirements of the
EC13 standard.  NOTE:  If the device incorporates significant new features,
additional testing may be necessary.  Please contact the Division for further
guidance.
1. Comparison Testing
It is recommended that substantial equivalence be demonstrated by showing
conformance to the EC13 standard.  However, if the manufacturer chooses to
provide comparative testing (i.e., to a predicate device), the provided data should
meet the Suggested Format for Test Reports (listed below) and account for the
following:
a)  The manufacturer should identify all of the safety and effectiveness issues for
their device.  These issues can be identified independently or in parallel with the
EC13 standard, i.e., a testing issue identified in the EC13 standard is usually
(but not always) relevant to the safety and effectiveness of a device.  The EC13
standard may not be sufficient, however, if the device incorporates a significant
new feature;
 
b)  There should be sufficient comparison testing provided to encompass each
safety and effectiveness issue related to the device.  Usually, a should be
conducted if it is capable of evaluating a failure mode, functional limitation, or
a labeling claim for the device;
 
c)  Provide sound scientific justification for the test methods and pass/fail criteria
that were used. Note that the test method  should evaluate the device in worst
case and normal operating conditions, and the pass/fail criteria should
demonstrate equal or better performance as compared to the predicate device.
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 3 2. EC13 Standard Testing
To show conformance to the EC13 standard, the manufacturer should list each of
the requirements of the standard and describe how the device conforms to each
requirement2   For every requirement which necessitates in-vitro testing, test data
and analysis should be provided and clearly identified (see the Data and Results
section of Suggested Format for Test Reports, below) .  If the test method
specified in the standard was not used or was modified, or if a section of the
standard is not applicable to the device, an appropriate justification should be
provided.  For devices with unique features or intended uses, additional testing
beyond the EC13 standard may be necessary.
If the EC13 standard is chosen by the manufacturer, conformance to the entire
standard should be demonstrated.  Conformance to portions of the standard is
usually insufficient to permit the standards use or to allow a labeling claim of
conformance to the standard.  Therefore, if only part of the standard is met, the
manufacturer should refer to the Comparison Testing section of this guidance.
3. Other Standards
If the manufacturer chooses to conform to a standard other than the EC13, it is
recommended that they list each requirement of the EC13 standard, compare the
other standard to the EC13 requirements, and clearly identify where the other
standard does not meet the requirements of the EC13 standard (if at all). 
Justification for any differences should be based on valid scientific or statistical
analyses and supported by testing if necessary.   Test reports should meet the
Suggested Format for Test Reports, as listed below.
4. Suggested Format for Test Reports
The test report should include the following elements, or a justification for their
omission:
a)  Test protocol, which minimally includes:
  the purpose of the test,
  a clear description (with schematics) of the test set-up and any device
modifications,
  the identification and precision of the equipment used,
  step-by-step descriptions of the data collection methods and device modes
used, and
  justification for the testing parameters (e.g., testing temperature, length of
test, the selection of device modes, etc.) and the pass/fail criteria.  The
testing parameters and pass/fail criteria should be conservative and based
on the extreme clinical use of the device, according to the intended use or
applicable standard.  Depending on the test, it may be appropriate to base
                                               
2   If EC 13 becomes a Recognized Standard, it will not be necessary to submit the test report.  Instead, a Declaration
of Conformity should be submitted (see the Guidance on the Recognition and Use of Consensus Standards).  Refer to
the CDRH Web page for the most recent list of Recognized Standards.
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 4 the testing parameters on the normal use of the device.  However, if an
extreme exists, it should be explored.
b)  Data and results, which minimally include:
  clearly labeled data with the appropriate units,
  the data should be easily associated with the methods described in the
protocol,
  for any graph, a table listing each data point shown on the graph is
necessary, and
  for any calculated values, the calculated values should be obvious and
calculated according to formulae presented in the protocol.
c)  Analysis, which minimally includes:
  an evaluation of the test data according to the pass/fail criteria and purpose
defined in the test protocol,
  identification of the inadequacies and accuracy of the test,
  evaluation of the need for additional testing, and a clear conclusion which
is within the scope of the particular test.
D.   In-Vitro Safety Testing
1. Environmental Testing
The manufacturer should evaluate the ability of the device to function after exposure
to the environmental hazards expected when used by an abusive user.  Tests for
some of these hazards  may be found in EC13, IEC 601-1, UL 2601, IEC 68-2, and
IEC 529. 
If a device is intended to be used outside of the hospital environment (e.g., those
indicated for use in a transport environment such as an ambulance or helicopter), it
may require additional testing. For example, cardiac monitors intended for use in an
ambulance should generally meet an appropriate shock/vibration test (e.g., see the
IEC 68-2 series), and should demonstrate immunity to a field strength of 20 V/m
(rather than the 3 V/m typically needed).  Additional testing is necessary for use in
helicopters and aircraft  contact the Division for guidance.
2. Software
Depending on the proposed indications for use, cardiac monitors may be considered
to have a level of concern ranging from minor to moderate. Refer to the Guidance
for the Content of Premarket Submissions for Software Contained in Medical
Devices for additional information about software documentation for a 510(k).
3. Electrical Safety
Any appropriate standard for electrical safety (e.g., ANSI/AAMI ES-1, IEC 601-1)
may be used.  If the EC13 standard is used, the manufacturer should conform to the
standards requirements or justify any deviation from the standard.
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 5 4. Electromagnetic Compatibility
Electromagnetic compatibility (EMC) testing should be done to demonstrate that
the device will not adversely interfere with the performance of other electronic
devices (emissions), and will perform as expected in the presence of other electronic
devices or other sources of electromagnetic interference (EMI) in the intended
environment of use (immunity). 
NOTE:  If the device is intended for use outside the hospital environment,
additional testing may be necessary.  See Environmental Testing, above, for details.
To demonstrate EMC for the device, one of the following options may be chosen:
a)  Provide test data demonstrating conformance to part 3.2.10 (Electromagnetic
Compatibility) of ANSI/AAMI EC38-1994 (Ambulatory Electrocardiographs). 
List each requirement of the standard and describe how the device conforms to
it.  For every requirement which necessitates in-vitro testing, test data and
analysis should be provided and clearly identified (see the Data and Results
section of Suggested Format for Test Reports, above) .  If the test method
specified in the standard was not used or was modified, or if a section of the
standard is not applicable to the device, an appropriate justification should be
provided.
 
b)  Provide a Declaration of Conformity to IEC 601-1-2 (refer to Guidance for the
Recognition and Use of Consensus Standards for additional details on how to
prepare a declaration of conformity); or
 
c)  Provide the following information:
  Identification of every intended environment in which the device will be
used, e.g., hospital general ward, hospital ICU/CCU, clinic, vehicle/traffic
areas, emergency vehicle (including aircraft), operating room, home.  This
description should identify the possible sources of EMI which could affect
the device.
 
  Identification of the selected standard, justification for its use, and test
reports which conform to the Suggested Format for Test Reports. 
Testing should be applicable to the intended environments described above
and should address the following as appropriate for the device:
(cid:216)  Emissions: radiated and conducted electromagnetic fields, and
(cid:216)  Immunity: radiated electromagnetic fields, electrostatic discharge,
electrical fast transients/bursts, ands surges.
Any omitted tests or deviations from the requirements of the chosen standard
should be accompanied by appropriate justification.
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 6 E. Labeling
Conformance to the labeling regulations and policies is necessary (see 21 CFR
807.87(e)).  Appropriate labeling guidances are available through the Division of Small
Manufacturers Assistance (DSMA) at its toll-free number (800) 638-2041 or at its
internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html.
If the EC13 standard is used, the labeling requirements of the standard should be
included or justification provided for any modifications.
F. Regulatory Requirements
Either a Summary of Safety and Effectiveness or a 510(k) Statement is necessary as
described in  21 CFR  807.92 and 21 CFR  807.93, respectively.
A Truthful and Accuracy Statement is necessary according to 21 CFR 807.87 (j).
An Indications for Use Statement is necessary according to Office of Device
Evaluation policy.  A format for this statement can be provided to the manufacturer by
DSMA.
G. References
ANSI/AAMI EC13-1992, Cardiac monitors, heart rate meters, and alarms
ANSI/AAMI EC38-1994, Ambulatory electrocardiographs
ANSI/AAMI ES1-1993, Safe current limits for electromedical apparatus
IEC 60601-1-2 (1993), Medical Electrical Equipment- Part 1: General Requirements
for Safety; 2. Collateral Standard: Electromagnetic Compatibility- Requirements and
Tests.
IEC 68-2-6 1982) with Amendment 1-1983 and Amendment 2-1985:  Basic
Environmental Testing Procedures part 2: Tests. Test Fc and Guidance: Vibration
(Sinusoidal).
IEC 68-2-6 1982) with Amendment 1-1983 and Amendment 2-1985:  Basic
Environmental Testing Procedures part 2: Tests. Test Ea and Guidance: Shock.
IEC 68-2-6 1982) with Amendment 1-1983 and Amendment 2-1985:  Basic
Environmental Testing Procedures part 2: Tests. Test Fdc and Guidance: Random
Vibration Wide Band  Reproducibility Low.
IEC 529 (1989): Classification of Degrees of Protection Provided by Enclosures.
FDA, guidance entitled, (Draft) Guidance for the Content of 510(k) Submissions for
Electrocardiographs, ### date.
FDA, guidance entitled, Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices, May 29, 1998
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 7 FDA, Blue Book memorandum #K97-1 entitled, Deciding When to Submit a 510(k)
for a Change to an Existing Device.
FDA, Premarket Notification 510(k), Regulatory Requirements for Medical Devices,
FDA 95-4158.
FDA, guidance entitled, Reviewer Guidance for Premarket Notification Submissions,
November 1993.
FDA, guidance entitled, The New 510(k) Paradigm: Alternate Approaches to
Demonstrating Substantial Equivalence in Premarket Notifications, March 20, 1998.
FDA, guidance entitled, Guidance on the Recognition and Use of Consensus
Standards, February 19, 1998.
Acknowledgements:
The following people contributed to the development of this guidance document:
Charles Ho
Jim Cheng
Jennifer Goode
Frank Lacy
Donna-Bea Tillman
 Based on a template by Sandy Stewart.
Cardiac Monitor Guidance, Version 1.0 (November 2, 1998) Page 8