(210 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The analysis software is described in general terms without indicating advanced algorithmic approaches.
No
Explanation: The device is intended to record, analyze, display, edit, and generate reports of ambulatory ECG for diagnostic purposes, not for direct treatment or therapy. The analysis results are explicitly stated to be "offered to doctors on an advisory basis only," further indicating its role as a diagnostic tool rather than a therapeutic one.
Yes
The device is intended to record, analyze, display, and generate reports of ambulatory ECG data for evaluating symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, drug response, and patients with pacemakers, all of which are aspects of diagnosing cardiac conditions. The analysis results are offered to doctors on an advisory basis.
No
The device description explicitly states the system is composed of both a "Holter recorder and Holter software," and the recorder is described as a physical device with lead wires and an SD card.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of donations with potential recipients, or to monitor therapeutic measures.
- Device Function: The SE-2003/SE-2012 Holter System records, analyzes, displays, edits, and generates reports of ambulatory ECG. This is a measurement of electrical activity of the heart within the living body (in vivo), not an examination of a specimen derived from the body (in vitro).
- Intended Use: The intended use clearly describes recording and analyzing ECG data from patients, not analyzing biological samples.
Therefore, based on the provided information, the SE-2003/SE-2012 Holter System is a non-IVD medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.
It can be used for the following indications:
-
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of drug response in patients taking anti-arrhythmic medications.
-
- Evaluation of patients with pacemakers.
Product codes (comma separated list FDA assigned to the subject device)
DOK, MWJ
Device Description
The Holter System, composed of a Holter recorder and Holter software, is designed to record and analyze continuous long-time (24-192 hours) ECG data. The Holter recorder contains lead wires and removable SD flash card to record ECG signals. The Holter software is installed in generally used PC to analyze recorded ECG data from Holter recorder. Typical recording time of Holter recorder powered by one AAA size battery with removable SD flash card is more than 24 hours up to 192 hours. Recorders are carried around by patients with a set of electrodes arranged by certain rules on them which are connected to recorders by lead wires. Patients are requested to come back to medical treatment site after recording time. The ECG data recorded in Holter recorders will be transferred into PCs and then analyzed, displayed and edited with the Holter software. An analysis report may be finally generated. The introduction of the Holter recorder and Holter software is as follows:
- Holter recorder has two models, the SE-2003 and SE-2012 with the same performance such as sampling rate, analog-to-digital converter (ADC), filter and so on. The only two differences is the number of channels of ECG Waveform and the recording time: SE-2003 is a three channel ECG with 5 or 7 Electrodes cable, with a 192-hour recording capability, and SE-2012 is a twelve channel ECG with 10 Electrodes cable, with a 144-hour recording capability. Both Holter recorders have the following functions:
- Digital Sampling Rate 128~1024 Hz
- Frequency Response 0.05 ~60Hz
- A/D Conversion 8, 12, 16, 18bit
- Record Times of the SE-2003 are 24
192 hours, and SE-2012 are 24144 hours 1.46 inch OLED
Holter software has the following functions:
- Supporting multi-channel beat detection
- Accurate classification of QRS morphology
- Supporting automatic detection of arrhythmia
- Supporting re-analysis
- Strips can be reviewed, edited and saved
- Supporting full disclosure
- Analysis functions including Template, Events, Atrial Fibrillation/ Atrial Flutter (AFib/AFlut), Strips, ST analysis, Pacing analysis, Heart Rate Variability (HRV) analysis. Heart Rate Turbulence (HRT) analysis. Obstructive Sleep Apnea (OSA) analysis, QT analysis, The Alternans of T Wave (TWA) analysis, Waterfall analysis, Ventricular Late Potential (VLP) analysis and Vector ECG (VCG) analysis.
- Supporting creating or modifying scenarios or function pages
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric patients including infants weighing less than 10 kg.
Intended User / Care Setting
trained personnel under the direction of doctors.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the Holter System were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on the Holter System, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 and the IEC 60601-1-2: 2007 standard for EMC.
Bench Testing:
Bench testing was conducted per IEC 60601-2-47: 2012, and all the results show pass.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.
Clinical data: Not applicable.
Summary:
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K043010, K050896, K132437, K142424, K093288
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2016
Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave., Suite 200 Sunnyvale, California 94086
Re: K151787
Trade/Device Name: Holter System, models SE-2003 and SE-2012 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, MWJ Dated: December 29, 2015 Received: January 4, 2016
Dear Mr. Worth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151787
Device Name
Holter System, models SE-2003 and SE-2012
Indications for Use (Describe)
The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.
It can be used for the following indications:
-
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of drug response in patients taking anti-arrhythmic medications.
-
- Evaluation of patients with pacemakers.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
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3
510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
Shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen |
| Preparing date: | December 29, 2015 |
| 2. Device name and
classification: | Device Name: Holter System, models SE-2003 and SE-2012
Classification Name/ Product code:
870.1425 Computer, Diagnostic, Programmable/DQK
870.2800 Electrocardiograph, Ambulatory (Without
Analysis)/MWJ
Regulatory Class: Class II |
| 3.Premarket
Notification Class III
Certification and
Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Mortara Instrument, Inc. H3+, K043010 (SE-2003)
2) Mortara Instrument, Inc. H12+, K050896 (SE-2012)
3) GE Healthcare, MARS Holter Analysis Workstation, K132437
4) North East Monitoring, Inc. DR300 Holter Monitor, K142424
5) CardioNet, Inc. Model CIN 1006 - CardioNet ECG Monitor with Arrhythmia Detection, K093288 |
| 5. Reason for
Submission | New Device. |
| 6. Pre-Submission,
IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | The Holter System, composed of a Holter recorder and Holter
software, is designed to record and analyze continuous
long-time (24-192 hours) ECG data. The Holter recorder |
4
contains lead wires and removable SD flash card to record ECG signals. The Holter software is installed in generally used PC to analyze recorded ECG data from Holter recorder. Typical recording time of Holter recorder powered by one AAA size battery with removable SD flash card is more than 24 hours up to 192 hours. Recorders are carried around by patients with a set of electrodes arranged by certain rules on them which are connected to recorders by lead wires. Patients are requested to come back to medical treatment site after recording time. The ECG data recorded in Holter recorders will be transferred into PCs and then analyzed, displayed and edited with the Holter software. An analysis report may be finally generated. The introduction of the Holter recorder and Holter software is as follows:
- Holter recorder has two models, the SE-2003 and SE-2012 with the same performance such as sampling rate, analog-to-digital converter (ADC), filter and so on. The only two differences is the number of channels of ECG Waveform and the recording time: SE-2003 is a three channel ECG with 5 or 7 Electrodes cable, with a 192-hour recording capability, and SE-2012 is a twelve channel ECG with 10 Electrodes cable,with a 144-hour recording capability. Both Holter recorders have the following functions:
- Digital Sampling Rate 128~1024 Hz
- Frequency Response 0.05 ~60Hz
- A/D Conversion 8, 12, 16, 18bit
- Record Times of the SE-2003 are 24
192 hours, and SE-2012 are 24144 hours 1.46 inch OLED
Holter software has the following functions:
- Supporting multi-channel beat detection
- Accurate classification of QRS morphology
- Supporting automatic detection of arrhythmia
- Supporting re-analysis
- Strips can be reviewed, edited and saved
- Supporting full disclosure
- Analysis functions including Template, Events, Atrial Fibrillation/ Atrial Flutter (AFib/AFlut), Strips, ST
5
analysis, Pacing analysis, Heart Rate Variability (HRV) analysis. Heart Rate Turbulence (HRT) analysis. Obstructive Sleep Apnea (OSA) analysis, QT analysis, The Alternans of T Wave (TWA) analysis, Waterfall analysis, Ventricular Late Potential (VLP) analysis and Vector ECG (VCG) analysis.
- Supporting creating or modifying scenarios or function pages
8. Intended Use: The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.
It can be used for the following indications:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of drug response in patients taking anti-arrhythmic medications.
-
- Evaluation of patients with pacemakers.
9. Predicate Device Comparison
The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters items, detailed comparison can be found in the following tables.
| Item | SE-2003
(Edan Instruments, Inc) | H3+
(Mortara Instrument, Inc) | Comparison
Result |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K043010 | — |
| Indications for Use | The SE-2003/SE-2012 Holter System (including analysis software and recorder) is intended to record, analyze, display, edit and generate report of ambulatory ECG. | The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory | Different |
| Item | SE-2003
(Edan Instruments, Inc) | H3+
(Mortara Instrument, Inc) | Comparison
Result |
| | The Holter System is
intended to be used by
trained personnel under the
direction of doctors. The
analysis results are offered to
doctors on an advisory basis
only. The Holter System is
intended for adult, pediatric
patients including infants
weighing less than 10 kg.
It is mainly used for (but not
limited to) the following
indications:
Evaluation of symptoms
suggesting arrhythmia or
myocardial ischemia. Evaluation of patients
for ST segment changes. Evaluation of drug
response in patients
taking anti-arrhythmic
medications. Evaluation of patients
with pacemakers. | (Holter) monitoring of 24
hours. The Mortara Holter
Recorder H3+ is not a
life-supporting device. It is
diagnostic tool intended to
acquire, record and store ECG
data of patients requiring
ambulatory (Holter)
monitoring of 24 or 48 hours.
Such monitoring is most
frequently used for the
purpose of prospective and
retrospective cardiac data and
arrhythmia analysis.
Holter analysis is appropriate
for the indications below:
Evaluation of adult
patients with symptoms
suggesting arrhythmia Evaluation of adult
patients with pacemakers Reporting of time domain
heart rate variability Evaluation of patients
response after resuming
occupational or
recreational activities
(e.g., after M.I. or cardiac
surgery.) Evaluation of ECG
documenting therapeutic
interventions in
individual patients or
groups of patients Clinical and
epidemiological research
studies Infant patient evaluation
is limited to QRS
detection only | |
| Energy | A single AAA alkaline | A single AAA alkaline battery | Same |
| Item | SE-2003
(Edan Instruments, Inc) | H3+
(Mortara Instrument, Inc) | Comparison
Result |
| used and/or
delivered | battery | | |
| Channels | 1,2,3-Channel | 2,3-Channel | Different |
| Leads | Channel 1, Channel 2,
Channel 3 | Channel 1, Channel 2,
Channel 3 | Same |
| Physical
Design | Length: 76 mm
Width: 49 mm
Thick: 16 mm
Weight: 50 g | Length: 64 mm
Width: 25 mm
Thick: 19 mm
Weight: 28 g | Different |
| Digital
Sampling
Rate | 128~1024 Hz | 180 Hz | Different |
| A/D
Conversion | 8, 12, 16, 18 bit | 12 bit | Different |
| Frequency
Response | 0.05 Hz 60 Hz | 0.05 Hz 48 hours | Different |60 Hz | Same |192 hours | 24
| Input
impedance | ≥20 MΩ | ≥47 MΩ | Different |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-47 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-47 | Same |
| Patient
Contact
Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Record
Times | 24
Table 1: Comparison to Predicate Device(s) between SE-2003 and H3+
6
7
Table 2: Comparison to Predicate Device(s) between SE-2012 and H12+
| Item | SE-2012
(Edan Instruments, Inc) | H12+
(Mortara Instrument, Inc) | Remark |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)
Number | Current Submission | K050896 | — |
| Indications
for Use | The SE-2003/SE-2012 Holter
System (including analysis
software and recorder) is
intended to record, analyze,
display, edit and generate
report of ambulatory ECG.
The Holter System is
intended to be used by trained | The H12+ is indicated for use
in a clinical setting, by
qualified medical
professionals only, for
recording ECG data of
patients requiring ambulatory
(Holter) monitoring of up to
48 hours. Such monitoring is | Different |
| Item | SE-2012 | H12+ | Remark |
| | (Edan Instruments, Inc) | (Mortara Instrument, Inc) | |
| | personnel under the direction
of doctors. The analysis
results are offered to doctors
on an advisory basis only. The
Holter System is intended for
adult, pediatric patients
including infants
weighing less than 10 kg.
It is mainly used for (but not
limited to) the following
indications:
Evaluation of symptoms
suggesting arrhythmia or
myocardial ischemia. Evaluation of patients for
ST segment changes. Evaluation of drug
response in patients
taking anti-arrhythmic
medications. Evaluation of patients
with pacemakers. | most frequently used for the
purpose of prospective and
retrospective cardiac data and
arrhythmia analysis.
Holter analysis is appropriate
for the indications below:
Evaluation of adult
patients with symptoms
suggesting arrhythmia or
myocardial ischemia. Evaluation of adult
patients for ST segment
changes Evaluation of adult
patients with pacemakers Reporting of time
domain heart rate
variability Evaluation of a patients
response after resuming
occupational or
recreational activities
(e.g., after MI. or cardiac
surgery.) Evaluation of ECG
documenting therapeutic
interventions in
individual patients or
groups of patients Clinical and
epidemiological research
studies Infant patient evaluation
is limited to QRS
detection only | |
| Energy
used and/or
delivered | A single AAA alkaline battery | A single AA alkaline battery | Different |
| Channels | 12 Channel | 12 Channel | Same |
| Leads | I, II, III, aVR, aVL, aVF, V1,
V2, V3, V4, V5, V6 | I, II, III, aVR, aVL, aVF, V1,
V2, V3, V4, V5, V6 | Same |
| Physical | Length:76 mm | Length: 64 mm | Different |
| Item | SE-2012
(Edan Instruments, Inc) | H12+
(Mortara Instrument, Inc) | Remark |
| Design | Width:49 mm
Thick:16 mm
Weight: 50 g | Width:91 mm
Thick:25 mm
Weight: 125 g | |
| Digital
Sampling
Rate | 128~1024 Hz | 180 Hz | Different |
| A/D
Conversion | 8, 12, 16, 18 bit | 20 bit | Different |
| Frequency
Response | 0.05 Hz 60 Hz | 0.05 Hz 48 hours | Different |60 Hz | Same |144 hours | 24
| Input
impedance | ≥20 MΩ | ≥47 MΩ | Different |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-47 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-47 | Same |
| Patient
Contact
Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Record
Times | 24
8
9
Table 3: Comparison to Predicate Device(s) between Holter analysis software and the MARS
| Item | Holter Analysis Software
(Edan Instruments, Inc) | MARS
(GE Healthcare) | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)
Number | Current Submission | K132437 | — |
| Indications for
Use | The SE-2003/SE-2012
Holter System (including
analysis software and
recorder) is intended to
record, analyze, display, edit
and generate report of
ambulatory ECG. The Holter
System is intended to be
used by trained personnel
under the direction of
doctors. The analysis results
are offered to doctors on an
advisory basis only. The
Holter System is intended
for adult, pediatric patients | MARS Holter Analysis
Workstation is designed for
acquisition, analysis, edit,
review, report and storage of
ambulatory EGG and
multi-parameter data. Results
of the automated analysis are
intended to assist the
physician in the interpretation
of the recorded data. This
information is not intended to
serve as a substitute for the
physician overread of the
recorded EGG data. The
MARS Holter Analysis | Different |
| Item | Holter Analysis Software
(Edan Instruments, Inc) | MARS
(GE Healthcare) | Remark |
| | including infants
weighing less than 10 kg.
It is mainly used for (but not
limited to) the following
indications:
Evaluation of symptoms
suggesting arrhythmia
or myocardial ischemia. Evaluation of patients
for ST segment
changes. Evaluation of drug
response in patients
taking anti-arrhythmic
medications. Evaluation of patients
with pacemakers. | Workstation is intended to be
used by trained operators
under the direct supervision
of a licensed healthcare
practitioner in a hospital or
clinic environment. Patient
population includes both
adult and pediatric (greater
than 10Kg) human patients.
The MARS Holter Analysis
Workstation provides the user
arrhythmia studies and Holter
analysis capabilities.
Data acquired may be used
for the following indications:
Evaluation of symptoms
that may be caused by
cardiac arrhythmia
and/or conduction
disturbances Evaluation of symptoms
that may be due to
myocardial ischemia Detection of EGG events
that alter prognosis in
certain forms of heart
disease Detection and analysis of
pacemaker function and
failure Determination of cardiac
response to lifestyle Evaluation of therapeutic
interventions Investigations in
epidemiology and
clinical trials | |
| Review
Modes | Strip review, Template
review, Event review,
Trend reviewer, Tabular
and Page review | Strip review, Template
review, Event review, Trend
reviewer, and Page review | Different |
| Trend Graphs | HR, RR, ST, SVE, VE, | HR, RR, ST, SVE, VE | Different |
| Item | Holter Analysis Software
(Edan Instruments, Inc) | MARS
(GE Healthcare) | Remark |
| | SDNN | | |
| Rhythm
Analysis | Bradycardia, Tachycardia,
Ventricular pairs,
Ventricular tachycardia,
Supraventricular pairs,
Long R-R interval, Pause,
Min/max heart rate, ST
depression, ST elevation | Bradycardia, Tachycardia,
Ventricular pairs,
Ventricular tachycardia,
Supraventricular pairs, Long
R-R interval, Pause,
Min/max heart rate,ST
depression, ST elevation | Same |
| ST Segment
Measurement | 3/12 lead ST segment
measurement, max ST
depression, max ST
elevation, 3/12 lead trends | 3/12 lead ST segment
measurement, max ST
depression, max ST
elevation, 3/12 lead trends | Same |
| Pacemaker
Analysis | Atrial, ventricular and dual
pacemaker detection;
capture failure, Output
failure, undersensing | Atrial, ventricular and dual
pacemaker detection;
capture failure, Output
failure, undersensing | Same |
| QT analysis | QT Measurement | QT Measurement | Same |
| HRV analysis | Frequency domain
analysis, Time domain
analysis | Frequency domain analysis,
Time domain analysis | Same |
10
11
Table 4: Comparison to Predicate Device(s) between Holter analysis software and the DR300
| Item | Holter Analysis Recorder &
Software
(Edan Instruments, Inc) | DR300
North East Monitoring | Remark |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)
Number | Current Submission | K142424 | |
| Indications
for Use | The SE-2003/SE-2012 Holter
System (including analysis
software and recorder) is
intended to record, analyze,
display, edit and generate report
of ambulatory ECG. The Holter
System is intended to be used by
trained personnel under the
direction of doctors. The
analysis results are offered to
doctors on an advisory basis
only. The Holter System is
intended for adult, pediatric
patients including infants | Holter Mode: Detection of
Arrhythmias, Efficacy of
Pharmacological Treatment
and Pacemaker Evaluation.
Event Recorder: The event
recorder module is a patient
activated device designed
to record and for diagnostic
evaluation of transient
symptoms (such as
dizziness, palpitations,
syncope, and chest pain).
Once data is recorded, the | Different |
| Item | Holter Analysis Recorder &
Software
(Edan Instruments, Inc) | DR300
North East Monitoring | Remark |
| | weighing less than 10 kg.
It is mainly used for (but not
limited to) the following
indications:
● Evaluation of symptoms
suggesting arrhythmia or
myocardial ischemia.
● Evaluation of patients for
ST segment changes.
● Evaluation of drug response
in patients taking
anti-arrhythmic
medications.
● Evaluation of patients with
pacemakers. | data is transmitted for
evaluation. | |
| Target
Population | for adult, pediatric patients
including infants weighing less
than 10 kg | patients (including infants
weighing less than 10 kg)
who may benefit from
such monitoring | Same |
| Energy
used and/or
delivered | A single AAA alkaline battery | A single AA battery | Different |
| Physical
Design | Length:76 mm
Width:49 mm
Thick:16 mm
Weight: 50 g | Length 86mm (3.9in)
Width: 60mm (2.4in)
Thick: 20mm (0.8in)
Weight: 70.9g (2.5 oz) | Different |
| Digital
Sampling
Rate | 128~1024 Hz | 180 Hz | Different |
| A/D
Conversion | 8, 12, 16, 18 bit | 12 bit | Different |
| Frequency
Response | 0.05 Hz 60 Hz | 0.05 – 70 Hz | Different |144 hours | 336 hours | Different |
| Record
Times | 24
| Item | Holter Analysis Recorder &
Software
(Edan Instruments, Inc) | CIN 1006 - CardioNet
ECG Monitor
(CardioNet Inc.) | Remark |
| 510(k)
Number | Current Submission | K093288 | |
| Indications
for Use | The SE-2003/SE-2012 Holter
System (including analysis
software and recorder) is
intended to record, analyze,
display, edit and generate
report of ambulatory ECG.
The Holter System is intended
to be used by trained
personnel under the direction
of doctors. The analysis results
are offered to doctors on an
advisory basis only. The
Holter System is intended for
adult, pediatric patients
including infants weighing
less than 10 kg.
It is mainly used for (but not
limited to) the following
indications:
● Evaluation of symptoms
suggesting arrhythmia or
myocardial ischemia.
● Evaluation of patients for
ST segment changes.
● Evaluation of drug
response in patients
taking anti-arrhythmic
medications.
● Evaluation of patients
with pacemakers.
● Evaluation of patients
with obstructive sleep
apnea to evaluate possible
nocturnal arrhythmias. | The CardioNet
AmbulatoryECGGMonitor
with Arrhythmia Detection
intended use is for:
- Patients who have a
demonstrated need for
cardiac Monitoring. These
may include but are not
limited to patients who
require Monitoring for: a)
non-life threatening
arrhythmias such as
supraventricular
tachycardias (e.g. atrial
fibrillation, atrial flutter,
PACS, PSVT) and
ventricular ectopy; b)
evaluation of
bradyarrhythmias and
intermittent bundle branch
block, including after
cardiovascular surgery and
myocardial infarction; and
c) arrhythmias associated
with co-morbid conditions
such as hyperthyroidism or
chronic lung disease. - Patients with symptoms
that may be due to cardiac
arrhythmias. These may
include but are not limited
to symptoms such as: a)
dizziness or
lightheadedness; b)
syncope of unknown
etiology in which
arrhythmias are suspected or
need to be excluded; c)
dyspnea (shortness of | Different |
| Item | Holter Analysis Recorder &
Software
(Edan Instruments, Inc) | CIN 1006 - CardioNet
ECG Monitor
(CardioNet Inc.) | Remark |
| | | breath). - Patients with palpitations
with or without known
arrhythmias to obtain
correlation of rhythm with
symptoms. - Patients who require
outpatient monitoring of
antiarrhythmic therapy: a)
Monitoring of therapeutic
and potential proarrhythmic
effects of membrane active
drugs, b) Monitoring of
effect of drugs to control
ventricular rate in various
atrial arrhythmias (e.g. atria]
fibrillation). - Patients recovering from
cardiac surgery who are
indicated for outpatient
arrhythmia Monitoring. - Patients with diagnosed
sleep disordered breathing
including sleep apnea
(obstructive, central) to
evaluate possible nocturnal
arrhythmias - Patients requiring
arrhythmia evaluation of
etiology of stroke or
transient cerebral ischemia,
possibly secondary to atrial
fibrillation or atrial flutter. - Patients requiring
measurement, analysis and
reporting of QT interval,
excluding patients with a
documented history of
sustained atrial fibrillation
or atrial flutter | |
| Item | Holter Analysis Recorder &
Software
(Edan Instruments, Inc) | CIN 1006 - CardioNet
ECG Monitor
(CardioNet Inc.) | Remark |
| Record
Times | 24~144 hours | monitoring for potential
arrhythmias based on risk
factors (e.g. atrial
fibrillation). - Patients requiring
measurement of ST segment
changes. The device is not
intended to sound any
alarms for ST segment
changes.
720 hours | Different |
12
Table 5: Comparison to Predicate Device between Holter analysis software and CIN 1006 - CardioNet ECG Monitor
13
14
15
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
10. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Holter System were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- Σ Cytotoxicity
- Σ Skin Sensitization
- Σ Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Holter System, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 and the IEC 60601-1-2: 2007 standard for EMC.
Bench Testing
Bench testing was conducted per IEC 60601-2-47: 2012, and all the results show pass.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was
16
provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.
Clinical data: Not applicable.
Summary
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
11. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the Holter System device should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject Holter System devices are substantially equivalent to the predicate devices.