← Product Code [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS) · K171943
# Electrocardiograph (K171943)
_Edan Instruments, Inc. · DPS · Sep 25, 2017 · Cardiovascular · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K171943
## Device Facts
- **Applicant:** Edan Instruments, Inc.
- **Product Code:** [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS.md)
- **Decision Date:** Sep 25, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2340
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Pediatric
## Indications for Use
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
## Device Story
3-channel electrocardiograph (SE-3, SE-300A, SE-300B, SE-301) acquires 12-lead ECG signals simultaneously via body surface electrodes; processes signals using SEMIP algorithm (V1.7 or V1.8) to provide measurements and interpretive statements; outputs 3-lead reports on thermal paper; displays operation menu, parameters, and waveforms. Used in hospitals/healthcare facilities by physicians and trained professionals. Provides advisory diagnostic support to clinicians; aids in heart disease analysis. Benefits include automated diagnostic assistance and improved clinical workflow through digital signal processing and reporting.
## Clinical Evidence
No clinical data. Evidence consists of non-clinical bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing per IEC 60601-2-25. ECG interpretation features validated via database testing.
## Technological Characteristics
12-lead ECG acquisition; 12-bit or 24-bit A/D resolution; thermal dot-matrix recorder; 14.8V lithium battery; Wi-Fi connectivity (2.4 GHz). Safety standards: IEC 60601-1:2005/A1:2012, IEC 60601-2-25:2011. Software: SEMIP algorithm (V1.7/V1.8).
## Regulatory Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
## Predicate Devices
- EDAN Instrument, Inc. SE-3, SE-300A, SE-300B ([K091513](/device/K091513.md))
## Reference Devices
- EDAN Instrument, Inc. SE-601C ([K131503](/device/K131503.md))
- EDAN Instrument, Inc. SE-12 Series ([K160876](/device/K160876.md))
## Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2017
Edan Instruments, Inc. % Doug Worth Sr. Dir. US RA/QA 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089
Re: K171943
Trade/Device Name: Electrocardiographs: SE-301. SE-300A. SE-300B. SE-3 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 19, 2017 Received: June 28, 2017
Dear Doug 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 of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 (DICE) 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 (DICE) 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.
M.R. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K171943
#### Device Name
Electrocardiograph, models SE-3, SE-300A, SE-300B and SE-301
Indications for Use (Describe)
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
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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# 510(K) Summary
# Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc
#15 Jinhui Road,Jinsha Community,
Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
518067 P.R. China
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:
Preparing date: | Alice Yang
June 19, 2017 |
| 2. Device name and
classification: | Device Name: Electrocardiograph
Model: SE-3, SE-300A, SE-300B and SE-301
Classification Name/ Product code:
870.2340 Electrocardiograph/DPS
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) EDAN Instrument, Inc. SE-3, SE-300A,SE-300B, K091513
2) EDAN Instrument, Inc. SE-601C, K131503 (reference)
3) EDAN Instrument, Inc. SE-12 Series, K160876 (reference) |
| 5. Reason for
Submission | The SE-3, SE-300A and SE-300B Electrocardiograph received
FDA 510(k) clearance on July 24, 2009(K091513); while
SE-301 is a newly designed system which is developed based
on SE-3 but with better designed hardware structure,
appearance, display, battery adapter together with a Wi-Fi
module, and not cleared yet. The changes of SE-3, SE-300A,
SE-300B in this submission compared to the last cleared
version are mainly in resolution, color of screen, lithium battery
pack, DE12 ECG board and assemble of screen. |
| 6. Pre Submission | Not applicable, there is no prior submission. |
| 7. Device Description: | SE-3 Series (including SE-3, SE-300A, SE-300B, and
SE-301) 3-channel electrocardiograph gathers ECG signals
of 12 leads simultaneously. While all 12 leads are recorded
and analyzed, printouts will only have 3 leads on a page,
with 4 pages in series to output all 12 leads. It displays the
operation menu, ECG parameters as well as
electrocardiograms. |
| 8. Intended Use: | The intended use of the 3-Channel Electrocardiograph is to
acquire ECG signals from adult and pediatric patients
(beginning at birth through 21 years of age) through body
surface ECG electrodes. The electrocardiograph is intended to
be used only in hospitals or healthcare facilities by doctors and
trained healthcare professionals. The cardiogram recorded by |
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# IDE
the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
## 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, which are shown in the following tables in details.
| Item | Predicate device
(SE-3, SE-300A,SE-300B) | Proposed device
(SE-3, SE-300A, SE-300B) | Comparison
Result |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K091513 | Current Submission | — |
| Intended Use | The intended use of SE-3
is to acquire ECG signals
from adult and pediatric
patients through body
surface ECG electrodes.
The electrocardiograph is
intended to be used only in
hospitals or healthcare | The intended use of the
3-Channel
Electrocardiograph is to
acquire ECG signals from
adult and pediatric patients
(beginning at birth through
21 years of age) through
body surface ECG | Same |
| | facilities by doctors and
trained healthcare
professionals. The
cardiogram recorded by
SE-3 can help users to
analyze and diagnose heart
disease. However, the
ECG with measurements
and interpretive statements
is offered to clinicians on
an advisory basis only. | electrodes. The
electrocardiograph is
intended to be used only in
hospitals or healthcare
facilities by doctors and
trained healthcare
professionals. The
cardiogram recorded by
the 3-Channel
Electrocardiograph can
help users to analyze and
diagnose heart disease.
However, the ECG with
measurements and
interpretive statements is
offered to clinicians on an
advisory basis only. | |
| Safety Specifications | | | |
| Safety Standards | IEC 60601-1:1988+A1+A2,
EN 60601-1:1990+A1+A2,
IEC/EN 60601-1-2: 2001+A1,
IEC/EN60601-2-25
NSI/AAMI EC-11 | IEC 60601-1:2005
EN 60601-1:2006
EN 60601-1-2:2007
IEC 60601-1-2:2007
IEC/EN60601-2-25:2011 | Different |
| Anti-electric-shock
type: | Class I with internal power
supply | Class I with internal power
supply | Same |
| Anti-electric-shock
degree: | Type CF | Type CF | Same |
| Degree of protection
against harmful ingress
of water: | Ordinary equipment (Sealed
equipment without liquid
proof) | Ordinary equipment (Sealed
equipment without liquid
proof) | Same |
| Disinfection/sterilization
method: | Refer to the user manual for
details | Refer to the user manual for
details | Same |
| Degree of safety of
application in the
presence of flammable
gas: | Equipment not suitable for use
in the presence of flammable
gas | Equipment not suitable for use
in the presence of flammable
gas | Same |
| Working mode: | Continuous operation | Continuous operation | Same |
| EMC: | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same |
| Environment Specifications | | | |
| Temperature | | | |
| Transport | -20°C~50°C | -20°C ~ +55°C | Different |
| Storage | -10°C~40°C | -20°C ~ +55°C | Different |
| Working | 5 °C ~40 °C | +5°C ~ +40°C | Same |
| Relative Humidity: | | | |
| Transport & Storage | 25% RH ~ 95% RH
Non Condensing | 25% RH ~ 93% RH
Non Condensing | Different |
| Working | 25% RH ~ 85% RH
Non-Condensing | 25% RH ~ 80% RH
Non-Condensing | Different |
| | | | |
| Atmospheric Pressure: | | | |
| Transport & Storage | 700 hPa ~ 1060 hPa | 700 hPa ~ 1060 hPa | Same |
| Working | 800 hPa ~ 1060 hPa | 800 hPa ~ 1060 hPa | Same |
| Power Supply Specifications | | | |
| | Operating voltage =100 V-115
V~/220 V-240 V~ | Operating voltage
=100 V-115 V~/220 V-240 V~ | Same |
| Mains Supply: | Operating frequency = 50 Hz /
60 Hz | Operating frequency = 50 Hz /
60 Hz | Same |
| | input power = 35 VA | input power = 35 VA | Same |
| | Rated voltage = 14.4 V | Rated voltage = 14.8 V | |
| | Rated capacity =1600 mAh | Rated capacity = 2500 mAh | |
| Built-in Lithium Battery
Pack: | When the battery is fully
charged, SE-3 can work
normally 6 hours. | When the battery is fully
charged, the 3-channel
electrocardiograph can work
normally about 6.5 hours. It
can continuously record about
3 hours in Manual mode, and
record 330 reports at most in
the AUTO mode. | Different |
| | Cycle life ≥ 300 times | Cycle life ≥ 300 times | Same |
| Performance Specifications | | | |
| Recording
Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same |
| | Folded thermal paper | Folded thermal paper, | |
| Recorder Paper: | Rolled thermal paper | Rolled thermal paper, | Same |
| Effective Width: | 72 mm | 72 mm | Same |
| Paper Speed: | 5 mm/s, 10 mm/s, 12.5 mm/s,
25 mm/s, 50 mm/s (±3%) | 5 mm/s, 6.25 mm/s, 10 mm/s,
12.5 mm/s, 25 mm/s, 50 mm/s
(±3%) | Different |
| Accuracy of data: | ±5% (x-axis), ±5% (y-axis) | ±5% (x-axis), ±5% (y-axis) | Same |
| HR Recognition | | | |
| Technique: | Peak-Peak Detection | Peak-Peak Detection | Same |
| HR Range: | 30 BPM ~ 300 BPM | 30 BPM ~ 300 BPM | Same |
| Accuracy: | ±1 BPM | ±1 BPM | Same |
| ECG Unit | | | |
| Leads: | Standard 12 leads | Standard 12 leads | Same |
| Acquisition Mode: | Simultaneously 12 leads | Simultaneously 12 leads | Same |
| A/D Resolution: | 12 bits | 12 bits or
24 bits (optional, with DE12
ECG board) | Different |
| Time Constant: | ≥ 3.2 s | ≥ 3.2 s | Same |
| Frequency Response: | 0.05 Hz ~ 150 Hz (-3 dB) | 0.05 Hz ~ 150 Hz (-3 dB) | Same |
| Input Impedance: | ≥50 MΩ (10 Hz) | ≥50 MΩ (10 Hz) | Same |
| Input Circuit Current: | ≤0.05 μA | ≤0.05 μA /
≤0.01 μA (optional, with DE12 | Different |
| | | | |
| | | ECG board) | |
| Input Voltage Range
Calibration Voltage: | $\leq$ ±5 mVpp
1 mV±3% | $\leq$ ±5 mVpp
1 mV±3% | Same |
| | | ±500 mV / | |
| DC Offset Voltage: | ±500 mV | ±600 mV (optional, with DE12
ECG board) | Different |
| Noise: | $\leq$ 12.5 $\mu$ Vp-p | $\leq$ 12.5 $\mu$ Vp-p | Same |
| Multi-channel Crosstalk | $\leq$ 0.5 mm | $\leq$ 0.5 mm | Same |
| | AC Filter: On / Off | AC Filter: On / Off | Same |
| | | DFT Filter: 0.05Hz / 0.15Hz / | |
| | DFT Filter: 0.05Hz / 0.15Hz /
0.25Hz / 0.5Hz | 0.25Hz / 0.32Hz / 0.5Hz /
0.67Hz | Different |
| Filter | EMG Filter: 25Hz / 35Hz /
OFF | EMG Filter: 25Hz / 35Hz /
45Hz / OFF | Different |
| | LOWPASS Filter:150Hz /
100Hz / 75Hz | LOWPASS Filter:150Hz /
100Hz / 75Hz | Same |
| | $\geq$ 110 dB | $\geq$ 110dB /
$\geq$ 115dB (optional, with DE12
ECG board) | Different |
| CMRR | | | |
| Sampling Frequency | 1000 Hz | 1000 Hz | Same |
| External Input/ Output | | | |
| Input | $\geq$ 100 kΩ; Sensitivity 10
mm/V±5%;
Single ended | $\geq$ 100 kΩ; Sensitivity 10
mm/V±5%;
Single ended | Same |
| Output | $\leq$ 100Ω; Sensitivity 1 V/mV
±5%;
Single ended | $\leq$ 100Ω; Sensitivity 1 V/mV
±5%;
Single ended | Same |
Table 1: Comparison between predicate device SE-3, SE-300B (K091513) and proposed device SE-3, SE-300A, SE-300B
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Table 2: Comparison between predicate device SE-3, SE-300B (K091513) and proposed device SE-301
| Item | Predicate device
(SE-3, SE-300A,SE-300B) | Proposed device
(SE-301) | Comparison
Result |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K091513 | Current Submission | — |
| Intended Use | The intended use of SE-3 is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-3 can help users to analyze and diagnose heart disease. However, the ECG | The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The | Same |
| | with measurements and
interpretive statements is
offered to clinicians on an
advisory basis only. | cardiogram recorded by the
3-Channel
Electrocardiograph can help
users to analyze and
diagnose heart disease.
However, the ECG with
measurements and
interpretive statements is
offered to clinicians on an
advisory basis only. | |
| Electronic Safety | | | |
| Comply with: | IEC 60601-1:1988+A1+A2,
EN 60601-1:1990+A1+A2,
IEC/EN 60601-1-2: 2001+A1,
IEC/EN60601-2-25 NSI/AAMI
EC-11 | IEC 60601-1:2005/A1:2012
EN 60601-1:2006/A1:2013
IEC 60601-1-2:2007
EN 60601-1-2:2007/AC:2010
IEC 60601-2-25:2011 | Different |
| Anti-electric-shock type: | Class I with internal power
supply | Class I with internal power
supply | Same |
| Anti-electric-shock
degree: | Type CF | Type CF | Same |
| Degree of protection
against harmful ingress
of water: | Ordinary equipment (Sealed
equipment without liquid proof) | Ordinary equipment (Sealed
equipment without liquid proof)…
---
**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K171943](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K171943)
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