PC ECG

• K Number: K160876
• Device Name: PC ECG
• Manufacturer: EDAN INSTRUMENTS, INC.
• Date Cleared: 2017-02-15 ( 322 days)
• Product Code: DPS
• Regulation Number: 870.2340

Intended Use

The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements is offered to clinicians on an advisory basis only.

Device Description

The SE-12/12 Express/1200/1200 Express Electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms, and be powered by the mains supply or battery. And the system has advanced performance and high reliability due to high resolution thermal recorder, 32-bit processor and a large-capacity memorizer. Design of the system took much consideration on ergonomics so the size is suitable for clinic and hospital uses. There are four selectable modes in the system, including manual, auto, rhythm, R-R analysis or VCG, and VCG is configured with SE-12 Express & SE-1200 Express. SE-12 and SE-1200 share the same single color LCD screen of which the resolution is 320×240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800×600 multicolor LCD screen. Moreover, SE-12 Express is configured with stress ECG function, which will allow to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before leaving hospital, and assess the effect of the treatment.

Predicate Devices

K102830, K131503, K060167, K152427

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard electrocardiograph functionality and hardware components. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "interpreted ECG with measurements is offered to clinicians on an advisory basis only" suggests a rule-based or algorithmic interpretation, not necessarily AI/ML.

Therapeutic

No.
This device is an electrocardiograph used for diagnosis, not for therapy or treatment.

Diagnostic

Yes

The device, an electrocardiograph, acquires ECG signals which "can help users to analyze and diagnose heart disease." Additionally, one model includes a stress ECG function "which will allow to diagnose concealed coronary heart disease and atypical angina pectoris." These statements indicate its use in diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as a thermal recorder, 32-bit processor, large-capacity memorizer, LCD screen, and battery, indicating it is a physical device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
• Device Function: The SE-12 series electrocardiograph acquires ECG signals from the body surface using electrodes. This is a non-invasive procedure performed on the patient's body, not on a sample taken from the body.
• Intended Use: The intended use is to acquire ECG signals and help users analyze and diagnose heart disease based on these signals. This is a diagnostic process based on physiological measurements from the body, not on laboratory testing of biological samples.

Therefore, the SE-12 series electrocardiograph falls under the category of a medical device used for physiological monitoring and diagnosis, but it does not meet the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements is offered to clinicians on an advisory basis only.

Product codes (comma separated list FDA assigned to the subject device)

DPS

Device Description

The SE-12/12 Express/1200/1200 Express Electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms, and be powered by the mains supply or battery. And the system has advanced performance and high reliability due to high resolution thermal recorder, 32-bit processor and a large-capacity memorizer. Design of the system took much consideration on ergonomics so the size is suitable for clinic and hospital uses. There are four selectable modes in the system, including manual, auto, rhythm, R-R analysis or VCG, and VCG is configured with SE-12 Express & SE-1200 Express. SE-12 and SE-1200 share the same single color LCD screen of which the resolution is 320x240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800x600 multicolor LCD screen. Moreover, SE-12 Express is configured with stress ECG function, which will allow to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before leaving hospital, and assess the effect of the treatment.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

body surface

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

hospitals or healthcare facilities by doctors and trained healthcare professionals.

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:
Biocompatibility testing: Conducted in accordance with ISO 10993-1. Included Cytotoxicity, Skin Sensitization, and Skin Irritation tests.
Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1:2005/A1: 2012 for safety and IEC 60601-1-2: 2007 for EMC.
Bench Testing: Conducted per IEC 60601-2-25: 2011, all results passed.
Software Verification and Validation Testing: Conducted as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern.
Battery Testing: Conducted per UL 2054, UL60950-1:2007, and IEC 61233:2012, all results passed.
Clinical data: Not applicable.
Key results: The non-clinical data support the safety of the device and software verification and validation demonstrate that SE-12 series electrocardiograph device should perform as intended in the specified use conditions. All data demonstrates that the subject devices perform comparably 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.

K102830, K131503, K060167, K152427

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

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 15, 2017

Edan Instruments, Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089

Re: K160876 Trade/Device Name: Electrocardiograph, Models: SE-12, SE-12 Express, SE-1200, and SE-1200 Express Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 5, 2017 Received: January 9, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mude Yellen
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) K160876

Device Name

Device Name: Electrocardiograph Model: SE-12, SE-12 Express, SE-1200, and SE-1200 Express

Indications for Use (Describe)

The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements 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
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
Shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: [phone]
Fax: [phone] |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:
Preparing date: | Alice Yan
January 5, 2016 |
| 2. Device name and
classification: | Device Name: Electrocardiograph
Model: SE-12, SE-12 Express, SE-1200, and SE-1200 Express
Classification Name/ Product code:
870.2340 Electrocardiograph/DPS
Regulatory Class: Class II |
| 3. Predicate Device(s): | 1) EDAN Instrument, Electrocardiograph, model SE-12, SE-12
Express, SE-1200, and SE-1200 Express, K102830
2) EDAN Instrument, Electrocardiograph, model SE-601, K131503
3) Cardiac Science Corporation, model Atria 6100, K060167
4) EDAN Instrument, PC ECG, model SE-1515, K152427 |
| 4. Reason for
Submission | Technology change |
| 5. Pre-Submission,
IDE | Not applicable, there is no prior submission. |
| 6. Device Description: | The SE-12/12 Express/1200/1200 Express Electrocardiograph
gathers ECG signals of 12 leads simultaneously. It displays the
operation menu, ECG parameters as well as electrocardiograms, and
be powered by the mains supply or battery. And the system has
advanced performance and high reliability due to high resolution
thermal recorder, 32-bit processor and a large-capacity memorizer.
Design of the system took much consideration on ergonomics so the
size is suitable for clinic and hospital uses.
There are four selectable modes in the system, including manual, |

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auto, rhythm, R-R analysis or VCG, and VCG is configured with SE-12 Express & SE-1200 Express. SE-12 and SE-1200 share the same single color LCD screen of which the resolution is 320×240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800×600 multicolor LCD screen. Moreover, SE-12 Express is configured with stress ECG function, which will allow to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before leaving hospital, and assess the effect of the treatment. The intended use of SE-12 series electrocardiograph is to acquire 7. Intended Use: ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

8. 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-12, SE-12 Express,
SE-1200, and SE-1200 Express) | Proposed device
(SE-12, SE-12 Express,
SE-1200, and SE-1200 Express) | Comparison
Result |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K102830 | Current Submission | — |
| Intended Use | The intended use of the
12-channel electrocardiograph is
to acquire ECG signals from
adult and pediatric patients
through body surface ECG
electrodes. The
electrocardiograph is only
intended to be used in hospitals
or healthcare facilities by doctors
and trained healthcare
professionals. The cardiogram
recorded by the | The intended use of SE-12 series
electrocardiograph is to acquire
ECG signals from adult and
pediatric patients through body
surface ECG electrodes. The
electrocardiograph is only
intended to be used in hospitals
or healthcare facilities by doctors
and trained healthcare
professionals. The cardiogram
recorded by the
electrocardiograph can help users | Same |

Table 1: Comparison between the current SE-12 series and previous cleared system
electrocardiograph can help users
to analyze and diagnose heart
disease. However, the interpreted
ECG with measurements and
interpretive statements is offered
to clinicians on an advisory basis
only.		to analyze and diagnose heart
disease. However, the interpreted
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
ANSI/AAMI EC11
IEC/EN 60601-2-51	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
Ingress rating	IPX0	IPX0	Same
Environment Specifications
Temperature
Transport & Storage	-20°C (-4°F) ~ +55°C (+131°F)	-20°C (-4°F) ~ +55°C (+131°F)	Same
Working	+5°C (+41°F) ~ +40°C (+104°F)	+5°C (+41°F) ~ +40°C (+104°F)	Same
Relative Humidity:
Transport & Storage	25%~93%
Non-Condensing	25%~93%
Non-Condensing	Same
Working	25% RH ~ 80% RH
Non-Condensing	25% RH ~ 80% RH
Non-Condensing	Same
Atmospheric Pressure:
Transport & Storage		700 hPa ~ 1060 hPa	Operating Voltage =	700 hPa ~ 1060 hPa	Operating Voltage =	Same
Working	Mains Supply:	860 hPa ~ 1060 hPa	100V-240V~	860 hPa ~ 1060 hPa	100V-240V~	Same	Same
Operating frequency = 50 Hz /
60 Hz		Operating frequency = 50 Hz / 60 Hz	Same
Input Power = 70VA		Input Current = 0.9-0.4A
Or Input power = 96VA	Different
	Rated voltage = 14.8 V	Rated voltage = 14.8 V	Same
	SE-12 Express&SE-1200
Express: Rated capacity =
4400mAh	SE-12 Express&SE-1200
Express: Rated capacity =
5000mAh	Different
	SE-12& SE-1200: Rated
capacity =2200mAh	SE-12& SE-1200: Rated capacity
= 2500mAh
Built-in Lithium
Battery Pack:	When the battery is fully
charged, SE-12&SE-1200 can
work
normally about 4 hours, and it
can continually print about 1.5
hours in the manual mode or
print about 300 ECG reports of
$3×4+1R$ in the auto mode; SE-12
Express &SE-1200 Express can
work
normally about 5 hours, and it
can continually print about 2.5
hours in the manual mode or
print about 350 ECG reports of
$3×4+1R$ in the auto mode.	When the battery is fully
charged, SE-12& SE-1200 can
work normally about 4 hours, and
it can continually print about 1.5
hours in the manual mode or
print about 300 ECG reports of
$3×4+1R$ in the auto mode; SE-12
Express& SE-1200 Express can
work normally about 5 hours, and
it can continually print about 2.5
hours in the manual mode or
print about 350 ECG reports of
$3×4+1R$ in the auto mode.	Same
	Performance Specifications
	Recording
Recorder:	Thermal dot-matrix recorder	Thermal dot-matrix recorder	Same
		8 dots per mm / 200 dots per inch
(amplitude axes)	8 dots per mm / 200 dots per inch
(amplitude axes)
	Printing Density	40 dots per mm / 1000 dots per
inch (time axes, @ 25 mm/s)	40 dots per mm / 1000 dots per
inch (time axes, @ 25 mm/s)	Same
	Recorder Paper:	Folded thermal paper:
210mm×295mm×100pages	Folded thermal paper:
210mm×295mm×100pages
Folded thermal paper:
215mm×280mm×100pages
(Optional)		Folded thermal paper:
215mm×280mm×100pages
(Optional)	Same
Rolled thermal paper:
210mm×30m (Optional)		Rolled thermal paper:
210mm×30m (Optional)
Effective Width:		203 mm	203mm	Same

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6

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	5mm/s, 6.25mm/s, 10mm/s,	5mm/s, 6.25mm/s, 10mm/s,
Paper Speed:	12.5mm/s, 25mm/s, 50mm/s
(±3%)	12.5mm/s, 25mm/s, 50mm/s
(±3%)	Same
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	24 bits	24 bits	Same
Resolution:	2.52uV/LSB	2.52uV/LSB	Same
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
Gain:	2.5, 5, 10, 20, 10/5, AGC
(mm/mV)	2.5, 5, 10, 20, 10/5, AGC
(mm/mV)	Same
Input Impedance:	≥50 MΩ(10 Hz)	≥50 MΩ(10 Hz)	Same
Input Circuit
Current:	≤0.01μA	≤0.01μA	Same
Input Voltage
Range	≤±5 mVpp	≤±5 mVpp	Same
Calibration
Voltage:	1 mV±3%	1 mV±3%	Same
DC Offset
Voltage:	±600 mV	±600 mV	Same
Noise:	≤12.5 µVp-p	≤12.5 µVp-p	Same
Multi-channel
Crosstalk	≤0.5 mm	≤0.5 mm	Same
Filter	AC Filter: On / Off	AC Filter: On / Off	Same
	DFT Filter: 0.05Hz / 0.15Hz /
0.25Hz / 0.32Hz / 0.5Hz /
0.67Hz	DFT Filter: 0.05Hz / 0.15Hz /
0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz	Same
	EMG Filter: 25Hz / 35Hz / 45Hz
/ OFF	EMG Filter: 25Hz / 35Hz / 45Hz
/ OFF	Same
	LOWPASS Filter: 150Hz /
100Hz / 75Hz	LOWPASS Filter: 150Hz / 100Hz
/ 75Hz	Same
	CMRR	≥115 dB	≥115 dB
	Sampling
Frequency	1000 Hz	1000 Hz
Pacemaker Detection
Amplitude	±2 to ±700 mV	±2 to ±700 mV	Same
Width	0.1 to 2.0 ms	0.1 to 2.0 ms	Same
Sampling
Frequency	10,000/sec/channel	10,000/sec/channel	Same
External Input/ Output
Input	≥100 kΩ; Sensitivity 10
mm/V±5%;
Single ended	≥100 kΩ; Sensitivity 10
mm/V±5%;
Single ended	Same
Output	≤100Ω; Sensitivity 1 V/mV ±5%;
Single ended	≤100Ω; Sensitivity 1 V/mV ±5%;
Single ended	Same

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Table 2: Comparison between SE-12 series and SE-601 series

| Item | Predicate device
(SE-601C) | Proposed device
(SE-12, SE-12 Express,
SE-1200, and SE-1200 Express) | Comparison
Result |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K131503 | Current Submission | — |
| Intended Use | The intended use of SE-601 is to
acquire ECG signals from adult
and pediatric patients through
body surface ECG electrodes.
The electrocardiograph is only
intended to be used in hospitals or
healthcare facilities by doctors
and trained healthcare
professionals. The cardiogram
recorded by the
electrocardiograph can help users
to analyze and diagnose heart
disease. However, the interpreted
ECG with measurements and
interpretive statements is only
intended to be used on adult
patients and is offered to
clinicians on an advisory basis
only. | The intended use of SE-12 series
electrocardiograph is to acquire
ECG signals from adult and
pediatric patients through body
surface ECG electrodes. The
electrocardiograph is only
intended to be used in hospitals or
healthcare facilities by doctors
and trained healthcare
professionals. The cardiogram
recorded by the
electrocardiograph can help users
to analyze and diagnose heart
disease. However, the interpreted
ECG with measurements and
interpretive statements is offered
to clinicians on an advisory basis
only. | Same |
| Transmitting
Frequency | 2412-2497MHz | 2400-2497MHz | |
| Frequency Band | 2412-2497MHz | 2400-2497MHz | |
| Modulation Type | DSSS, CCK | DSSS, CCK,OFDM | Different |
| Transmitting
Power | 18dBm | 6-17dBm | |
| Effective | 18dBm | 6-17dBm | |

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Radiated Power

Table 3: Comparison between predicate device Atria 6100 and the proposed system

| Item | Predicate device
(Atria 6100) | Proposed device
(SE-12, SE-12 Express,
SE-1200, and SE-1200 Express) | Comparison
Result |
|--------------|----------------------------------|----------------------------------------------------------------------------|----------------------|
| K# | K060167 | Current Submission | — |
| Screen Size | 640480 | 320240 (SE-12, SE-1200)
800*600(SE-12Express,
SE-1200Express) | Different |
| SW Algorithm | Glasgow | Glasgow | Same |

Table 2-4: Comparison between predicate device SE-1515 (K152427) and SE-12, SE-12 Express, SE-1200.
and SE-1200 Express

| Item | Predicate device
(SE-1515) | Proposed device
(SE-12, SE-12 Express,
SE-1200, and SE-1200 Express) | Comparison
Result |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K152427 | Current Submission | |
| Intended Use | SE-1515 PC ECG is intended to
acquire, process and store ECG
signals from adult and pediatric
patients undergoing stress exercise
test or resting test. The SE-1515 PC
ECG is intended to be used only in
hospitals and healthcare facilities by
doctors and trained healthcare
professionals. The cardiogram
recorded by the SE-1515 PC ECG
can help users to analyze and
diagnose heart diseases. However,
the ECG with measurements and
interpretive statements is offered to
clinicians on an advisory basis only.
It is mainly used in the ECG
Outpatient Department and Physical
Examination Department. | The intended use of SE-12 series
electrocardiograph is to acquire ECG
signals from adult and pediatric
patients through body surface ECG
electrodes. The electrocardiograph is
only intended to be used in hospitals
or healthcare facilities by doctors and
trained healthcare professionals. The
cardiogram recorded by the
electrocardiograph can help users to
analyze and diagnose heart disease.
However, the interpreted ECG with
measurements and interpretive
statements is offered to clinicians on
an advisory basis only. | different |
| SW Algorithm | SEMIP | SEMIP | Same |

As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, and do not raise different questions of safety or effectiveness. As

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demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the Edan SE-12 series electrocardiograph.

9. Performance Data:

Non-clinical data:

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for SE-12 series electrocardiograph is 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 surface 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 SE-12 series electrocardiograph, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standard for safety and the IEC 60601-1-2: 2007 standard for EMC.

Bench Testing

Bench testing was conducted per IEC 60601-2-25: 2011, 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.

Battery Testing

Testing on battery are conducted per UL 2054, UL60950-1:2007 and IEC 61233:2012, and results show pass for all testing items.

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

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device.

10. Conclusion

The non-clinical data support the safety of the device and software verification and validation demonstrate that SE-12 series electrocardiograph 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 SE-12 series electrocardiograph device is substantially equivalent to the predicate devices.