PC ECG

K160876 · Edan Instruments, Inc. · DPS · Feb 15, 2017 · Cardiovascular

Device Facts

• Record ID: K160876
• Device Name: PC ECG
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

The SE-12 series electrocardiograph acquires 12-lead ECG signals via body surface electrodes; utilizes a 32-bit processor and thermal dot-matrix recorder for signal processing and output. Operated by physicians or trained healthcare professionals in clinical/hospital settings. Features include manual, auto, rhythm, R-R analysis, and VCG modes (VCG on specific models); stress ECG function (SE-12 Express) for coronary heart disease assessment. Device displays ECG parameters and waveforms on integrated LCD screens (320x240 or 800x600). Interpreted ECG data and measurements are provided to clinicians as advisory information to support heart disease diagnosis and treatment assessment. System powered by mains or internal lithium battery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), electrical safety, EMC, software verification/validation, and battery testing (UL 2054, IEC 61233).

Technological Characteristics

12-lead ECG acquisition; 32-bit processor; thermal dot-matrix recorder (8 dots/mm amplitude, 40 dots/mm time); 24-bit A/D resolution; input impedance ≥50 MΩ; CMRR ≥115 dB; sampling frequency 1000 Hz. Connectivity includes wireless (DSSS, CCK, OFDM). Powered by mains or internal lithium battery. Safety standards: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-2-25:2011.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition for the analysis and diagnosis of heart disease in hospital or healthcare facility settings.

Regulatory Classification

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, Electrocardiograph, model SE-12, SE-12 Express, SE-1200, and SE-1200 Express (K102830)
• EDAN Instrument, Electrocardiograph, model SE-601 (K131503)
• Cardiac Science Corporation, model Atria 6100 (K060167)
• EDAN Instrument, PC ECG, model SE-1515 (K152427)

Submission Summary (Full Text)

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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) | |
|----------------------------------------------------------------|---------------------------------------------------------------|
| <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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

| Table 1: Comparison between the current SE-12 series and previous cleared system | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------|---------------------|------|------|
| | | | | | | | |
| electrocardiograph can help users<br>to analyze and diagnose heart<br>disease. However, the interpreted<br>ECG with measurements and<br>interpretive statements is offered<br>to clinicians on an advisory basis<br>only. | | to analyze and diagnose heart<br>disease. However, the interpreted<br>ECG with measurements and<br>interpretive statements is offered<br>to clinicians on an advisory basis<br>only. | | | | | |
| <b>Safety Specifications</b> | | | | | | | |
| <b>Safety Standards</b> | IEC 60601-1:1988+A1+A2,<br>EN 60601-1:1990+A1+A2,<br>IEC/EN 60601-1-2: 2001+A1,<br>IEC/EN60601-2-25<br>ANSI/AAMI EC11<br>IEC/EN 60601-2-51 | IEC 60601-1:2005<br>EN 60601-1:2006<br>EN 60601-1-2:2007<br>IEC 60601-1-2:2007<br>IEC/EN60601-2-25:2011 | Different | | | | |
| <b>Anti-electric-shock type:</b> | Class I with internal power supply | Class I with internal power supply | Same | | | | |
| <b>Anti-electric-shock degree:</b> | Type CF | Type CF | Same | | | | |
| <b>Degree of protection against harmful ingress of water:</b> | Ordinary equipment (Sealed equipment without liquid proof) | Ordinary equipment (Sealed equipment without liquid proof) | Same | | | | |
| <b>Disinfection/sterilization method:</b> | Refer to the user manual for details | Refer to the user manual for details | Same | | | | |
| <b>Degree of safety of application in the presence of flammable gas:</b> | Equipment not suitable for use in the presence of flammable gas | Equipment not suitable for use in the presence of flammable gas | Same | | | | |
| <b>Working mode:</b> | Continuous operation | Continuous operation | Same | | | | |
| <b>EMC:</b> | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same | | | | |
| <b>Ingress rating</b> | IPX0 | IPX0 | Same | | | | |
| <b>Environment Specifications</b> | | | | | | | |
| <b>Temperature</b> | | | | | | | |
| <b>Transport &amp; Storage</b> | -20°C (-4°F) ~ +55°C (+131°F) | -20°C (-4°F) ~ +55°C (+131°F) | Same | | | | |
| <b>Working</b> | +5°C (+41°F) ~ +40°C (+104°F) | +5°C (+41°F) ~ +40°C (+104°F) | Same | | | | |
| <b>Relative Humidity:</b> | | | | | | | |
| <b>Transport &amp; Storage</b> | 25%~93%<br>Non-Condensing | 25%~93%<br>Non-Condensing | Same | | | | |
| <b>Working</b> | 25% RH ~ 80% RH<br>Non-Condensing | 25% RH ~ 80% RH<br>Non-Condensing | Same | | | | |
| <b>Atmospheric Pressure:</b> | | | | | | | |
| <b>Transport &amp; Storage</b> | | 700 hPa ~ 1060 hPa | Operating Voltage = | 700 hPa ~ 1060 hPa | Operating Voltage = | Same | |
| <b>Working</b> | Mains Supply: | 860 hPa ~ 1060 hPa | 100V-240V~ | 860 hPa ~ 1060 hPa | 100V-240V~ | Same | Same |
| Operating frequency = 50 Hz /<br>60 Hz | | Operating frequency = 50 Hz / 60 Hz | Same | | | | |
| Input Power = 70VA | | Input Current = 0.9-0.4A<br>Or Input power = 96VA | Different | | | | |
| | Rated voltage = 14.8 V | Rated voltage = 14.8 V | Same | | | | |
| | SE-12 Express&SE-1200<br>Express: Rated capacity =<br>4400mAh | SE-12 Express&SE-1200<br>Express: Rated capacity =<br>5000mAh | Different | | | | |
| | SE-12& SE-1200: Rated<br>capacity =2200mAh | SE-12& SE-1200: Rated capacity<br>= 2500mAh | | | | | |
| Built-in Lithium<br>Battery Pack: | When the battery is fully<br>charged, SE-12&SE-1200 can<br>work<br>normally about 4 hours, and it<br>can continually print about 1.5<br>hours in the manual mode or<br>print about 300 ECG reports of<br>$3×4+1R$ in the auto mode; SE-12<br>Express &SE-1200 Express can<br>work<br>normally about 5 hours, and it<br>can continually print about 2.5<br>hours in the manual mode or<br>print about 350 ECG reports of<br>$3×4+1R$ in the auto mode. | When the battery is fully<br>charged, SE-12& SE-1200 can<br>work normally about 4 hours, and<br>it can continually print about 1.5<br>hours in the manual mode or<br>print about 300 ECG reports of<br>$3×4+1R$ in the auto mode; SE-12<br>Express& SE-1200 Express can<br>work normally about 5 hours, and<br>it can continually print about 2.5<br>hours in the manual mode or<br>print about 350 ECG reports of<br>$3×4+1R$ in the auto mode. | Same | | | | |
| | Performance Specifications | | | | | | |
| | Recording<br>Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same | | | |
| | | 8 dots per mm / 200 dots per inch<br>(amplitude axes) | 8 dots per mm / 200 dots per inch<br>(amplitude axes) | | | | |
| | Printing Density | 40 dots per mm / 1000 dots per<br>inch (time axes, @ 25 mm/s) | 40 dots per mm / 1000 dots per<br>inch (time axes, @ 25 mm/s) | Same | | | |
| | Recorder Paper: | Folded thermal paper:<br>210mm×295mm×100pages | Folded thermal paper:<br>210mm×295mm×100pages | | | | |
| Folded thermal paper:<br>215mm×280mm×100pages<br>(Optional) | | Folded thermal paper:<br>215mm×280mm×100pages<br>(Optional) | Same | | | | |
| Rolled thermal paper:<br>210mm×30m (Optional) | | Rolled thermal paper:<br>210mm×30m (Optional) | | | | | |
| Effective Width: | | 203 mm | 203mm | Same | | | |

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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<br>(±3%) | 12.5mm/s, 25mm/s, 50mm/s<br>(±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<br>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<br>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<br>(mm/mV) | 2.5, 5, 10, 20, 10/5, AGC<br>(mm/mV) | Same |
| Input Impedance: | ≥50 MΩ(10 Hz) | ≥50 MΩ(10 Hz) | Same |
| Input Circuit<br>Current: | ≤0.01μA | ≤0.01μA | Same |
| Input Voltage<br>Range | ≤±5 mVpp | ≤±5 mVpp | Same |
| Calibration<br>Voltage: | 1 mV±3% | 1 mV±3% | Same |
| DC Offset<br>Voltage: | ±600 mV | ±600 mV | Same |
| Noise: | ≤12.5 µVp-p | ≤12.5 µVp-p | Same |
| Multi-channel<br>Crosstalk | ≤0.5 mm | ≤0.5 mm | Same |
| Filter | AC Filter: On / Off | AC Filter: On / Off | Same |
| | DFT Filter: 0.05Hz / 0.15Hz /<br>0.25Hz / 0.32Hz / 0.5Hz /<br>0.67Hz | DFT Filter: 0.05Hz / 0.15Hz /<br>0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz | Same |
| | EMG Filter: 25Hz / 35Hz / 45Hz<br>/ OFF | EMG Filter: 25Hz / 35Hz / 45Hz<br>/ OFF | Same |
| | LOWPASS Filter: 150Hz /<br>100Hz / 75Hz | LOWPASS Filter: 150Hz / 100Hz<br>/ 75Hz | Same |
| | CMRR | ≥115 dB | ≥115 dB |
| | Sampling<br>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<br>Frequency | 10,000/sec/channel | 10,000/sec/channel | Same |
| External Input/ Output | | | |
| Input | ≥100 kΩ; Sensitivity 10<br>mm/V±5%;<br>Single ended | ≥100 kΩ; Sensitivity 10<br>mm/V±5%;<br>Single ended | Same |
| Output | ≤100Ω; Sensitivity 1 V/mV ±5%;<br>Single ended | ≤100Ω; Sensitivity 1 V/mV ±5%;<br>Single ended | Same |

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

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