Electrocardiograph

K170995 · Edan Instruments, Inc. · DPS · Jun 2, 2017 · Cardiovascular

Device Facts

• Record ID: K170995
• Device Name: Electrocardiograph
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SE-18 18-lead electrocardiograph is intended 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-18 is an 18-lead electrocardiograph used in hospitals and healthcare facilities by trained professionals. It acquires ECG signals via body surface electrodes; processes signals using digital filters (anti-baseline drift, AC, EMG, low pass) and the Smart ECG Measurement and Interpretation Program (SEMIP); and displays waveforms on a 15-inch screen. The device includes an external sampling box, main control board, thermal printer, and connectivity modules (Ethernet, Wi-Fi, USB). Recorded ECGs can be stored in flash memory or transmitted to a PC. The SEMIP program provides automated measurements and interpretive statements to clinicians on an advisory basis to aid in heart disease diagnosis. The device does not deliver substances to or extract substances from the patient.

Clinical Evidence

No clinical data. Substantial equivalence is supported by 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.

Technological Characteristics

18-lead ECG system; 15-inch 1024x768 display; thermal printer (216mm width); 24-bit A/D conversion; 16kHz sampling frequency; Ethernet/Wi-Fi/USB connectivity. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25. Biocompatibility per ISO 10993-1. Software: SEMIP algorithm for measurement/interpretation.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition via body surface electrodes for heart disease analysis and diagnosis by healthcare professionals.

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, Inc. Electrocardiograph, models SE-1515 (K152427)
• EDAN Instrument, Inc. Electrocardiograph, models SE-12, SE-12 Express, SE-1200, and SE-1200 Express (K160876)

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 a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

June 2, 2017

Edan Instruments, Inc. Mr. Doug Worth Sr. Dir. US RA/OA 1200 Crossman Ave, Suite 200 Sunnyvale, California 94086

Re: K170995

Trade/Device Name: SE-18 Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 30, 2017 Received: April 3, 2017

Dear Mr. 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 (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 [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.

Sincerelv.

M.A. Hillemann

for.

for __________________________________________________________________________________________________________________________________________________________________________ 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 know n)

### K170995

Device Name SE-18 Electrocardiograph

### Indications for Use (Describe)

The SE-18 18-lead electrocardiograph is intended to acquire ECG signals fromadult and pediatric patients through body surface ECG electrodes. The electrocardiographis only intended o be used in hospitals or healthcare healthcare professionals. The cardiogramrecorded by the electrocardio graph 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.

| Type of Use (Select one or both, as applicable) | <div> <span> <span style="padding-right:5px;"> <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" src="checkbox_checked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> </span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> <div> <span> <span style="padding-right:5px;"> <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:15px; height:15px; vertical-align:middle;"/> </div> </span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </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>#15 Jinhui Road,Jinsha Community,<br>Kengzi Sub-District, Pingshan District,<br>Shenzhen, 518122 P.R.China.<br>518067 P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:<br>Preparing date: | Alice Yang<br>March 30, 2017 |
| 2. Device name and<br>classification: | Device Name: Electrocardiograph<br>Model: SE-18<br>Classification Name/ Product code:<br>870.2340 Electrocardiograph/DPS<br>Regulatory Class: Class II |
| 3. Predicate Device(s): | 1. EDAN Instrument, Inc. Electrocardiograph, models SE-1515,<br>K152427 (Primary)<br>2. EDAN Instrument, Inc. Electrocardiograph, models SE-12, SE-12<br>Express, SE-1200, and SE-1200 Express, K160876 (Reference) |
| 4. Reason for<br>Submission | New model |
| 5. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. |
| 6. Device Description: | The SE-18 acquires and displays an 18 leads waveforms, which can<br>also be printed by an integrated thermal printer with effective<br>recording width 216mm. |
| | Digital filtering techniques similar to those incorporated on the<br>SE-1515 and SE-12 have been used in SE-18: including |

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Anti-baseline drift filter, AC filter (50/60Hz), EMG Filter and Low pass Filter, which can help the user to record a higher quality ECG. The EDAN Instruments "Smart ECG Measurement and interpretation program" (SEMIP) is included in this machine. The SEMIP program is completely integrated and provides the clinician with a detailed analysis of the ECG signal to aid in the interpretation of the ECGs. The recorded ECG can be saved in flash memory or sent to a PC by Ethernet or WIFI. During the examination, there are no substances delivered to and/or extracted from the patient. SE-18'sfunction block diagram is shown as Fig 1.It's made up of an external ECG Sampling Box, SE-18 Main Control Board with RAM, FLASH, Ethernet module, WIFI module and USB module, a thermal printer module, a power supply module, a keyboard, and 15' 1024*768 display module. The SE-18 18-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG

7. Intended Use: 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 | Proposed device<br>(SE-18) | Predicate device<br>(SE-1515) | Remark | |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------|
| 510(k) Number | Current Submission | K152427 | ---- | |
| Indications for Use | | | | |
| Intended use | The SE-18 18-lead<br>electrocardiograph is intended<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<br>hospitals or healthcare<br>facilities by doctors and<br>trained healthcare<br>professionals. The cardiogram<br>recorded by the<br>electrocardiograph can help<br>users to analyze and diagnose<br>heart disease. However, the<br>interpreted ECG with<br>measurements and<br>interpretive statements is<br>offered to clinicians on an<br>advisory basis only. | SE-1515 PC ECG is intended to<br>acquire, process and store ECG<br>signals from adult and pediatric<br>patients undergoing stress<br>exercise test or resting test. The<br>SE-1515 PC ECG is intended to<br>be used only in hospitals and<br>healthcare facilities by doctors<br>and trained healthcare<br>professionals. The cardiogram<br>recorded by the SE-1515 PC<br>ECG can help users to analyze<br>and diagnose heart diseases.<br>However, the ECG with<br>measurements and interpretive<br>statements is offered to clinicians<br>on an advisory basis only. | Differen<br>t | |
| SW Algorithm | SEMIP | SEMIP | Same | |
| Sampling Box | DE18 | DE18/DE15/DX12/DP12 | Differen<br>t | |
| Safety Specifications | | | | |
| Safety Standards | IEC 60601-1:2005/A1:2012<br>EN 60601-1:2006/A1:2013<br>IEC 60601-1-2:2007<br>EN 60601-1-2:2007/AC:2010<br>IEC 60601-2-25:2011 | IEC 60601-1:2005/A1:2012<br>EN 60601-1:2006/A1:2013<br>IEC 60601-1-2:2007<br>EN 60601-1-2:2007/AC:2010<br>IEC 60601-2-25:2011 | Same | |
| Anti-electric-shock<br>type: | Class I with internal power<br>supply | Class II | Differen<br>t | |
| Anti-electric-shock<br>degree: | Type CF with<br>defibrillation-proof | Type CF with defibrillation-proof | Same | |
| Degree of protection<br>against harmful ingress<br>of water: | Ordinary equipment (Sealed<br>equipment without liquid<br>proof) | Ordinary equipment (Sealed<br>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 | |
| Patient Leakage Current: | NC<br>SFC | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | Same |
| Patient Auxiliary Current: | NC<br>SFC | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | $<10μA (AC) / <10μA (DC)<50μA (AC) / <50μA (DC)$ | Same |
| Environmental Specifications | | | | |
| Temperature | | | | |
| Operating | +5°C (+41°F) ~ +40°C (+104°F) | +5°C (+41°F) ~ +40°C (+104°F) | Same | |
| Transport/Storage | -20°C (-4°F) ~ +55°C (+131°F) | -20°C (-4°F) ~ +55°C (+131°F) | Same | |
| Humidity | | | | |
| Operating | 15%RH~95%RH<br>Non-Condensing | 25% RH~80% RH<br>Non-Condensing | Different | |
| Transport/Storage | 15%RH~95%RH<br>Non-Condensing | 25% RH~93% RH<br>Non-Condensing | t | |
| Pressure | | | | |
| Operating | 70 kPa ~106 kPa | 86 kPa ~106 kPa | Different | |
| Transport/Storage | 70 kPa ~106 kPa | 70 kPa ~106 kPa | t | |
| Performance Specifications | | | | |
| HR Recognition | | | | |
| HR Range: | 30 bpm ~300 bpm | 30 bpm ~300 bpm | Same | |
| Accuracy: | $\pm$ 1 bpm | $\pm$ 1 bpm | Same | |
| ECG Unit (only DE18 is listed for SE-1515) | | | | |
| Leads: | 18 standard leads | 18 standard leads | Same | |
| Acquisition Mode: | 18 leads acquisition<br>simultaneously | 18 leads acquisition<br>simultaneously | Same | |
| Sampling Frequency | 16kHz | 16kHz | Same | |
| A/D: | 24bits | 24 bits | Same | |
| Resolution: | 0.1575 μV/LSB | 0.1575uV/LSB | Same | |
| Time Constant: | ≥3.2s | ≥3.2s | Same | |
| Frequency Response: | 0.01~300Hz(-3dB) | 0.01~300Hz(-3dB) | 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: | ≥100M Ω (10Hz) | ≥100MΩ (10Hz) | Same | |
| Input Circuit Current: | ≤0.01μA | ≤0.01μA | Same | |
| Input Voltage Range | ≤±5 mVpp | ≤±5 mVpp | Same | |
| Calibration Voltage: | 1mV±2% | 1mV ± 2% | Same | |
| DC Offset Voltage: | ±600mV | ±600mV | Same | |
| Minimum Amplitude: | 20 μVp-p | 20 μVp-p | Same | |
| Noise: | ≤12.5μVp-p | ≤12.5μVp-p | Same | |
| Multichannel crosstalk | ≤0.5mm | ≤0.5mm | Same | |
| Filter | AC | 50Hz/60Hz/Off | 50Hz/60Hz/Off | Same |
| | DFT | 0.01Hz/0.05Hz/0.32Hz/0.67Hz | 0.01Hz/0.05Hz/0.32Hz/0.67Hz | |
| | EMG | 25Hz/35Hz/45Hz/Off | 25Hz/35Hz/45Hz/Off | |
| | LOWPASS Filter | 300Hz/270Hz/150Hz/<br>100Hz/75Hz | 300Hz/270Hz/150Hz/100Hz/75Hz | |
| | |…