Electrocardiograph

K171942 · Edan Instruments, Inc. · DPS · Jan 24, 2018 · Cardiovascular

Device Facts

• Record ID: K171942
• Device Name: Electrocardiograph
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jan 24, 2018
• Decision: SESE
• Submission Type: Special
• 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 (beginning at birth through 21 years of age) 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 simultaneously from adult and pediatric patients. The device features a 32-bit processor, high-resolution thermal recorder, and internal memory. It operates via mains or battery power. The system offers manual, auto, rhythm, R-R analysis, and VCG (on Express models) modes. SE-12 Express includes stress ECG functionality for diagnosing coronary heart disease and assessing treatment effects. Used in hospitals/clinics by physicians and trained healthcare professionals. The device displays ECG waveforms and parameters on an integrated LCD screen. It provides automated measurements and interpretive statements as an advisory tool for clinicians to support heart disease diagnosis. The device is intended to aid clinical decision-making, not replace professional judgment.

Clinical Evidence

No clinical data. Evidence consists of bench testing per IEC 60601-2-25:2011, biocompatibility testing (cytotoxicity, skin sensitization, skin irritation per ISO 10993-1), electrical safety/EMC testing (IEC 60601-1, IEC 60601-1-2), and software verification/validation.

Technological Characteristics

12-lead ECG system; 24-bit A/D resolution; 16,000 Hz sampling frequency; thermal dot-matrix recorder (200 dpi amplitude, 1000 dpi time axis); LCD display (320x240 or 800x600); Type CF applied part; Class I with internal battery; connectivity via mains/battery; software-based interpretation; biocompatible materials (surface contact <24h).

Indications for Use

Indicated for adult and pediatric patients (birth through 21 years) for the acquisition of ECG signals via body surface electrodes to assist in 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 Instruments, Inc., Electrocardiograph, models SE-12, SE-12 Express, SE-1200, and SE-1200 Express (K160876)

Reference Devices

• Edan Instruments, Inc., PC ECG, model SE-1515 (K152427)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 24, 2018

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

Re: K171942

Trade/Device Name: Electrocardiograph with 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: December 21, 2017 Received: December 26, 2017

Dear Doug Worth:

We have reviewed vour 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-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

MA Willel em

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

# K171942

#### Device Name

Electrocardiograph: SE-12, SE-12 Express, SE-1200, 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 (beginning at birth through 21 years of age) through body surface ECG 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 disease. However, the interreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Type of Use (Select one or both, as applicable)

X 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 requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc.<br>#15 Jinhui Road, Jinsha Community,<br>Kengzi Sub-District, Pingshan District, Shenzhen, 518122 P.R.China.<br>Tel.: [phone]<br>Fax: [phone] |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alice Yang |
| Date prepared: | June 19, 2017 |
| 2. Device name<br>and classification: | Device Name: Electrocardiograph |
| | Model: SE-12, SE-1200, SE-12 Express, SE-1200 Express |
| | Classification Name: |
| | 870.2340 Electrocardiograph<br>Product code: DPS |
| | Regulatory Class: Class II |
| 3.Premarket<br>Notification Class<br>III Certification<br>and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate<br>Device(s): | 1. Edan Instruments, Inc., Electrocardiograph, models SE-12, SE-12 Express,<br>SE-1200, and SE-1200 Express cleared under K160876 (Primary)<br>2. Edan Instruments, Inc., PC ECG, model SE-1515 cleared under<br>K152427(Reference) |
| 5. Reason for<br>Submission | Modification for previous cleared product Electrocardiograph, models<br>SE-12, SE-1200, SE-12 Express, SE-1200 Express. |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. |

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| 7. Device<br>Description: | The SE-12/12 Express/1200/1200 Express Electrocardiograph gathers<br>ECG signals of 12 leads simultaneously. It displays the operation menu,<br>ECG parameters as well as electrocardiograms, and be powered by the<br>mains supply or battery. And the system has advanced performance and<br>high reliability due to high resolution thermal recorder, 32-bit processor<br>and a large-capacity memorizer. Design of the system took much<br>consideration on ergonomics so the size is suitable for clinic and<br>hospital uses. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | There are four selectable modes in the system, including manual, auto,<br>rhythm, R-R analysis or VCG, and VCG is configured with SE-12<br>Express & SE-1200 Express. |
| | SE-12 and SE-1200 share the same single-color LCD screen of which<br>the resolution is 320×240 dot; and LCD screen of SE-12 Express and<br>SE-1200 Express is 800×600 multicolor LCD screen. |
| | Moreover, SE-12 Express is configured with stress ECG function, which<br>will allow to diagnose concealed coronary heart disease and atypical<br>angina pectoris, prescribe the workload for patients with myocardial<br>infarction before leaving hospital, and assess the effect of the treatment. |
| 8. Intended Use: | The intended use of SE-12 series electrocardiograph is to acquire ECG<br>signals from adult and pediatric patients (beginning at birth through 21<br>years of age) through body surface ECG electrodes. The<br>electrocardiograph is only intended to be used in hospitals or healthcare<br>facilities by doctors and trained healthcare professionals. The<br>cardiogram recorded by the electrocardiograph can help users to analyze<br>and diagnose heart disease. However, the interpreted ECG with<br>measurements and interpretive statements is offered to clinicians on an<br>advisory basis only. |

# 9. Predicate Device Comparison

Comparison to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following tables:

| Item | Predicatedevice<br>(SE-12, SE-12Express,<br>SE-1200, andSE-1200Express) | Proposed device<br>(SE-12, SE-12Express, SE-1200,<br>andSE-1200Express) | Comparison<br>Result |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K160876 | 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 | The intended use of SE-12 series<br>electrocardiograph is to acquire<br>ECG signals from adult and<br>pediatric patient (beginning at<br>birth through 21 years of age)<br>through body surface ECG<br>electrodes. The | Different |
| | | | |
| 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. | | 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. | |
| 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/EN 60601-2-25 | 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/EN 60601-2-25 | Same |
| 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%<br>Non-Condensing | 25%~93%<br>Non-Condensing | Same |
| Working | 25% RH ~ 80% RH<br>Non-Condensing | 25% RH ~ 80% RH<br>Non-Condensing | Same |
| Atmospheric Pressure: | | | |
| Transport & Storage | 700 hPa ~1060 hPa | 700 hPa ~1060 hPa | Same |
| Working | 860 hPa ~1060 hPa | 860 hPa ~1060 hPa | Same |
| Power Supply Specifications | | | |

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| Operating frequency = 50 Hz / 60<br>Operating frequency = 50 Hz / 60<br>Same<br>Hz<br>Hz<br>Mains Supply:<br>Input Current = 0.9-0.4A<br>Input Current = 0.9-0.4A<br>Same<br>Or Input power = 96VA<br>Or Input power = 96VA<br>Rated voltage = 14.8 V<br>Rated voltage = 14.8 V<br>Same<br>SE-12 Express&SE-1200<br>SE-12 Express&SE-1200<br>Express: Rated capacity =<br>Express: Rated capacity =<br>5000mAh<br>5000mAh<br>Same<br>SE-12& SE-1200: Rated capacity<br>SE-12& SE-1200: Rated capacity<br>= 2500mAh<br>= 2500mAh<br>When the battery is fully<br>When the battery is fully charged,<br>charged, SE-12&SE-1200 can<br>work<br>SE-12& SE-1200can work<br>normally about4hours, and it can<br>normally about 4 hours, and it<br>Built-in Lithium<br>can continually print about 1.5<br>continually print about 1.5 hours<br>Battery Pack:<br>hours in the manual mode or<br>in the manual mode or print<br>print about 300 ECG reports of<br>about300 ECG reports of<br>3×4+1R in the auto mode: SE-12<br>3×4+1Rin the auto mode; SE-12<br>Same<br>Express &SE-1200 Express can<br>Express& SE-1200 Express can<br>work normally about 5 hours, and<br>work<br>it can continually print about 2.5<br>normally about 5 hours, and it<br>can continually print about 2.5<br>hours in the manual mode or print<br>hours in the manual mode or<br>about 350 ECG reports of<br>print about 350 ECG reports of<br>3×4+1Rin the auto mode.<br>3×4+1R in the auto mode.<br>Performance Specifications<br>Recording<br>Thermal dot-matrix recorder<br>Thermal dot-matrix recorder<br>Recorder:<br>Same<br>8 dots per mm / 200 dots per inch<br>8 dots per mm / 200 dots per inch<br>(amplitude axes)<br>(amplitude axes)<br>Printing Density<br>Same<br>40 dots per mm / 1000 dots per<br>40 dots per mm / 1000 dots per<br>inch (time axes, @, 25 mm/s)<br>inch (time axes, (@, 25 mm/s)<br>Folded thermal paper:<br>Folded thermal paper:<br>210mm×295mm×100pages<br>210mm×295mm×100pages<br>Folded thermal paper:<br>Folded thermal paper:<br>Recorder Paper:<br>215mm×280mm×100pages<br>215mm×280mm×100pages<br>Same<br>(Optional)<br>(Optional)<br>Rolled thermal paper:<br>Rolled thermal paper:<br>210mm×30m (Optional)<br>210mm×30m (Optional)<br>Effective Width:<br>210mm<br>210mm<br>Same<br>5mm/s, 6.25mm/s, 10mm/s,<br>5mm/s, 6.25mm/s, 10mm/s,<br>12.5mm/s, 25mm/s, 50mm/s<br>12.5mm/s, 25mm/s, 50mm/s<br>Paper Speed:<br>Same<br>(+3%)<br>(+3%)<br>±5% (x-axis), ±5%(y-axis)<br>Accuracy of data:<br>±5% (x-axis), ±5%(y-axis)<br>Same | | Operating Voltage =100V-240V~ | Operating Voltage =100V-240V~ | Same | |
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