electrocardiograph: SE-1202

K210140 · Edan Instruments, Inc. · DPS · Oct 1, 2021 · Cardiovascular

Device Facts

• Record ID: K210140
• Device Name: electrocardiograph: SE-1202
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SE-1202 12-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-1202 is a 12-lead electrocardiograph featuring a 10.1" LCD touch screen and thermal printer; used in hospitals/healthcare facilities by clinicians. It acquires ECG signals via body surface electrodes; processes data using SEMIP or Glasgow algorithms to generate measurements, graphical presentations, and interpretive statements. The device operates on AC or battery power; saves records to internal flash memory or transmits to a PC. Output is provided to clinicians on an advisory basis to assist in heart disease diagnosis and analysis. The device benefits patients by providing automated ECG analysis to support clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via EDAN proprietary database and testing against consensus standards including IEC 60601-2-25, ANSI AAMI ES 60601-1, and IEC 60601-1-2.

Technological Characteristics

12-lead electrocardiograph with 10.1" LCD touch screen; 1GHz CPU; 64,000 Hz sampling frequency. Connectivity via Wi-Fi. Powered by AC or 14.8V lithium battery. Thermal dot-matrix recorder. Complies with ANSI AAMI ES 60601-1 and IEC 60601-1-2. Software includes SEMIP or Glasgow algorithms for automated interpretation.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition via body surface electrodes. Contraindicated for neonatal patients (birth to 28 days) regarding SEMIP algorithm interpretive statements.

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: SE-12, SE-12 Express, SE-1200, and SE-1200 Express (K171942)

Submission Summary (Full Text)

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October 1, 2021

Edan Instruments, Inc Ying Dai Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China

Re: K210140

Trade/Device Name: Electrocardiograph: SE-1202 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DYC Dated: July 15, 2021 Received: July 20, 2021

Dear Ying Dai:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210140

Device Name Electrocardiograph(SE-1202)

### Indications for Use (Describe)

The SE-1202 12-lead electrocardiograph is intended 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.

#### CONTRAINDICATIONS:

SEMIP algorithm is not intended for interpretive statements of neonatal patients from birth to 28 days.

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 content and format regulatory requirements of 21 CFR Part 807.92

| <b>1. Submitter:</b> | Edan Instruments, Inc.<br>#15 Jinhui Road, Jinsha Community,<br>Kengzi Sub-District, Pingshan District,<br>Shenzhen, 518122 P.R.China.<br>Tel: [phone]<br>Fax: [phone] | | | | | | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------|------------------------------------|-----|-----------------------------------|-----|
| <b>Contact person:</b> | Ying DAI | | | | | | |
| <b>Preparing date:</b> | January 15, 2021 | | | | | | |
| <b>2. Device name and classification:</b> | Trade Name: Electrocardiograph, model: SE-1202 | | | | | | |
| | Common/Usual Name: Electrocardiograph | | | | | | |
| | <table><tr><th>Classification Name</th><th>Product code</th></tr><tr><td>21 CFR 870.2340 Electrocardiograph</td><td>DPS</td></tr><tr><td>21 CFR 870.2400 Vectorcardiograph</td><td>DYC</td></tr></table> | Classification Name | Product code | 21 CFR 870.2340 Electrocardiograph | DPS | 21 CFR 870.2400 Vectorcardiograph | DYC |
| Classification Name | Product code | | | | | | |
| 21 CFR 870.2340 Electrocardiograph | DPS | | | | | | |
| 21 CFR 870.2400 Vectorcardiograph | DYC | | | | | | |
| | Regulatory Class: Class II | | | | | | |
| <b>3. Predicate Device(s):</b> | Edan Instruments, Inc, Electrocardiograph: SE-12, SE-12 Express, SE-1200, and SE-1200 Express, K171942. | | | | | | |
| <b>4. Device Description:</b> | The SE-1202 electrocardiograph features a 10.1" LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC. | | | | | | |
| <b>5. Indication for Use</b> | The SE-1202 12-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. | | | | | | |
| | CONTRAINDICATIONS: | | | | | | |
| | SEMIP algorithm is not intended for interpretive statements of neonatal patients | | | | | | |

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from birth to 28 days.

## 6. 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 | Predicate device<br>(SE-12, SE-12 Express, SE-1200,<br>and SE-1200 Express) | Proposed device<br>(SE-1202) | Comparison<br>Result |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K171942 | K210140 | — |
| Intended Use | 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 and<br>trained healthcare professionals.<br>The cardiogram 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. | The SE-1202 12-lead<br>electrocardiograph is intended 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<br>or 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 |
| ECG functionality | Resting ECG, Exercise ECG | Resting ECG | Different |
| Algorithm | SEMIP or Glasgow | SEMIP or Glasgow | Same |
| The number of<br>electrodes | 10 | 10 | Same |
| Mains Supply: | Operating Voltage = 100V-240V~<br>Operating frequency = 50 Hz / 60<br>Hz | Operating Voltage = 100V-240V~<br>Operating frequency = 50 Hz / 60<br>Hz | Same |
| | Input Current = 0.9-0.4A<br>Or Input power = 96VA | Input Current = 0.9-0.4A<br>Or Input power = 96VA | Same |
| | Rated voltage = 14.8 V | Rated voltage = 14.8 V | Same |
| Built-in Lithium Battery<br>Pack: | Rated capacity = 5000mAh or<br>2500mAh | Rated capacity = 5000mAh or<br>2500mAh | Same |
| Performance Specifications | | | |
| Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same |
| HR Range: | 30 BPM ~ 300 BPM | 30 BPM ~ 300 BPM | Same |
| ECG Unit | | | |
| Leads: | Standard 12 leads | 9 or 12 standard leads | |
| Acquisition Mode: | Simultaneously 12 leads | 9 or 12 leads acquisition<br>simultaneously | Different |
| Processor Board | 800 MHz CPU | 1GHz CPU | |
| Sampling Frequency | 16, 000 Hz | 64,000 Hz | Different |
| Input Impedance: | ≥100 MΩ(10 Hz) | ≥100 MΩ(10 Hz) | Same |
| DC Offset Voltage: | ±600 mV | ±900 mV | Different |
| Noise: | ≤12.5 µVp-p | ≤12.5 µVp-p | Same |
| Filter | AC Filter | AC Filter | Same |
| | DFT Filter:<br>0.01Hz/0.05Hz/0.15Hz/0.25Hz/<br>0.32Hz/0.5Hz/0.67Hz | DFT Filter:<br>0.01 Hz / 0.05 Hz / 0.32 Hz / 0.67 Hz | Different |
| | EMG Filter | EMG Filter | Same |
| | LOWPASS Filter:<br>300Hz/270Hz/150Hz/100Hz/75Hz | LOWPASS Filter:<br>350 Hz / 300 Hz / 270 Hz / 150 Hz / 100 Hz / 75 Hz | Different |
| Pacemaker Detection | | | |
| Sampling Frequency | 16,000/sec/channel | 80,000 /sec/channel, Rhythm Lead | Different |
| Connection | | | |
| Wireless connection | Wi-Fi | Wi-Fi | same |

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

# 7. Performance Data:

### Non-clinical data:

### Electrical safety and electromagnetic compatibility (EMC)

The SE-1202 electrocardiograph were assessed for conformity with the relevant requirements of the following standards and found to comply:

- ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.

### Performance testing-Bench

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Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.

- IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- Performance validation via EDAN proprietary database

### 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".

### Clinical data: Not applicable.

### Summary

The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.

### 8. Conclusion

The bench testing data and software verification and validation demonstrate that Electrocardiograph SE-1202 is substantially equivalent to the predicate devices.