Electrocardiograph

K212278 · Edan Instruments, Inc. · DPS · Apr 7, 2022 · Cardiovascular

Device Facts

• Record ID: K212278
• Device Name: Electrocardiograph
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The iSE series 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. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.

Device Story

The iSE series (iSE-1210, iSE-1810) are electrocardiographs acquiring ECG signals via body surface electrodes (up to 12 or 18 leads). Used in hospitals/clinics by physicians and trained professionals; device performs signal processing to generate measurements, graphical presentations, and interpretive statements. Output is provided to clinicians on an advisory basis to assist in heart disease diagnosis. Device supports network communications (WiFi, Bluetooth, 4G, NFC) for workflow management. Benefits include automated ECG analysis and streamlined clinical data management.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, electrical safety (ANSI AAMI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance testing (IEC 60601-2-25), human factors/usability engineering (IEC 62366-1), and software verification and validation.

Technological Characteristics

Electrocardiograph supporting 12-lead (iSE-1210) or 18-lead (iSE-1810) acquisition. Features 24-bit A/D conversion, 64,000 Hz sampling frequency, and 0.01-350 Hz frequency response. Includes thermal dot-matrix recorder, lithium battery, and wireless connectivity (WiFi, Bluetooth, 4G, NFC). Software utilizes SEMIP V1.92 algorithm. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition via body surface electrodes 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 Instruments, SE-18 Electrocardiograph (K170995)

Reference Devices

• Edan Instruments, SE-12 Electrocardiograph (K171942)
• Edan Instruments, SE-12 Express Electrocardiograph (K171942)
• Edan Instruments, SE-1200 Electrocardiograph (K171942)
• Edan Instruments, SE-1200 Express Electrocardiograph (K171942)

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 and Human Services logo. To the right of that 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.

April 7, 2022

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

Re: K212278

Trade/Device Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: February 28, 2022 Received: March 7, 2022

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 mediation-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.

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)

Device Name Electrocardiograph

Indications for Use (Describe)

The iSE series 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. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.

| 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, Kengzi Sub-District, Pingshan District,<br>Shenzhen, 518122 P.R.China.<br>Tel: [phone] |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:<br>Preparing date: | Joan. Wei<br>June 25th, 2021 |
| 2. Device name and<br>classification: | Electrocardiograph<br>Classification Name/ Product code: |
| | 21 CFR 870.2340 Electrocardiograph, DPS<br>Regulatory Class: Class II |
| 3.Premarket Notification<br>Class III Certification<br>and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Edan Instruments, SE-18 Electrocardiograph, cleared under K170995<br>(Primary)<br>2) Edan Instruments, SE-12, SE-12 Express, SE-1200, and SE-1200 Express<br>Electrocardiograph, cleared under K171942(Reference) |
| 5. Reason for<br>Submission | By submission of the Traditional 510(k), Edan Instruments is requesting<br>clearance for new devices iSE-1210 and iSE-1810 Electrocardiograph. |
| 6.Pre-Submission,<br>IDE | Not applicable, there is no pre-submission. |
| 7. Device Description: | iSE-1210 and iSE-1810 Electrocardiograph can support ECG Data Sampling of<br>maximum 12 leads and maximum 18 leads separately. iSE series<br>electrocardiograph uses algorithm to generate measurements, data presentations,<br>graphical presentations and interpretative statements. The electrocardiograph is<br>only intended to be used in hospitals or healthcare facilities by doctors and<br>trained healthcare professionals. |

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- 8. Indication for Use The iSE series 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. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.
### 9. Predicate Device Comparison

Comparison to the predicate and reference 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-18) | Proposed device<br>(iSE Series) | Comparison<br>Result | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------|
| K# | K170995 | K212278 | — | |
| Indications for Use/<br>Intended Use | The SE-18 18-lead electrocardiograph is<br>intended to acquire ECG signals from<br>adult and pediatric patients through body<br>surface ECG electrodes. The<br>electrocardiograph is only intended to be<br>used in hospitals or healthcare facilities<br>by doctors and trained healthcare<br>professionals. The cardiogram recorded<br>by the electrocardiograph can help users<br>to analyze and diagnose heart disease.<br>However, the interpreted ECG with<br>measurements and interpretive statements<br>is offered to clinicians on an advisory<br>basis only. | The iSE Series electrocardiograph is<br>intended to acquire ECG signals from<br>adult and pediatric patients through<br>body surface ECG electrodes. The<br>electrocardiograph is only intended to<br>be used in hospitals or healthcare<br>facilities by doctors and trained<br>healthcare professionals. The<br>cardiogram recorded by the<br>electrocardiograph can help users to<br>analyze and diagnose heart disease.<br>However, the interpreted ECG with<br>measurements and interpretive<br>statements is offered to clinicians on an<br>advisory basis only. The<br>electrocardiograph is capable of<br>network communications and supports<br>the informatized management of | Different | |
| | | workflows in hospital and healthcare<br>facilities. | | |
| Algorithm | SEMIP V1.8 | SEMIP V1.92 | Different | |
| The number of<br>electrodes | 16 | iSE-1810: 16<br>iSE-1210: 10 | Different | |
| Power Supply Specifications | | | | |
| Mains Supply: | Operating Voltage = 100V-240V~<br>Operating Frequency = 50Hz/60Hz<br>Input Current = 0.9A ~ 0.4A | Operating Voltage = 100V-240V~<br>Operating frequency=50Hz/60Hz<br>Input current=1.1 A | Same<br>Same<br>Different | |
| Lithium Battery Pack: | Rated voltage = 14.8 V<br>Rated capacity = 5000mAh<br>-- | Rated voltage = 15.2 V<br>Rated capacity = 3550mAh<br>When the battery is fully charged, iSE can work (without printing) continuously at least 8 hours.<br>100% recharge time: ≤ 5 hours<br>90% recharge time: < 4 hours | Different | |
| Performance Specifications | | | | |
| Recording (Optional for iSE with thermal printer) | | | | |
| Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same | |
| HR Recognition | HR Range | 30 BPM ~ 300 BPM | 30 BPM ~ 300 BPM | Same |
| ECG Unit | Leads: | iSE-1810: 9, 12, 15, 16 or 18 standard leads<br>iSE-1210: 9 or 12 standard leads | Different | |
| | A/D | 24 bits | 24 bits | Same |
| | Sampling Frequency | 16, 000 Hz | 64,000 Hz | Different |
| | Frequency<br>Response: | 0.01Hz~300Hz (-3 dB) | 0.01 Hz ~ 350 Hz (-3 dB) | Different |
| Filter | AC Filter | AC Filter | Same | |
| | DFT Filter | DFT Filter | Same | |
| | EMG Filter | EMG Filter | Same | |
| | LOWPASS Filter:<br>300Hz/270Hz/150Hz/100Hz/75Hz | LOWPASS Filter:<br>350Hz/300Hz/270Hz/150Hz/100Hz/75 Hz | Different | |
| Pacemaker Detection | | | | |
| | Sampling Frequency | iSE-1810(DE18): 16,000Hz, Rhythm Lead<br>iSE-1210(DE12): 80,000Hz, Rhythm Lead | Different | |
| Connection | | | | |
| Wireless connection | WiFi | WiFi, Bluetooth, 4G, NFC | Different | |
| Item | Reference device<br>(SE-12, SE-12 Express, SE-1200, and<br>SE-1200 Express) | Proposed device<br>(iSE Series) | Comparison<br>Result | |
| K# | K171942 | K212278 | — | |
| Indications for Use/<br>Intended Use | The intended use of SE-12 series<br>electrocardiograph is to acquire ECG<br>signals from adult and pediatric patients<br>through body surface ECG electrodes.<br>The electrocardiograph is only intended to<br>be used in hospitals or healthcare facilities<br>by doctors and trained healthcare<br>professionals. The cardiogram recorded<br>by the electrocardiograph can help users<br>to analyze and diagnose heart disease.<br>However, the interpreted ECG with<br>measurements and interpretive statements<br>is offered to clinicians on an advisory<br>basis only. | The iSE Series electrocardiograph is<br>intended to acquire ECG signals from<br>adult and pediatric patients through<br>body surface ECG electrodes. The<br>electrocardiograph is only intended to<br>be used in hospitals or healthcare<br>facilities by doctors and trained<br>healthcare professionals. The<br>cardiogram recorded by the<br>electrocardiograph can help users to<br>analyze and diagnose heart disease.<br>However, the interpreted ECG with<br>measurements and interpretive<br>statements is offered to clinicians on an<br>advisory basis only. The<br>electrocardiograph is capable of<br>network communications and supports<br>the informatized management of<br>workflows in hospital and healthcare<br>facilities. | Different | |
| The number of<br>electrodes | 10 | iSE-1210: 10 | Same | |
| Leads: | Standard 12 leads | iSE-1210: 9 or 12 standard leads | Different | |

### Table 1: Comparison between iSE Series and SE-18

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# Table 2: Comparison between iSE Series and SE-12 Series

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

## 10. Performance Data:

### Non-clinical data:

### Electrical safety and electromagnetic compatibility (EMC)

The iSE series electrocardiograph were assessed for conformity with the relevant requirements of the following standards:

- 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.

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### Performance testing-Bench

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
### Human Factors Engineering Testing

Edan has conducted usability testing to validate the usability of the devices. The results of usability testing show that the subject device safe and effective for the intended users, uses, and use environments and meet the requirement of following FDA s are Guidance and consensus standard:

- Applying Human Factors and Usability Engineering to Medical Devices, issued on February 3, 2016
- IEC 62366-1:2020 Medical Devices-Part 1:Application of usability engineering to medical devices

### 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 predicate devices.

#### 11. Conclusion

The non-clinical data, bench testing data, and software verification testing demonstrate that iSE series electrocardiograph are substantially equivalent to the predicate devices.