PC ECG

K161302 · Edan Instruments, Inc. · DPS · Jul 1, 2016 · Cardiovascular

Device Facts

• Record ID: K161302
• Device Name: PC ECG
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jul 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG 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. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.

Device Story

PADECG is an iPad-based ECG workstation consisting of a DX12(iOS) transmitter and analysis software. The transmitter connects to body surface electrodes, collects 12-lead resting ECG signals, and transmits data via Bluetooth to an iPad. The software displays waveforms, performs automated analysis, and provides advisory diagnostic results. Used in hospital inpatient departments by physicians and trained healthcare professionals. Clinicians review the advisory measurements and interpretive statements to assist in diagnosing heart disease. The system facilitates ECG data acquisition, storage, and analysis, supporting clinical decision-making through automated interpretation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance testing (IEC 60601-2-25), and software verification/validation. ECG interpretation features were validated using database testing.

Technological Characteristics

12-lead ECG system; DX12(iOS) transmitter; iPad-based analysis software. Connectivity: Bluetooth (2402-2480Hz). Sampling rate: 10,000/sec/channel. Resolution: 2.52uV/LSB. Frequency response: 0.05-150Hz. Input impedance: ≥20MΩ. Safety: Class II, Type CF defibrillation-proof. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-1-6, EN ISO 14971. Software: SEMIP v1.8 algorithm.

Indications for Use

Indicated for adult and pediatric patients requiring resting ECG signal acquisition via body surface electrodes. Intended for use in hospitals or healthcare facilities by doctors and trained healthcare professionals. Contraindications: Not suitable for use in the presence of flammable anesthetic mixtures with air, oxygen, or nitrous oxide.

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., SE-1515 (K152427)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Public Health Service

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

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

Re: K161302

Trade/Device Name: PC ECG, model PADECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 28, 2016 Received: May 9, 2016

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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

Sincerely vours.

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) K161302

Device Name PC ECG, model PADECG

#### Indications for Use (Describe)

The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG 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. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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 Yang<br>June 29, 2016 |
| 2. Device name and<br>classification: | Device Name: PC ECG, model PADECG<br>Classification Name/ Product code:<br>870.2340 Electrocardiograph/DPS<br>Regulatory Class: Class II |
| 3.Premarket<br>Notification Class III<br>Certification and<br>Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Edan Instruments, Inc., SE-1515, K152427 |
| 5. Reason for<br>Submission | New Model. |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no Pre-Submission. |
| 7. Device Description: | PADECG is iPad-Based ECG work station. PADECG System<br>primarily composed of DX12(iOS) Transmitter and PADECG<br>Analysis Software, the product is designed to collect and<br>analyzes 12-Lead resting ECG. The DX12(iOS) Transmitter<br>contains lead wires and sends the ECG data to PADECG<br>Analysis Software through Bluetooth.<br>The PADECG Analysis Software will be uploaded to the App<br>Store, so that customers can download it to their own iPad and<br>install it. The PADECG Analysis Software which is installed in<br>the iPad can display the ECG data. The PADECG Analysis<br>Software can analysis the ECG data, and provide an advisory<br>diagnostic result. |

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8. Indications for Use: The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG 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. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.

## 9. 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 items, detailed comparison information can be found in the following tables.

| Item | PADECG | SE-1515 |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Edan Instruments, Inc) | (Edan Instruments, Inc) |
| 510(k)<br>Number | Current Submission | K152427 |
| Intended<br>Use | The intended use of PADECG is to<br>acquire resting ECG signals from adult<br>and pediatric patients through body<br>surface ECG electrodes. It is only<br>intended to be used in hospitals or<br>healthcare facilities by doctors and<br>trained healthcare professionals. The<br>cardiogram recorded by PADECG can<br>help users to analyze and diagnose heart<br>disease. However, the interpreted ECG<br>with measurements and interpretive<br>statements is offered to clinicians on an<br>advisory basis only. It is mainly used in<br>ECG inpatient department of hospitals<br>or healthcare facilities. | SE-1515 PC ECG is intended to acquire<br>process and store ECG signals from<br>adult and pediatric patients undergoing<br>stress exercise test or resting test. The<br>SE-1515 PC ECG is intended to be used<br>only in hospitals and healthcare<br>facilities by doctors and trained<br>healthcare professionals. The<br>cardiogram recorded by the SE-1515<br>PC ECG can help users to analyze and<br>diagnose heart diseases. However, the<br>ECG with measurements and<br>interpretive statements is offered to<br>clinicians on an advisory basis only. It<br>is mainly used in the ECG Outpatient<br>Department and Physical Examination<br>Department. |
| Lead<br>Number | 12 | 12/15/16/18 |
| Analysis<br>time | 10s | 10s |
| Measuring<br>the ECG | Amplitudes(mV),intervals(ms) and<br>slopes(mV/s) can be ensured on all | Amplitudes(mV),intervals(ms) and<br>slopes(mV/s) can be ensured on all |
| Item | PADECG | SE-1515 |
| | (Edan Instruments, Inc) | (Edan Instruments, Inc) |
| | ECG waveforms | ECG waveforms |
| Reanalysis | Manually change the measurement<br>marks of medians and the interpretation<br>result | Manually change the measurement<br>marks of medians and the interpretation<br>result |
| Vector loop | Do not support the Vector loop | Support the FRANK sampling and<br>Calculating VCG. Can show the<br>FRANK leads X,Y,Z wave and median<br>complexes of the orthogonal FRANK<br>leads X,Y,Z as well as the vector loops<br>in three plans |
| Interpretati<br>on library | Has Interpretation library and can edit | Has Interpretation library and can edit |
| Algorithm | Algorithm of the Smart ECG<br>Measurement and Interpretation<br>Programs(SEMIP), version 1.8 | Algorithm of the Smart ECG<br>Measurement and Interpretation<br>Programs(SEMIP), version 1.8 |
| CPU | Apple A5 or above | Pentium P4, Celeron D 310 or above |
| System<br>Memory<br>(RAM) | / | 1G or above |
| Capacity/H<br>ard Disk | 16GB or above | 128GB or above |
| Printer | / | ink jet printer of more than 300dpi or<br>laser printer<br>Recommend HP2035, HP2010,<br>CANON iP1980 |
| Display | iPad 4:9.7'1536×2048<br>iPad Air 1: 9.7'1536×2048<br>iPad Mini 2:7.9'1536×2048<br>iPad Mini 1:7.9'1024×768 | 17" TFT (Resolution: 1280*1024,<br>1366*768), 19" TFT (resolution:<br>1440×900), 21" TFT(1920*1080) |
| Operating<br>System | iOS 7,iOS 8, iOS 9 | Windows XP SP3 (32 bit), Windows 7<br>SP1 (32/64 bit) or Windows 8 (32/64<br>bit), Windows 8.1 (32/64 bit) |
| Operating | DX12 (iOS) Transmitter:<br>+5 ~+40 | DX12 Transmitter:<br>+5 ~+40 |
| Transport/S<br>torage | DX12 (iOS) Transmitter:<br>-20°C (-4°F)~+55°C | DX12 Transmitter:<br>-20°C (-4°F)~+55°C |
| Operating | DX12 (iOS) Transmitter:<br>15%~95%<br>Non-Condensing | DX12 Transmitter:<br>25% to 80% RH |
| Transport/S<br>torage | DX12 (iOS) Transmitter:<br>15%~95%<br>Non Condensing | DX12 Transmitter:<br>25% to 93% RH non-condensing |
| Item | PADECG<br>(Edan Instruments, Inc) | SE-1515<br>(Edan Instruments, Inc) |
| Safety<br>Standards | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-25<br>IEC60601-1-6<br>EN ISO14971 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-25<br>IEC60601-1-6<br>EN ISO14971 |
| Data<br>Transmission | Wireless Bluetooth<br>Technology(Version:2.0,Frequency:<br>2402-2480Hz) | USB interface and Wireless Bluetooth<br>Technology(Version:2.0,Frequency:<br>2402-2480Hz) |
| Anti-electric-shock<br>type | Class II | Class II |
| Anti-electric-shock<br>degree | Type CF with defibrillation-proof | Type CF with defibrillation-proof |
| Lead<br>number | 12-lead | 12-lead |
| Degree of<br>protection<br>against<br>harmful<br>ingress of<br>water | Enclosed equipment without protection<br>against ingress of water | Enclosed equipment without protection<br>against ingress of water |
| Degree of<br>safety of<br>application<br>in the<br>presence of<br>flammable<br>gas | Not suitable for use in the presence of a<br>flammable anesthetic mixture with air<br>or with oxygen or nitrous oxide | Not suitable for use in the presence of a<br>flammable anesthetic mixture with air<br>or with oxygen or nitrous oxide |
| Working<br>mode | Continuous operation | Continuous operation |
| Sampling<br>Rate | 10,000/sec/channel(sampling) | 10,000 /sec/channel (sampling) |
| Resolution | 2.52uV/LSB | 2.52uV/LSB |
| Time<br>Constant | ≥3.2 s | ≥3.2 s |
| Frequency<br>Response | 0.05 Hz ~ 150 Hz (-3 dB) | 0.05 Hz ~ 150 Hz (-3 dB) |
| Input<br>Impedance | ≥20MΩ (10Hz) | ≥20MΩ (10Hz) |
| System<br>Noise | <15µVp-p | <15µVp-p |
| Item | PADECG<br>(Edan Instruments, Inc) | SE-1515<br>(Edan Instruments, Inc) |
| Dynamic<br>Range | AC Differential ± 5mV, DC offset<br>±500mV | AC Differential ± 5mV, DC offset<br>±500mV |
| Common<br>Mode<br>Rejection | ≥100 dB | ≥100 dB |
| Pace Detect | ±2 to ±500 mV@0.1 to 2.0ms | ±2 to ±500 mV@0.1 to 2.0ms |
| ESD<br>Sensitivity | ±6 kV contact<br>±8 kV air | ±6 kV contact<br>±8 kV air |
| Heart Rate<br>Meter | 30 BPM ~300 BPM , ±1BPM | 30 BPM ~300 BPM , ±1BPM |
| High/Low<br>Pass Filters | AC Filter: 50 Hz/60 Hz/Off<br>DFT Filter: 0.32Hz/0.67Hz/0.05Hz<br>EMG Filter:<br>25Hz/35Hz/45Hz/Off<br>Lowpass Filter:<br>150Hz/100Hz/75Hz/Off | AC Filter: 50 Hz/60 Hz/Off<br>DFT Filter: 0.01 Hz/0.05 Hz/0.32 Hz/0.67 Hz<br>EMG Filter:<br>25 Hz/35 Hz/45 Hz/Off<br>Low Pass Filter:<br>300 Hz/270 Hz/150 Hz/100 Hz/75 Hz |

Comparison between PADECG and Predicate Device SE-1515

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All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.

## 10. Performance Data:

## Non-clinical data:

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for PADECG PC ECG device is conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. And the accessories of PADECG are all cleared.

## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the PADECG PC ECG device, consisting of all the accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 standards for safety and the IEC 60601-1-2: 2007 for EMC.

## Bench Testing

Bench testing was conducted on the PADECG PC ECG device, consisting of all the accessories in the system. The system complies with the IEC 60601-2-25: 2011 and IEC

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## 62366: 2007 standards.

ECG interpretation features were also validated by database testing.

## 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." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.

### Clinical data: Not applicable.

### Summary

Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.

## 11. Conclusion

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that PADECG PC ECG device should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject PADECG PC ECG device is substantially equivalent to the predicate devices.