PC ECG

K152427 · Edan Instruments, Inc. · DPS · Feb 5, 2016 · Cardiovascular

Device Facts

• Record ID: K152427
• Device Name: PC ECG
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Device Story

PC-based ECG system; acquires, processes, and stores ECG signals; supports 12, 16, and 18-lead configurations via wired (DE18, DE15, DP12) or wireless (DX12) sampling boxes. Wireless communication uses Bluetooth. For stress testing, integrates with external BP monitors and treadmills/ergometers. Used in hospitals/clinics by physicians and trained healthcare professionals. Software provides ECG measurements and interpretive statements on an advisory basis. Clinicians review output to assist in diagnosis and treatment decisions. Benefits include standardized ECG data acquisition and automated analysis to support clinical heart disease assessment.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), performance testing (IEC 60601-2-25), biocompatibility (ISO 10993-1), and software verification/validation.

Technological Characteristics

PC-based ECG system; wired/wireless sampling boxes; Bluetooth connectivity for wireless modules. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-25 (performance), ISO 10993-1 (biocompatibility). Features vector loop analysis (FRANK leads). Software: Moderate level of concern.

Indications for Use

Indicated for adult and pediatric patients undergoing stress exercise or resting ECG tests in hospitals and healthcare facilities.

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. SE-1010 (K131819)

Reference Devices

• Philips Medical Systems, Philips DXL 12/16-lead ECG Algorithm (K132068)
• Philips Medical Systems, Philips TC70 (K113144)

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 features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

February 5, 2016

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

Re: K152427

Trade/Device Name: PC ECG, model SE-1515 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 24, 2015 Received: December 28, 2015

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 yours.

Mitchell Stein

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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# Indications for Use

510(k) Number (if known) K152427

Device Name PC ECG, model SE-1515

#### Indications for Use (Describe)

SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements is offered to clinicians on an advisory basis only. It is mainly used in the ECG Outpatient Department and Physical Examination Department.

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

| 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: | Queena Chen<br>December 24, 2015 |
| 2. Device name and<br>classification: | Device Name: PC ECG<br>Model: SE-1515<br>Classification Name/ Product code:<br>870.2340 Electrocardiograph/DPS<br>Regulatory Class: Class II |
| 3. Predicate Device(s): | 1) EDAN Instrument, Inc. SE-1010, K131819 (Primary)<br>2) Philips Medical Systems, Philips DXL 12/16-lead ECG<br>Algorithm, K132068 (Reference)<br>3) Philips Medical Systems, Philips TC70, K113144(Reference) |
| 4. Reason for<br>Submission | New product. |
| 5. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. |
| 6. Device Description: | SE-1515 is a PC-based ECG designed to acquire, process and<br>store ECG signals and analyze and diagnose heart disease.<br>SE-1515 consists of analysis software and sampling boxes, and<br>has four configurations: Wired 18-lead ECG system, Wired<br>16-lead ECG system, Wired 12-lead ECG system and Wireless<br>12-lead ECG system.<br><br>Wired 18-lead ECG system consists of analysis software and<br>wired DE18 sampling box.<br><br>Wired 16-lead ECG system consists of analysis software and<br>wired DE15 sampling box. Wired 12-lead ECG system consists<br>of analysis software and wired DP12 sampling box. Wireless |
| | 12-lead ECG system contains analysis software, wireless DX12<br>sampling boxes (DX12 transmitter and DX12 receiver). The<br>communication between DX12 transmitter and DX12 receiver<br>is based on Bluetooth technology.<br>For stress exercise testing, the user should connect a BP<br>monitor and a treadmill or an ergo meter to the PC. |
| 7. Intended Use: | SE-1515 PC ECG is intended to acquire, process and store ECG<br>signals from adult and pediatric patients undergoing stress<br>exercise test or resting test. The SE-1515 PC ECG is intended<br>to be used only in hospitals and healthcare facilities by doctors<br>and trained healthcare professionals. The cardiogram recorded<br>by the SE-1515 PC ECG can help users to analyze and diagnose<br>heart diseases. However, the ECG with measurements and<br>interpretive statements is offered to clinicians on an advisory<br>basis only. |

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## 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 | SE-1515 | SE-1010 | Remark |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) Number | Current Submission | K131819 | ---- |
| Indications for Use | | | |
| Intended use | SE-1515 PC ECG is intended to acquire process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in the ECG | SE-1010 is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an | Different |
| | Outpatient Department and<br>Physical Examination<br>Department. | advisory basis only. | |
| High/Low Pass<br>Filters | DFT Filter:<br>0.01 Hz/0.05 Hz/0.32 Hz/0.67 Hz<br>AC Filter: 50 Hz/60 Hz/Off<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<br>Hz | DFT Filter: weak/strong<br>AC Filter: 50 Hz/60 Hz/Off<br>Low Pass/EMG Filter:<br>25 Hz/35 Hz/45 Hz/75 Hz/100<br>Hz/150 Hz | Different |
| Sampling Box | | | |
| ---- | DE15 | DP12 | ---- |
| Classification | | | |
| Anti-electric-sho<br>ck type | Class II | Class II | Same |
| Anti-electric-sho<br>ck degree | Type CF with defibrillation-proof | Type CF with<br>defibrillation-proof | Same |
| Lead number | 16-lead | 12-lead | Different |
| Degree of<br>protection<br>against harmful<br>ingress of water | Sealed equipment without<br>waterproof | Sealed equipment without<br>waterproof | Same |
| Degree of safety<br>of application in<br>the presence of<br>flammable gas | Equipment not suitable for use in<br>the presence of flammable gas | Equipment not suitable for use<br>in the presence of flammable<br>gas | Same |
| Working mode | Continuous operation | Continuous operation | Same |
| Processing | | | |
| Sampling Rate | 16 kHz /channel | 1 kHz /channel | Different |
| Resolution | 0.1575 µV/LSB @ 1 kHz | 2.52 µV/LSB @ 1 kHz | Different |
| Time Constant | >3.2 s | ≥3.2 s | Same |
| Frequency<br>Response | 0.01 Hz~300 Hz | 0.05 Hz ~ 150 Hz | Different |
| Input Impedance | ≥100 MΩ | >50 ΜΩ | Different |
| Dynamic Range | AC Differential ± 5 mV, DC<br>offset ±600 mV | AC Differential ± 5 mV, DC<br>offset ±600 mV | Same |
| System Noise | ≤12.5μ Vp-p | ≤12.5μ Vp-p | Same |
| Common Mode<br>Rejection | ≥140 dB(AC ON)<br>≥123 dB(AC OFF) | >110 dB | Different |
| Pace Detect | ±750 uV~±700 mV @ 50 us ~2.0<br>ms | ±2 to ±700 mV @ 0.1 ms to<br>2.0 ms | Different |
| ESD Sensitivity | +6 kV contact | +6 kV contact | Same |
| | ±8 kV air | ±8 kV air | |
| Heart Rate Meter | 30 BPM ~300 BPM, ±1 BPM<br>DE18 | 30 BPM ~300 BPM, ±1 BPM<br>DP12 | Same |
| Classification | | | |
| Anti-electric-sho<br>ck type | Class II | Class II | Same |
| Anti-electric-sho<br>ck degree | Type CF with defibrillation-proof | Type CF with<br>defibrillation-proof | Same |
| Lead number | 18-lead | 12-lead | Different |
| Degree of<br>protection<br>against harmful<br>ingress of water | Sealed equipment without<br>waterproof | Sealed equipment without<br>waterproof | Same |
| Degree of safety<br>of application in<br>the presence of<br>flammable gas | Equipment not suitable for use in<br>the presence of flammable gas | Equipment not suitable for use<br>in the presence of flammable<br>gas | Same |
| Working mode | Continuous operation | Continuous operation | Same |
| Processing | | | |
| Sampling Rate | 16 kHz /channel | 1 kHz /channel | Different |
| Resolution | 0.1575 µV/LSB @ 1 kHz | 2.52 µV/LSB @ 1 kHz | Different |
| Time Constant | ≥3.2 s | ≥3.2 s | Same |
| Frequency<br>Response | 0.01 Hz~300 Hz | 0.05 Hz ~ 150 Hz | Different |
| Input Impedance | ≥100 ΜΩ | >50 ΜΩ | Different |
| Dynamic Range | AC Differential ± 5 mV, DC<br>offset ±600 mV | AC Differential ± 5 mV, DC<br>offset ±600 mV | Same |
| System Noise | ≤12.5μ Vp-p | ≤12.5μ Vp-p | Same |
| Common Mode<br>Rejection | ≥140 dB (AC ON)<br>≥123 dB (AC OFF) | >110 dB | Different |
| Pace Detect | ±750 uV~±700 mV @ 50 us ~2.0<br>ms | ±2 to ±700 mV @ 0.1 ms to<br>2.0 ms | Different |
| ESD Sensitivity | ±6 kV contact<br>±8 kV air | ±6 kV contact<br>±8 kV air | Same |
| Heart Rate Meter | 30 BPM ~300 BPM, ±1 BPM | 30 BPM~300 BPM, ±1 BPM | Same |
| DP12 Sampling Box | | | |
| Classification | | | |
| Anti-electric-sho<br>ck type | Class II | Class II | Same |
| Anti-electric-sho<br>ck degree | Type CF with defibrillation-proof | Type CF with<br>defibrillation-proof | Same |
| Lead number | 12-lead | 12-lead | Same |
| | | | |
| protection<br>against harmful<br>ingress of water | protection against ingress of water | protection against ingress of water | |
| Degree of safety<br>of application in<br>the presence of<br>flammable gas | Not suitable for use in the<br>presence of a flammable<br>anesthetic mixture with air or with<br>oxygen or nitrous oxide | Not suitable for use in the<br>presence of a flammable<br>anesthetic mixture with air or<br>with oxygen or nitrous oxide | Same |
| Working mode | Continuous operation | Continuous operation | Same |
| <b>Processing</b> | | | |
| Sampling Rate | 1,000 /sec/channel | 1,000 /sec/channel | Same |
| Resolution | 2.52 $ μ $ V/LSB @ 1 kHz | 2.52 $ μ $ V/LSB @ 1 kHz | Same |
| Time Constant | $ ≥ $ 3.2 s…