Portable ECG Monitor

K170954 · Contec Medical Systems Co.,Ltd · DPS · May 30, 2017 · Cardiovascular

Device Facts

• Record ID: K170954
• Device Name: Portable ECG Monitor
• Applicant: Contec Medical Systems Co.,Ltd
• Product Code: DPS · Cardiovascular
• Decision Date: May 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition. It is suitable for the adult users, who suffers from cardiovascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references. The product is not a conventional diagnostic tool

Device Story

Handheld personal ECG monitor (PM10) records/stores Lead I ECG signals; displays heart rate. Operated by adult users in home setting. Device captures electrical heart activity via metal electrodes; transmits data to PC via USB or mobile phone via Bluetooth. Software on PC/mobile enables case upload, review, QRS interval/VEB measurement, and printing. Provides recorded data as reference for physicians; not a diagnostic tool. Benefits include convenient, on-demand cardiac monitoring for patients with cardiovascular disease or those tracking heart health.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified with IEC 60601-1, IEC 60601-1-2, and ISO 60601-2-47.

Technological Characteristics

Handheld ECG monitor; Lead I configuration; metal electrodes. Powered by rechargeable lithium battery. Connectivity: USB (PC), Bluetooth (mobile). Standards: IEC 60601-1, IEC 60601-1-2, ISO 60601-2-47. HR measurement range 30-300 bpm; accuracy ±1 bpm or 1%.

Indications for Use

Indicated for adult users with cardiovascular disease or those monitoring heart condition in daily life. For home health care use. Not for use as a conventional diagnostic tool.

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

• Handheld ECG Monitor (K093872)

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right.

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

June 5, 2017

Contec Medical Systems Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CN

Re: K170954

Trade/Device Name: Portable ECG Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 22, 2017 Received: March 31, 2017

Dear Ms. Diana Hong:

This letter corrects our substantially equivalent letter of May 30, 2017.

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 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.

M. G. Willemann

for
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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) K170954

Device Name Portable ECG Monitor

#### Indications for Use (Describe)

The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users, who suffers from cardiovascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.

The product is not a conventional diagnostic tool

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------|
| <div> <input checked="true" type="checkbox"/> Residential Use (Part 21 CFR 601 Subpart D) </div> |
| <div> <input type="checkbox"/> On-Site Septic System Use (State or Local Requirement) </div> |

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# K170954

# Page 1 of 4

# Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: ___________

1. Date of Preparation:03/24/2017

Sponsor Identification

### Contec Medical Systems Co., Ltd

No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China.

Establishment Registration Number: 3006979678

Contact Person: Xueyong Li Position: Quality Manager Tel: [phone] Fax: [phone] Email: [e-mail]

Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Mr. Cindy Wang (Alternative Contact Person)

## Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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K170954 Page 2 of 4

#### Identification of Proposed Device

Trade Name: Portable ECG Monitor Common Name: Electrocardiograph Model: PM10

Regulatory Information Classification Name: Electrocardiograph Classification: Class II Product Code: DPS Regulation Number: 21 CFR870.2340 Review Panel: Cardiovascular

Indication for use

The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.

The product is not a conventional diagnostic tool.

#### Device Description

The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.

The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, ORS interval and VEB measurement, print, etc.

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K170954 Page 3 of 4

510(k) Number: K093872 Product Name: Handheld ECG Monitor Model Name: MD100

Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2: 2014. Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

ISO 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.

Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison

| Item | Proposed Device(s) | Predicate Device(s) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | DPS | Same |
| Regulation Number | 870.2340 | Same |
| Indication for use | The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart | Similar |

Table 1 Comparison of Technology Characteristics

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| | rate message after ECG measurement. The<br>users can use it themselves to check their heart<br>condition.<br>It is suitable for the adult users, who suffers<br>from cardio-vascular diseases, or the adult<br>people who are caring about their heart<br>working conditions during their daily life.<br>This device is not intended for use as a<br>conventional diagnostic tool, but use as a<br>healthcare tool which can provide doctor the<br>recorded data as references.<br>The product is not a conventional diagnostic<br>tool. | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Lead | Lead I | Same |
| Recording mode | automatic | Same |
| Measurement<br>parameters | Heart rate, ECG waveform | Same |
| Display | LCD | Same |
| HR measurement<br>range | 30bpm~300bpm | Similar |
| HR measurement<br>accuracy | ±1bpm or 1% | Similar |
| Power supply | Battery | Same |
| Electrical safety | The proposed device was tested to<br>demonstrated to comply with IEC 60601-1 | Same |
| EMC | The proposed device was tested to<br>demonstrated to comply with IEC 60601-1-2 | Same |
| Patient Contact<br>Material | Metal electrode | Same |

Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.