Portable ECG Monitor

K152863 · Contec Medical Systems Co.,Ltd · DPS · Jun 22, 2016 · Cardiovascular

Device Facts

• Record ID: K152863
• Device Name: Portable ECG Monitor
• Applicant: Contec Medical Systems Co.,Ltd
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.

Device Story

Portable ECG Monitor PM10 records/stores Lead I ECG signals; displays heart rate. Intended for home health care use by adults >20 years old. Device consists of host unit and USB cable; powered by rechargeable lithium battery. Connectivity via USB to PC or Bluetooth to mobile phone. Software on PC/mobile enables sample mode, time setting, case upload, case review, and measurement. Simple user interface; no ECG trace viewing on device. Not a substitute for hospital diagnostic ECG. Benefits patient by providing accessible heart rate monitoring. Operated by patient.

Clinical Evidence

No clinical data. Bench testing only. Device verified against IEC 60601-1, IEC 60601-1-2, ISO 60601-2-47, IEC 60601-1-11, ISO 10993-5, and ISO 10993-10.

Technological Characteristics

Lead I ECG monitor; metal electrodes. Powered by rechargeable lithium battery. Connectivity: USB (PC), Bluetooth (mobile). Standards: IEC 60601-1, IEC 60601-1-2, ISO 60601-2-47, IEC 60601-1-11, ISO 10993-5, ISO 10993-10. Form factor: portable handheld device with LCD.

Indications for Use

Indicated for adults >20 years old for home health care use to record/store Lead I ECG signals and display heart rate. Contraindicated for users with implanted pacemakers.

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 (K112622)

Submission Summary (Full Text)

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Public Health Service

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

June 22, 2016

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

Re: K152863

Trade/Device Name: Portable ECG Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: May 20, 2016 Received: May 23, 2016

Dear Diana Hong:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K152863

Device Name Portable ECG Monitor

Indications for Use (Describe)

The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Tab #7 510(k) 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: 05/21/2016
- 2. 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]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (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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#### 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 CFR 870.2340 Review Panel: Cardiovascular

#### Intended Use Statement:

The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.

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, measurement etc.

- ર. Identification of Predicate Device
510(k) Number: K112622 Product Name: Handheld ECG Monitor Model Name: MD100A1-F

#### 6. 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:

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Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2: 2007, 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.

IEC 60601-1-11: 2010, MEDICAL ELECTRICAL EQUIPMENT – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

ISO 10993-5:2009(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

- 8. Substantially Equivalent (SE) Comparison

| Item | Proposed Device(s) | Predicate Device(s) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | DPS | Same |
| Regulation Number | 870.2340 | Same |
| Intended Use | The Portable ECG Monitor PM10 is intended<br>to record and store Lead I ECG signals, and<br>display heart rate for home health care use.<br>The intended users are adults above 20 years<br>old. This device is not intended to substitute<br>for a hospital diagnostic ECG device. Users<br>with implanted pacemaker are not<br>recommended to use this device. The Portable<br>ECG Monitor PM10 has simple user interface<br>without ECG trace viewing function. | Similar |
| Lead | Lead I | Same |
| Recording mode | automatic | Same |
| Measurement<br>parameters | Heart rate | Similar |
| Display | LCD | Same |
| HR measurement<br>range | 30bpm~300bpm | Similar |
| HR measurement<br>accuracy | ±1bpm or 1% | Similar |

Table 1 Comparison of Technology Characteristics

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| Power supply | Battery | Same |
|--------------------------|-----------------------------------------------------------------------------|------|
| Electrical safety | The proposed device was tested to demonstrated to comply with IEC 60601-1 | Same |
| EMC | The proposed device was tested to demonstrated to comply with IEC 60601-1-2 | Same |
| Patient Contact Material | Metal electrode | Same |

#### 9. 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.