K Number

Device Name

Portable ECG Monitor

Manufacturer

CONTEC MEDICAL SYSTEMS CO., LTD

Date Cleared

2016-06-22

(266 days)

Product Code

DPS

Regulation Number

870.2340

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K112622

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a basic ECG monitor that records and displays heart rate. There is no mention of AI, ML, or any advanced analytical capabilities beyond simple signal processing for heart rate calculation. The performance studies focus on electrical safety and equivalence to a predicate device, not on algorithmic performance.

Therapeutic

No
The device is intended to monitor and store ECG signals and display heart rate for informational purposes in a home setting, not to directly treat or alleviate a medical condition. It explicitly states it is "not intended to substitute for a hospital diagnostic ECG device."

Diagnostic

The "Intended Use / Indications for Use" section explicitly states, "This device is not intended to substitute for a hospital diagnostic ECG device." While it records ECG signals, it's positioned for home health care and not for clinical diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is "composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The Portable ECG Monitor PM10 records and stores Lead I ECG signals and displays heart rate. This is a measurement of electrical activity within the body, not an analysis of a sample taken from the body.
Intended Use: The intended use is for "home health care use" to "record and store Lead I ECG signals, and display heart rate." This aligns with monitoring physiological signals, not performing in vitro tests.

Therefore, the device falls under the category of a physiological monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DPS

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults above 20 years old

Intended User / Care Setting

home health care use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 60601-1-2: 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.
No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

HR measurement accuracy: ±1bpm or 1%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112622

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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 often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is 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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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)

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
1. 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: 86 355 8015489 Fax: 86 355 8015490 Email: lxy1011@163.com

1. 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: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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:

Device Description

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

6. Non-Clinical Test Conclusion

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.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. 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
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.	Similar
Lead	Lead I	Same
Recording mode	automatic	Same
Measurement
parameters	Heart rate	Similar
Display	LCD	Same
HR measurement
range	30bpm~300bpm	Similar
HR measurement
accuracy	±1bpm or 1%	Similar

Table 1 Comparison of Technology Characteristics

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.