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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Portable ECG Monitor (Model PM10) by Contec Medical Systems Co., Ltd. It declares substantial equivalence to a predicate device (Handheld ECG Monitor Model MD100, K093872).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically used in clinical studies for diagnostic accuracy. Instead, it relies on demonstrating compliance with non-clinical performance and safety standards, and technological characteristics similar to a predicate device.

However, we can extract the reported performance for specific parameters:

Acceptance Criteria (Implied)	Reported Device Performance (Proposed Device)
Non-Clinical Performance
Electrical Safety	Complies with IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2: 2014
Ambulatory Electrocardiographic Systems	Complies with ISO 60601-2-47:2012
Measurement Parameters
Lead	Lead I
Recording mode	Automatic
Measurement parameters	Heart rate, ECG waveform
Display	LCD
HR measurement range	30bpm~300bpm
HR measurement accuracy	±1bpm or 1%
Power supply	Battery
Patient Contact Material	Metal electrode

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no information regarding sample size for a test set, nor data provenance (country of origin, retrospective/prospective). The assessment of the device's performance for regulatory purposes is primarily based on non-clinical testing and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical study was conducted, there is no information on the number of experts or their qualifications for establishing ground truth from a test set.

4. Adjudication Method for the Test Set

As there was no clinical study, there is no adjudication method described for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader, multi-case comparative effectiveness study was not done. The document states "No clinical study is included in this submission." Consequently, there is no information on the effect size of human readers improving with AI vs. without AI assistance, as the device is an ECG monitor and not an AI-assisted diagnostic tool described in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study of an algorithm's performance without human-in-the-loop was not done, as no clinical study was conducted. The device (Portable ECG Monitor) is described as recording and displaying ECG signals and heart rate, not as employing a complex algorithm that would typically undergo such standalone performance evaluation in a regulatory submission of this nature.

7. Type of Ground Truth Used

As there was no clinical study, no ground truth from expert consensus, pathology, or outcomes data was established or used for the purpose of demonstrating clinical performance. The "ground truth" implicitly referred to here is the accurate measurement of electrical signals and heart rate as per the device's physical and technical specifications, validated through engineering bench testing and compliance with relevant IEC and ISO standards.

8. Sample Size for the Training Set

Since no clinical study was performed and no AI/machine learning algorithm requiring a training set is explicitly described or implied beyond standard signal processing for ECG and heart rate, there is no information regarding a training set sample size.

9. How the Ground Truth for the Training Set Was Established

Given that no training set is mentioned or implied for an AI/ML algorithm within the provided document, there is no information on how ground truth for a training set was established.

Summary

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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 (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.

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)
Residential Use (Part 21 CFR 601 Subpart D)
On-Site Septic System Use (State or Local Requirement)

|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: ___________

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

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

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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 product is not a conventional diagnostic tool.

Device Description

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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. Theusers can use it themselves to check their heartcondition.It is suitable for the adult users, who suffersfrom cardio-vascular diseases, or the adultpeople who are caring about their heartworking conditions during their daily life.This device is not intended for use as aconventional diagnostic tool, but use as ahealthcare tool which can provide doctor therecorded data as references.The product is not a conventional diagnostictool.
Lead	Lead I	Same
Recording mode	automatic	Same
Measurementparameters	Heart rate, ECG waveform	Same
Display	LCD	Same
HR measurementrange	30bpm~300bpm	Similar
HR measurementaccuracy	±1bpm or 1%	Similar
Power supply	Battery	Same
Electrical safety	The proposed device was tested todemonstrated to comply with IEC 60601-1	Same
EMC	The proposed device was tested todemonstrated to comply with IEC 60601-1-2	Same
Patient ContactMaterial	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.

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).