CONTECTM Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Device Description

The proposed device, CONTECTM Electrocardiograph, has three models: ECG100G, ECG300G and ECG1200G. The three models all have three design modules, which are power module, signal acquisition and processing module and control module. The proposed devices acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via single channel/ three channel/ twelve channel. The proposed device, model ECG100G, has two recording modes, including automatic mode and manual mode; the other two models, ECG300G and ECG1200G have three recording modes, including automatic mode, manual mode and rhythm mode. The proposed devices are designed to acquire, process, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed on the LCD screen and recorded on the paper through thermal printer. ECG data, waveform and patient information could be stored in the memory of the device;

AI/ML Overview

The provided document K131900 is a 510(k) summary for the CONTECTM Electrocardiograph. It outlines the device's technical specifications and compares it to predicate devices to establish substantial equivalence. However, it does not describe a clinical study with acceptance criteria and reported device performance in the way a traditional clinical efficacy study would.

Instead, this document focuses on non-clinical tests to verify that the proposed device meets design specifications and complies with relevant international and national standards. The acceptance criteria are implicit in these standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with corresponding "reported device performance" in terms of clinical outcomes or diagnostic accuracy. Instead, the document states that "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 "reported device performance" is the statement that it complies with the listed standards and its technical specifications match or are similar to the predicate devices.

Feature/Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Safety	Compliance with IEC 60601-1:1988+A1:1991+A2:1995	Complies with IEC 60601-1:1988+A1:1991+A2:1995
EMC	Compliance with IEC 60601-1-2: 2007	Complies with IEC 60601-1-2: 2007
ECG Safety	Compliance with IEC 60601-2-25:1993+A1:1999	Complies with IEC 60601-2-25:1993+A1:1999
Diagnostic ECG	Compliance with ANSI/AAMI EC11:1991/(R) 2007	Complies with ANSI/AAMI EC11:1991/(R) 2007
Patient Leak Current	<10μA	<10μA (Same as predicate)
Frequency Response	0.05~150Hz	0.05~150Hz (Same as predicate)
Noise Level	<15μVp-p	<15μVp-p (Same as predicate)
CMRR	>60 dB (general), >100 dB (with AC filter)	>60 dB, >100 dB (with AC filter) (Similar to predicate)
Input CIR current	<50nA	<50nA (Same as predicate)
Input Impedance	>50M Ω	>50M Ω (Same as predicate)
Intended Use	Acquire ECG signals from adult patients, help users analyze and diagnose heart disease in healthcare facilities by doctors/professionals.	(Stated as intended use, presumed to be met by device function)
Technical Features	1/3/12 channel, Simultaneous 12-lead acquisition, specific recording modes (auto/manual/rhythm for ECG300G/ECG1200G, auto/manual for ECG100G)	Matches predicate devices or is clearly described.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the context of diagnostic accuracy. The tests performed are non-clinical, related to electrical safety, electromagnetic compatibility, and performance according to engineering standards. There is no mention of patient data or its provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrocardiograph, which acquires and displays ECG signals. It does not appear to incorporate AI for interpretation or assistance with human readers. The document does not mention any "Measurement/Analysis Function" for the proposed device, as shown in the comparison table where it explicitly states "No" for this function, contrasting with one of the predicate devices that has "Yes".

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device itself is an acquisition device, not an algorithm for interpretation. It explicitly states "No" for "Measurement/Analysis Function."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. As described, the "ground truth" for this submission are the engineering and medical device standards (e.g., IEC 60601 series, ANSI/AAMI EC11) which define acceptable electrical and physical performance, rather than diagnostic accuracy against a clinical gold standard.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device with an interpretation algorithm.

9. How the ground truth for the training set was established

Not applicable. As above, no training set or its ground truth establishment is mentioned.

Summary of the Study:

The "study" described in K131900 is a series of non-clinical bench tests designed to demonstrate that the CONTECTM Electrocardiograph adheres to established electrical safety, electromagnetic compatibility (EMC), and specific performance standards for electrocardiographs. The "acceptance criteria" are the requirements set forth in these international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ANSI/AAMI EC11) and the technical specifications listed in the comparison table, which are either identical or similar to legally marketed predicate devices. The "proof" is the statement that "The test results demonstrated that the proposed device complies with the following standards" and the detailed comparison table that shows its technical specifications meet or are equivalent to the predicate devices. This type of submission is common for medical devices that aim to show substantial equivalence based on technical and performance characteristics, without requiring new clinical efficacy data if the intended use and technology are sufficiently similar to approved predicate devices.

Summary

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K131900 Page 1 of 4

510(k) Summary

ﺮ

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

The assigned 510(k) Number: _ K131900

Date of Submission: Jun 21, 2013

Sponsor Identification 2.

Contec Medical System Co., Ltd No. 24, Huanghe West Road, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China

Establishment Registration Number: 3006979678

Contact Person: Mr. Xueyong Li Position: Quality Manager Tel: +86-335-8015490 Fax: +86-335-8015489 Email: lxy1011@163.com

Submission Correspondent 3.

Ms. Diana Hong& Mr. Tarzan Wang 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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4. Proposed Device Identification

Proposed Device Name: CONTECTM Electrocardiograph Proposed Device Common Name: Digital Electrocardiograph

Regulatory Information: Classification Name: Electrocardiograph Classification: II; Product Code: DPS Regulation Number: CFR 870.2340 Review Panel: Cardiovascular

Intended Use Statement:

న్నా Predicate Device Identification

510(k) Number: K113485 Predicate Device: Electrocardiographs Product Model: ECG-1101G(1), ECG-1103G(1) and ECG-1112 Manufacturer: Shenzhen Carewell Electronics Co., Ltd

510(k) Number: K122712 Predicate Device: Digital Electrocardiographs Product Model: iE 3S and iE 12 Manufacturer: Shenzhen Biocare Electronics Co., Ltd

6. Device Description

The proposed device, CONTECTM Electrocardiograph, has three models: ECG100G, ECG300G and ECG1200G.

The three models all have three design modules, which are power module, signal acquisition and processing module and control module.

The proposed devices acquire ECG signal via twelve leads simultaneously, display or print waveform of E3-2

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ECG signal via single channel/ three channel/ twelve channel.

The proposed device, model ECG100G, has two recording modes, including automatic mode and manual mode; the other two models, ECG300G and ECG1200G have three recording modes, including automatic mode, manual mode and rhythm mode.

The proposed devices are designed to acquire, process, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed on the LCD screen and recorded on the paper through thermal printer. ECG data, waveform and patient information could be stored in the memory of the device;

7. 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 60601-1:1988+ A1:1991+ A2:1995, Medical electrical equipment, Part 1: General requirements for safety.

IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests

IEC 60601-2-25:1993+A1:1999, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.

ANSI/AAMI EC11:1991/(R) 2007, Diagnostic electrocardiographic devices

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8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate devices with respect to intended use, technological characteristics and product function, etc.

ITEM	Proposed Device	Predicate Device	Predicate Device
	CONTECTM Electrocardiograph	K113485	K122712
Model	ECG100G/ECG300G/ECG1200G	ECG-1101G(I)/ECG-1103G(I)/ECG-1112	iE 3S/ iE 12
Code	DPS	SAME	SAME
Regulation No.	CFR 870.2340	SAME	SAME
Channel	1/3/12 channel	SAME	SAME
Acquisition mode	Simultaneous 12-lead acquisition	SAME	SAME
Recording mode	ECG100G: Automatic / ManualECG300G/ECG1200G: Automatic /Manual/rhythm	Automatic / Manual/rhythm	Automatic / Manual/rhythm
Patient leakcurrent	<10μA	SAME	SAME
Frequencyresponse	0.05~150Hz	SAME	SAME
Noise level	<15μVp-p	SAME	SAME
CMRR	>60 dB>100 dB (with AC filter)	SIMILAR	SIMILAR
Measurement/AnalysisFunction	No	Yes	No
Input CIR current	<50nA	SAME	SAME
Input impedance	>50M Ω	SAME	SAME

Table 3-1 Comparison of Technology Characteristics
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The proposed device, CONTECTM Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate devices, Electrocardiographs (K113485) and Digital Electrocardiographs (K122712), in respect of safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body. 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 20993-002

March 5. 2014

Contec Medical System Co., Ltd. c/o Ms. Diana Hong Regulatory Consultant P.o. Box 120-119 Shanghai, 200120 CHINA

Re: K131900

Trade/Device Name: Contec electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: January 16, 2014 Received: January 24, 2014

Dear Ms. 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 (reporting of medical

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Page 2 - Ms. Diana Hong

device-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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 vours

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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K131900

Page l of

510(k) Number (if known):

Device Name: CONTEC Electrocardiograph

Indications For Use: CONTEC Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

(19) FASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) for Bram Zuckerman

Prescription Use_ X (Per 21 CFR 801.109)

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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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).