ELECTROCARDIOGRAPH by SHENZHEN CAREWELL ELECTRONICS CO., LTD

Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection. Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Device Description

Carewell Digital Electrocardiographs, ECG-1101G(I) / ECG-1103G(I)/ ECG-1103LW(I) / ECG-1106L /ECG-1112 / ECG-1112D, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, fittered and analyzed, the ECG signal waveforms and analysis results are displayed on the LCD and recorded on the paper through thermal printer. ECG data, result and patient information could be stored in the memory of the device.

All the models, ECG-1101G(1) / ECG-1103G(1) ECG-1103LW(1) / ECG-1106L /ECG-1112 / ECG-1112D of the proposed device, Carewell Digital Electrocardiographs, have difference in appearance. but follow the same design principle and similar technical specifications:

They consist of three modules, which are power module and control module, and they have three operation modes, including AUTO Mode (automatic mode), MAN Mode (manual mode) and ANA Mode (analysis mode).

They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads. And they are using the same accessories.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document references adherence to several standards but does not explicitly state quantitative acceptance criteria or detailed performance results in terms of accuracy or specific metrics for QRS detection, Heart Rate, VEB, SVEB, or ST Segment Deviation. The statement "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device" is a general claim rather than a detailed performance report.

However, the "Intended Use Statement" lists the capabilities that the device is designed to perform, which implies expected performance for these metrics. Based on the mention of ANSI/AAMI EC57:2003, Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms, it can be inferred that the device was tested against the performance requirements outlined in this standard. Without direct access to the full test report or the specific criteria within EC57 for this submission, we can only list the intended functionalities as the implied performance areas.

Metric/Functionality	Acceptance Criteria (Implied by Standards/Intended Use)	Reported Device Performance
QRS Detection	Meets requirements of ANSI/AAMI EC57:2003	Assumed to meet; deemed SE to predicate
Heart Rate	Meets requirements of ANSI/AAMI EC57:2003	Assumed to meet; deemed SE to predicate
Ventricular Ectopic Beat (VEB)	Meets requirements of ANSI/AAMI EC57:2003	Assumed to meet; deemed SE to predicate
Supraventricular Ectopic Beat (SVEB)	Meets requirements of ANSI/AAMI EC57:2003	Assumed to meet; deemed SE to predicate
ST Segment Deviation	Meets requirements of ANSI/AAMI EC57:2003	Assumed to meet; deemed SE to predicate

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

The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation of the ECG measurement algorithms (QRS, HR, VEB, SVEB, ST Segment). It only mentions "Bench tests were conducted to verify that the proposed device met all design specifications."

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

The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for the test set.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed according to the provided text. The submission focuses on device equivalence and performance against standards, not on human reader improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone study was indicated. The document states, "Bench tests were conducted to verify that the proposed device met all design specifications." The purpose of these tests was to demonstrate that the device's algorithms (for QRS detection, Heart Rate, VEB, SVEB, and ST Segment Deviation) performed according to established standards (specifically referencing ANSI/AAMI EC57:2003), enabling the device to be considered "Substantially Equivalent" to a predicate device. This implies testing of the algorithm's performance independent of human-in-the-loop interaction.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the performance evaluation of the algorithms. However, given the reference to ANSI/AAMI EC57:2003, Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms, it is highly probable that a standard, meticulously annotated ECG database (potentially with expert consensus annotations or derived from clinical events) would have been used to establish the ground truth for evaluating the algorithm's performance against the specified metrics.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set.

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

The document does not provide any information on how the ground truth for the training set was established, as no details about a training set are mentioned.

Summary

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Exhibit #1510(k) Summary

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

The assigned 510(k) Number: K113485

1. Date of Submission:April 5, 2012
1. Sponsor

Shenzhen Carewell Electronics Co., Ltd 5A, Huating 3, TimeCity, Chuangye Road, Nanshan, Shenzhen 518054, P.R. China Contact Person: Jason Kang Position: General Manager Tel: +86-755-86170389 Email: standard@carewell.com.cn

1. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023 Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1. Proposed Device Identification

Proposed Device Name:Electrocardiograph Proposed Device Model:ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1112 and

ECG-1112D

Classification: II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular

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Premarket Notification 510(k) Submission Exhibit #1 510(k) Summary Project #:M0142011 Ac

Intended Use Statement:

1. Predicate Device Identification
510(k) Number:K101876 . Product Name:Digital Electrocardiograph Manufacturer:Digital Electrocardiograph
1. Device Description

They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads. And they are using the same accessories.

Non-Clinical Test Conclusion 7.
Bench 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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Premarket Notification 510(k) Submission Exhibit #1 510(k) Summary Project #:M0142011Ac

IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment Part 1: General A requirements for safety;
IEC 60601-1-2:2001 +A1: 2007, Medical Electrical Equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests;
A IEC 60601-2-25: 1993+ A1:1999, Medical Electrical Equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers;
ANSI/AAMI EC11:1991/(R)2007, Diagnosis electrocardiographic devices;
ANSI/AAMI EC38:1998, Ambulatory electrocardiographs;
ANSI/AAMI EC57:2003,Testing and Reporting performance results of cardiac rhythm and ST-segment measurement algorithms;
V AAMI EC53:1998, ECG cables and leadwieres;
A ISO 10993-5:2009 Standard, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity";
A ISO 10993-10:2002 Standard and Amendment 1:2006. "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1";
1. Substantially Equivalent Conclusion

The proposed device, Electrocardiographs, is determined to be Substantially Equivalent (SE) to the predicate device, Digital Electrocardiograph, K101876, in respect of safety and effectiveness.

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Image /page/3/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 stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

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

APR 2 5 2012

Shenzhen Carewell Electronics Co., Ltd c/o Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd PO Box 237-023 Shanghai, 200030, China

Re: K113485

Trade/Device Name: Electrocardiograph ECG-1101G(I), ECG-1103G(I), ECG-1103LW(I), ECG-1106L, ECG-1112 and ECG-1112D Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: April 5, 2012 Received: April 9, 2012

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.

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.

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Page 2 – Ms. Diana Hong

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Premarket Notification 510(k) Submission

Exhibit #2 Indication for Use Project #:M0142011Ac

Exhibit #2Indications for Use

510(k) Number: Ki13485 Device Name: Electrocardiographs

Indications for Use:

Electrocardiographs, ECG-1101G(1), ECG-1103G(1), ECG-1103LW(1), ECG-1106L, ECG-1122 and ECG-1112D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection, Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

&PRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

of Cardiovascular Devices

510(k) Number K113485

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).