DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 by SHENZHEN BIOCARE ELECTRONICS CO., LTD

Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire ECG signals from adult and pediatric 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

Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data and patient information could be stored in the memory of the device. All the models, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, of the proposed device, Digital Electrocardiographs, follow the same design principle and same technical specifications: They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Digital Electrocardiographs (ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010). However, the document does NOT contain the detailed information required to answer all the questions about acceptance criteria and the specific study proving the device meets them. The text primarily focuses on the regulatory submission, intended use, device description, and the determination of substantial equivalence to a predicate device.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "Performance testing was conducted to validate and verify that the proposed devices met all design specifications and was substantially equivalent to the predicate device." However, it does not provide the specific acceptance criteria (e.g., accuracy, sensitivity, specificity for specific ECG features) or the reported performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

There is no indication that an MRMC comparative effectiveness study involving AI or human reader improvement was conducted. The device is a Digital Electrocardiograph, which is a signal acquisition and display device, not an AI-powered diagnostic tool. The document focuses on hardware performance and substantial equivalence to a predicate ECG device.

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

The device itself is a standalone electrocardiograph. The "algorithm" in this context refers to the device's ability to acquire, amplify, filter, display, and record ECG signals. The performance testing would inherently be assessing the device's standalone functionality. However, specific performance metrics for this standalone functionality are not detailed. It's not an AI algorithm in the common sense of the term for this type of device.

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

This information is not provided in the document. For an ECG device, ground truth for performance testing would typically involve a reference standard for signal accuracy, frequency response, common mode rejection, etc., which might be established by calibrated equipment or known physiological signals.

8. The sample size for the training set

This is not applicable as the device is not described as using a machine learning model that requires a training set. It's a standard medical device for signal acquisition.

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

This is not applicable for the same reason as point 8.

Summary of available information:

The document confirms that performance testing was conducted to ensure the device met design specifications and was substantially equivalent to the predicate device (Smart ECG (SE) Series Electrocardiograph, SE-12, K091513). However, it lacks the specific details of these tests, including acceptance criteria, performance results, sample sizes, and how ground truth was established, which would typically be found in a more detailed study report, not a 510(k) summary.

Summary

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Exhibit #1 510(k) Summary - K101876 Digital Electrocardiographs

Exhibit #1 510(k) Summary

MAR - 1 2010

This 510(k) Summary is prepared per the request of 21 CFR 807.92.
Date	19 JAN 2011
Sponsor	Shenzhen Biocare Electronics Co., Ltd
	5/F, Taohuayuan High-Tech Innovation Park, Baoan
	Shenzhen, Guangdong, 518102, China
Correspondent	Ms. Diana Hong / Mr. Lee Fu
	Shanghai Mid-Link Business Consulting Co., Ltd
	Suite 5D, No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China
Proposed Device	Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010
Classification	Electrocardiograph; DPS; 21CFR870.2340; Class II
Intended Use	Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire
	ECG signals from adult and pediatric 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	Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are designed to acquire,
Description	display and record ECG signals from patient body surface by ECG electrodes. After been amplified,
	filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal
	printer. ECG data and patient information could be stored in the memory of the device.
	All the models, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, of the proposed device, Digital
	Electrocardiographs, follow the same design principle and same technical specifications: They consist of
	four modules, which are power supply module, signal collection module, amplification module, and
	control module.
Testing	Performance testing was conducted to validate and verify that the proposed devices met all design
	specifications and was substantially equivalent to the predicate device.
Predicate Device	Smart ECG (SE) Series Electrocardiograph, SE-12, K091513
SE Conclusion	The proposed devices, Digital Electrocardiograph ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are
	claimed to be Substantially Equivalent (SE) to the predicate device, Smart ECG (SE) Series
	Electrocardiograph, SE-12, in safety and effectiveness concerns.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human services.

Public Health Service

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

Shenzhen Biocare Electronics Co., Ltd c/o Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No. 19, Lane 999, Zhongshan Road (S-2) Shanghai, 200030 CHINA

MAR - 1 2011

Re: K101876

Trade Name: Digital Electrocardiograph, Models ECG-1210, ECG-1230, ECG-3010, ECG-6010 Regulation Number: 21 CFR 870.2340

Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: February 20, 2011 Received: February 23, 2011

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.

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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/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,

W.M.S.

Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit #2 Indications for Use Statement

510(k) Number: K101876 Device Name: Digital Electrocardiographs Models: ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010

Indications for Use:

ZPRESCRIPTION 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)

W.M.P

n of Cardiovascular Devices

510(k) Number K101876

Page 1 of 1

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).