Digital Electrocardiograph is 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 Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Device Description

Digital Electrocardiograph, ECG-2000, is 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.

It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.

AI/ML Overview

The provided text is a 510(k) summary for a Digital Electrocardiograph (ECG-2000) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical specifications. It does not contain information about acceptance criteria for device performance based on clinical studies, nor does it describe such a study.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.

The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and complied with relevant IEC and EN standards for electrical safety, EMC, and particular requirements for electrocardiographs. It also mentions "Software Verification Test was performed to verify the software functions against its intended use." However, these are engineering verification tests, not clinical performance studies for diagnostic accuracy.

The closest to "acceptance criteria" presented in the document are the technical specifications compared with predicate devices, such as:

Item	Acceptance Criteria (from predicate device comparison)	Reported Device Performance (Proposed Device)
Product Code	DPS	DPS
Regulation Number	21 CFR 870.2340	21 CFR 870.2340
Class	Class II	Class II
ECG Lead	Standard 12-lead	Standard 12-lead
Sampling rate	1000Hz (at least for one predicate)	1000Hz
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Input circuit current	≤0.1 μA (for one predicate)	≤0.1 μA
Noise level	<15μ Vp-p (for one predicate)	<15μ Vp-p

Summary of missing information:

A table of acceptance criteria and the reported device performance from a clinical study: Not available. The document refers to engineering specifications and compliance with standards, not diagnostic performance metrics from clinical data.
Sample sized used for the test set and the data provenance: Not available. No clinical test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No clinical ground truth establishment is described.
Adjudication method for the test set: Not available.
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 available. This device is a Digital Electrocardiograph, not an AI-assisted diagnostic tool as described by the question.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. The device acquires ECG signals; it's not an algorithm that performs diagnosis independently for performance evaluation in this context.
The type of ground truth used: Not available.
The sample size for the training set: Not available.
How the ground truth for the training set was established: Not available.

Summary

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

January 22, 2015

Shenzhen Biocare Bio-Medical Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CH

Re: K133985

Trade/Device Name: Digital Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 3. 2014 Received: December 5, 2014

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 (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 (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,

Melissa A. Torres -S

For

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

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Indications for Use

510(k) Number (if known) K133985

Device Name

Digital Electrocardiograph ECG-2000

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiograph 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)
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Tab #3 510(k) Summary

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: K133985

1. Date of Submission: 01/07/2015
1. Sponsor Identification

Shenzhen Biocare Bio-Medical Equipment Co., Ltd Room A735, Floor 7, Tower A, Shenzhen Famous Industrial Procurement & Exhibition Center, No. 168 Baoyuan Road, Baoan, Shenzhen, 518102, P.R. China

Establishment Registration Number: 3008457078

Contact Person: Mr. Hongbo Zhong Position: Director Tel: +86-755-36615333-8856 Fax: +86-755-27960643 Email: hb-zhong@tom.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Lee Fu 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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Proposed Device Identification 4.
Proposed Device Name: Digital Electrocardiograph Model: ECG-2000 Proposed Device Common Name: Electrocardiograph

Regulatory Information: Classification Name: Electrocardiograph Classification: II; Product Code: DPS; Regulation Number: 21 CFR part 870.2340; Review Panel: Cardiovascular;

Intended Use Statement:

న్. Predicate Device Identification
Predicate Device 1 510(k) Number:K092010 Product Name: PC ECG Manufacturer: Edan Instruments, Inc.

Predicate device 2 510(k) Number: K123816 Product Name: Digital Electrocardiographs iE 12A Manufacturer: Shenzhen Biocare Electronics Co., Ltd

Device Description 6.
Digital Electrocardiograph, ECG-2000, is 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.

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powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.

1. 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.

EN 60601-1-2:2007+AC:2010, 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: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

Software Verification Test was performed to verify the software functions against its intended use.

Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device	Predicate Device 1	Predicate Device 2
Product Code	DPS	Same	Same
Regulation Number	21 CFR 870. 2340	Same	Same
Class	Class II	Same	Same
Intended Use	Digital Electrocardiograph isintended to acquire ECG signalsfrom adult patients through bodysurface ECG electrodes. Theobtained ECG records can helpusers to analyze and diagnose heart	Similar	Similar
	disease. Digital Electrocardiograph

Table 3-1 Comparison of Technology Characteristics

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	shall be used in healthcare facilitiesby doctors and/or trained healthcareprofessionals.
Configuration	Chest Electrode and Limb Electrode	Same	Same
ECG Lead	Standard 12-lead	Same	Same
ECG Gain	1.25, 2.5, 5, 10, 20, 10-5, 20-10(mm/mV)	Similar	Same
Sampling rate	1000Hz	Same	Same
Input circuit current	≤0.1 μΑ	Similar	Same
Noise level	<15μ Vp-p	Similar	Same
Electrical Safety	Comply with IEC 60601-1	Same	Same
EMC	Comply with IEC 60601-1-2	Same	Same
Patient-contactMaterial	Chest Electrode: MetalLimb Electrode: ABS	Same	Same

SE Discussion

The proposed device provides more options for gains than those of the predicate device 1, therefore, this difference will not affect the safety and effectiveness;

The proposed device provides a wider range of bandwidth than that of the predicate device 1. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

The noise level and input circuit current of the proposed and predicate device 1 are different, however both the specifications comply with IEC 60601-1.

SE Conclusion

The proposed device, Digital Electrocardiograph EG-2000, is determined to be Substantially Equivalent (SE) to the predicate devices, PC ECG (K092010) and Digital Electrocardiographs iE 12A (K123816), in respect of safety and effectiveness.

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).