The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Device Description

Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.

They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.

The CardioPro analysis program is the analysis program used in this proposed device.

AI/ML Overview

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity regarding the analysis and diagnosis of heart disease. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and compliance with international safety and performance standards.

The table below summarizes the technical specifications and standards compliance, which implicitly serve as performance requirements for the device's functionality.

Feature / Standard	Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance
Product Code	DPS	DPS
Regulation Number	21 CFR 870.2340	21 CFR 870.2340
Lead Acquisition	Standard 12-lead (or 15-lead for proposed device)	Standard 12-lead or 15 lead
Acquisition mode	Simultaneous 12-lead acquisition	Simultaneous 12-lead or 15 lead acquisition
Recording format	Automatic / Manual / Rhythm	Automatic / Manual / Rhythm
Analysis mode	Yes (presence of analysis program)	Yes (CardioPro analysis program)
CMRR	>60dB	>60dB, >100 with AC filter
Paper Speed	Multiple levels (e.g., 6.25, 12.5, 25, 50mm/s)	4-6 levels (e.g., 6.25, 12.5, 25, 50mm/s)
Input CIR current	≤0.1μA	≤0.1μA
Input impedance	>50MΩ	>50MΩ
Patient leak current	<10μA	<10μA
Frequency response	0.05~150Hz	0.05~150Hz
Noise level	<15μVp-p	<15μVp-p
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
Particular requirements	Comply with IEC 60601-2-25	Comply with IEC 60601-2-25
Biocompatibility	Comply with ISO 10993	Comply with ISO 10993

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

The document does not mention a specific "test set" in the context of clinical performance for the interpretation of ECGs or diagnosis of heart disease. The provided information is focused on non-clinical testing to demonstrate compliance with general safety and performance standards (IEC standards) and an assessment of technical characteristics against predicate devices. Therefore, details like data provenance (country of origin, retrospective/prospective) are not applicable or provided for a clinical test set.

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

As there is no mention of a clinical test set with ground truth related to ECG interpretation or diagnosis in this document, there is no information about the number or qualifications of experts used for establishing ground truth. The device's interpretive statements are explicitly stated to be "on an advisory basis only," suggesting that human experts remain responsible for final diagnosis.

4. Adjudication method for the test set

Not applicable, as no clinical test set for diagnostic performance is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The non-clinical tests relate to hardware compliance and functional specifications.

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

The document does not describe a standalone performance study for the algorithm's diagnostic capabilities. The non-clinical tests performed were to verify that the device met design specifications and complied with safety and performance standards. The "CardioPro analysis program" is mentioned, and its interpretive statements are stated to be for "advisory basis only," indicating it's not intended for standalone diagnosis.

7. The type of ground truth used

Not applicable, as no clinical test set for diagnostic performance is described. The "ground truth" implicitly referred to in the non-clinical tests would be the established benchmarks and requirements defined by the IEC standards for technical performance (e.g., signal-to-noise ratio, frequency response).

8. The sample size for the training set

The document does not provide any information about a "training set" or explicit details on how the "CardioPro analysis program" was developed or trained.

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

Not applicable, as no information on a training set or its ground truth establishment is provided.

Summary

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Public Health Service

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

February 13, 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: K141946

Trade/Device Name: Digital electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 5, 2015 Received: January 15, 2015

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. Isting 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

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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 devicerelated 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 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

Enclosure

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Indications for Use

510(k) Number (if known) KJ41946

Device Name Digital Electrocardiograph

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PEEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IE NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect: of this information collection, including suggestions for reducing this burden, to:

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Section 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: K141946

1. Date of Submission: July 04, 2014
1. Sponsor Identification

Shenzhen Biocare Bio-Medical Equipment Co.,Ltd. #A735, Shenzhen Mingyou Industrial Product Exhibition & Procurement Center, Bao'an, Shenzhen, Guangdong, 518102, China

Establishment Registration Number: 3008457078

Contact Person: Mr. Hongbo Zhong Position: R&D Director Tel: +86-0755-36615333 Fax: +86-0755-27960643 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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4. Proposed Device Identification

Proposed Device Name: Digital Electrocardiograph; Models: iE 3, iE 6, iE 12, iE 12A, iE 15, ECG-1210, ECG-3010 and ECG-6010; Proposed Device Common Name: Electrocardiograph;

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

Intended Use Statement:

ર. Predicate Device Identification

510(k) Number: K091513 Product Name: Smart ECG (SE) Series Electrocardiograph, SE-12 Model: SE-12 Manufacturer: Edan Instruments, Inc

510(k) Number: K050858 Product Name: Ascentia HeartStation™ ECG Management System Manufacturer: Heartlab, Inc.

6. Device Description

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They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.

The CardioPro analysis program is the analysis program used in this proposed device.

Non-Clinical Test Conclusion 7.
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 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.

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

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 teats.

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8. Substantially Equivalent (SE) Conclusion

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	Predicate Device
		K091513	K050858
Model	iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/		N.A.
	ECG-1210/ECG-3010/	SE-12
	ECG-6010
Product Code	DPS	Same	Same
Regulation
Number	21CFR 870.2340	Same	Same
Intended Use			HeartStation™HeartlabTheECG
	Theintendeduseof	intendedTheuseof	Management System is a comprehensive data
	electrocardiograph is to acquire	electrocardiograph is to acquire	management solution which automates the
	ECG signals from adult and	ECG signals from adult and	processing,andstoragedisplayof
	pediatric patients through body	pediatric patients through body	electrocardiograms (ECGs)throughouta
	surface ECG electrodes. The	surface ECG electrodes. The	healthcare enterprise. HeartStation™ accepts
	electrocardiographisonly	electrocardiographisonly	standard 12-lead ECGs, which originate from
	intended to be used in hospitals	intended to be used in hospitals	any one of a variety of manufacturers'
	or healthcare facilities by doctors	healthcarefacilitiesorby	cardiographs and patient monitors, and
	andtrainedhealthcare	doctors and trained healthcare	them to a common format.normalizes
	professionals. The cardiogram	professionals. The cardiogram	ECGs arethen measured,interpreted,
	recordedbythe	recordedbythe	previouscomparedtoECGs("serial
	electrocardiographcanhelp	electrocardiograph canhelp	comparison"), optionally printed and stored
	users to analyze and diagnose	users to analyze and diagnose	with a preliminary diagnosis. A graphical user
	heart disease. However the ECG	heart disease. Howeverthe	interface allows a physician to review these
	withmeasurementsand	ECG with measurements and	computer-generated reports, modify them or
	interpretive statements is offered	interpretivestatementsis	add comments as appropriate, electronically
	to clinician on an advisory basis	offered to clinician onan	his or her signature and trigger theapply
	only.	advisory basis only.	automatic distribution of final, confirmed
			diagnostic reports to other care providers.
Lead	Standard 12-lead or 15 lead	Standard 12-lead	N.A.
Acquisition	Simultaneous 12-lead acquisition	Simultaneous12-lead	N.A.
mode	or 15 lead acquisition	acquisition
Recording	Automatic / Manual / Rhythm	Same	Unknown
format
Analysis mode	Yes	Yes	Yes
CMRR	>60dB	Similar	Unknown
	>100 with AC filter
Paper Speed	4 levels as 6.25, 12.5, 25,50mm/s, OR6 levels as: 5, 6.25, 10, 12.5, 25and 50mm/s	Similar	Unknown

Input CIRcurrent	≤0.1μΑ	Similar	Unknown

Input impedance	>50ΜΩ	Same	Unknown
Patient leakcurrent	<10μΑ	Same	Unknown

Frequencyresponse	0.05~150Hz	Same	Unknown

Noise level	<15μVp-p	Similar	Unknown
Electrical Safety	Comply with IEC 60601-1	Same	Same
EMC	Comply with IEC 60601-1-2	Same	Same
Particularrequirements	Comply with IEC 60601-2-25	Same	Unknown

Biocompatibility	Comply with ISO 10993	Same	N.A.

Table 3-1 Comparison of Technology Characteristics

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The proposed device, Digital Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate device, Smart ECG (SE) Series Electrocardiograph, SE-12 (K091513) and Ascentia HeartStation™ ECG Management System (K050858) 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).