Digital Electrocardiographs, iE 12A / iE 15S, 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, iE 12A / iE 15 / iE 15S, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models. iE 12A / iE 15 / iE 15S, of the proposed device. Digital Electrocardiographs, follow · the same design principle and similar technical specifications.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Digital Electrocardiographs (models iE 12A, iE 15, iE 15S). The submission focuses on demonstrating substantial equivalence to a predicate device (iE 12) rather than presenting a study with specific acceptance criteria related to clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test and training sets for an AI algorithm, expert qualifications, adjudication methods, or MRMC study results, are not available in this document. This document primarily details the technical specifications and safety/EMC standards met by the device.

Here's a breakdown of what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to verifiable technical specifications and compliance with international standards for safety and electrical performance. The "reported device performance" in this context refers to the device meeting these technical specifications and standards.

ITEM	Acceptance Criteria (Predicate iE 12)	Proposed Device Performance (iE 12A / iE 15 / iE 15S)
Lead	Standard 12-lead	Standard 12-lead (iE 12A), Standard 12-lead/15-lead (iE 15, iE 15S)
Acquisition mode	Simultaneous 12-lead acquisition	Simultaneous 12-lead acquisition (iE 12A), Simultaneous 12-lead/15-lead acquisition (iE 15, iE 15S)
Recording format	Automatic / Manual / Rhythm	Automatic / Manual / Rhythm
Frequency response	0.05~150Hz	0.05 Hz~~150 Hz (iE 12A), 0.05 Hz~~250 Hz (iE 15, iE 15S)
Noise level	<15μVp-p	<15μVp-p
CMRR	>60dB, >100dB with AC filter	>60dB, >100dB with AC filter
Recording Speed	Six levels as 5, 6.25, 10, 12.5, 25, 50mm/s	Six levels as 5, 6.25, 10, 12.5, 25, 50mm/s
Input CIR current	≤0.1μΑ	≤0.1μΑ
Input impedance	>50ΜΩ	>50ΜΩ
External Input Impedance	≥100k Ω	≥100k Ω
External Input Sensitivity	10mm/V±5%	10mm/V±5%
External Output Impedance	≤100 Ω	≤100 Ω
External Output Sensitivity	1V/mV±5% (at 10mm/mV)	1V/mV±5% (at 10mm/mV)

Study Proving Acceptance Criteria Met:
The document states: "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: EN 60601-1, EN 60601-2-25, EN 60601-1-2, IEC60601-2-51."

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, which is verified by meeting technical specifications and compliance with relevant safety and performance standards. The differences in frequency response and lead type for the proposed devices compared to the predicate were addressed by conducting relative standard tests to demonstrate compliance.

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

Not applicable/Not provided within the scope of this document. This submission focuses on technical specifications and substantial equivalence, not a clinical study with a patient test set for diagnostic algorithm performance.

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

Not applicable/Not provided. No diagnostic algorithm performance study is described.

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

Not applicable/Not provided. No diagnostic algorithm performance study 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

No. This document pertains to the hardware and basic signal acquisition capabilities of an electrocardiograph, not an AI-assisted diagnostic system.

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

No. This document describes the ECG acquisition device itself, not a standalone diagnostic algorithm.

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

Not applicable/Not provided. The "ground truth" here is compliance with engineering standards and technical specifications shown via bench testing.

8. The sample size for the training set

Not applicable/Not provided. No machine learning algorithm is described.

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

Not applicable/Not provided. No machine learning algorithm is described.

In summary: This 510(k) submission is for a traditional Digital Electrocardiograph hardware device. The "acceptance criteria" and "study" described are focused on engineering specifications, electrical safety, and electromagnetic compatibility (EMC) through bench testing, to demonstrate substantial equivalence to a predicate device. It does not involve a clinical study to evaluate diagnostic performance of an AI algorithm.

Summary

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K123816 1/4

Premarket Notification 510(k) Submission

Project #:M0152012B Section III 510(k) Summary

FEB 2 7 2013

Section V 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 21 CFR 807.92.

The assigned 510(k) Number:

Date of prepared: Dec. 7, 2012
Sponsor

Shenzhen Biocare Electronics Co., Ltd 5/F, Taohuayuan High-Tech Innovation Park, Baoan Shenzhen, Guangdong, 518102, China

Establishment Registration Number: 3008457078

Contact Person: Mr. HongboZhong Position: Director Tel: +86-755-27960888 Fax: +86-755-27960643 Email: hb-zhong@tom.com

Submission Correspondent 3. Ms. Diana Hong & Mr. Tarzan Wang 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 Trade Name: Digital Electrocardiographs Proposed Device Common Name: Electrocardiographs Proposed Device Model: iE 12A / iE 15 / iE 15S Classification: Class II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular

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Intended Use Statement:

Digital Electrocardiographs, iE 12A / iE 15S. 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.

ડ. Predicate Device Identification
510(k) Number: K122712 Product Name: Digital Electrocardiograph / iE 12 Manufacturer: Shenzhen Biocare Electronics Co., Ltd
Device Description 6.
Digital Electrocardiographs, iE 12A / iE 15 / iE 15S, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models. iE 12A / iE 15 / iE 15S, of the proposed device. Digital Electrocardiographs, follow · the same design principle and similar technical specifications.

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:

EN 60601-1:1990+A1:1993+A11:1993+A12:1993+A2:1995+A13:1996, Medical electrical equipment - Part } : General requirements for safety.

EN 60601-2-25:1999, Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs.

EN 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and teats.

IEC60601-2-51:2003. Medical electrical equipment - Part 2: Particular requirements for the safety, including essential performance, of recording and analysing single channel and multi-channel electrocardiographs.

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Section III 510(k) Summary

Project #:M0152012B

		Proposed Device			Predicate Device
ITEM	Model	iE 12A	iE 15	iE 15S	iE 12
	Lead	Standard 12-lead	Standard12-lead/15-lead	Standard12-lead/15-lead	Standard 12-lead
	Acquisitionmode	Simultaneous 12-leadacquisition	Simultaneous12-lead/15-leadacquisition	Simultaneous12-lead/15-leadacquisition	Simultaneous12-lead acquisition
	Recordingformat	Automatic / Manual /Rhythm	Automatic / Manual /Rhythm	Automatic / Manual /Rhythm	Automatic /Manual / Rhythm
	Frequencyresponse	0.05 Hz~150 Hz	0.05 Hz~250 Hz	0.05 Hz~250 Hz	0.05~150Hz
	Noise level	<15μVp-p	<15μVp-p	<15μVp-p	<15μVp-p
	CMRR	>60dB>100dB with ACfilter	>60dB>100dB with AC filter	>60dB>100dB with ACfilter	>60dB>100dB with ACfilter
	RecordingSpeed	Six levels as 5, 6.25,10, 12.5, 25, 50mm/s	Six levels as 5, 6.25,10, 12.5, 25, 50mm/s	Six levels as 5, 6.25,10, 12.5, 25, 50mm/s	Six levels as 5,6.25, 10, 12.5,25, 50mm/s
	Input CIRcurrent	≤0.1μΑ	≤0.1μΑ	≤0.1μΑ	≤0.1μΑ
	Inputimpedance	>50ΜΩ	>50ΜΩ	>50ΜΩ	>50ΜΩ
	ExternalInput	Input impedance: ≥100k ΩSensitivity:10mm/V±5%	Input impedance: ≥100k ΩSensitivity:10mm/V±5%	Input impedance: ≥100k ΩSensitivity:10mm/V±5%	Input impedance:≥100k ΩSensitivity:10mm/V±5%
	ExternalOutput	Output impedance:≤100 ΩSensitivity: 1V/mV±5% (at 10mm/mV)	Output impedance: ≤100 ΩSensitivity: 1V/mV ±5% (at 10mm/mV)	Output impedance:≤ 100 ΩSensitivity: 1 V/mV±5%(at 10mm/mV)	Output impedance:≤100 ΩSensitivity: 1V/mV±5% (at10mm/mV )

Technological Characteristics Comparison 8.

Substantially Equivalent Conclusion 9.

We compared the proposed device with predicate device in product code, regulation number, class, intended use, performance, safety and EMC, the differences are frequency response and lead, for such differences we conducted relative standard to demonstrate such performance meet the

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Project #:M0152012B

requirements, the test result shown so.

The proposed device, Digital Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate device, Digital Electrocardiograph (K122712), in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

February 27, 2013

Shenzhen Biocare Electronics Co., Ltd c/o Ms. Diana Hong Submission Correspondent P.O. Box 237-023 Shanghai, 200237, China

Re: K123816

Trade Name: Digital Electrocardiographs Models iE 12A, iE 15 and iE 15S Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiographs Regulatory Class: Class II Product Code: DPS Dated: February 1, 2013 Received: February 5, 2013

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. Iisting 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 mav 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/Industrv/default.htm.

Sincerely yours,

Owen P. Faris -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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Premarket Notification 510(k) Submission

Section II Indications for Use

Project #:M0152012B

Section II Indications for Use

510(k) Number: Device Name:Digital Electrocardiographs

Indications for Use:

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D) O OVER-THE-COUNTER USÉ (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)

Page I of 1

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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).