Digital Electrocardiographs 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 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.

AI/ML Overview

The provided text is a 510(k) summary for Digital Electrocardiographs (models iE 3, iE 6) and a letter from the FDA determining their substantial equivalence to a predicate device (iE 12). This document does not contain information about specific acceptance criteria, device performance metrics, or details of a study demonstrating the device meets such criteria.

The core of this document is a comparison between the proposed devices and a predicate device to establish "substantial equivalence," meaning that the new devices are as safe and effective as a legally marketed device. This is a regulatory pathway, not a clinical study demonstrating performance against specific benchmarks.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or directly stated from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy for disease detection). The acceptance criteria, in the context of this 510(k), are primarily related to meeting design specifications and demonstrating substantial equivalence to the predicate device, especially regarding safety and intended use.
Reported Device Performance: No specific numerical performance metrics are reported in this document. The document states a "Non-Clinical Test Conclusion" that "Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1, IEC 60601-1-2." This refers to electrical safety and electromagnetic compatibility standards, not clinical performance for diagnosing heart disease.

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

Sample Size: Not mentioned.
Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not mentioned, as a clinical study with ground truth established by experts is not detailed here.

4. Adjudication Method

Not mentioned.

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

If done: No, an MRMC comparative effectiveness study is not described or referenced in this document. This submission focuses on establishing substantial equivalence to a predicate device based on technical characteristics and intended use, not on demonstrating improved human reader performance with AI assistance.
Effect size of human readers improvement: Not applicable, as no such study is presented.

6. Standalone (Algorithm Only) Performance Study

If done: No, a standalone performance study of an algorithm is not described or referenced. The device is a "Digital Electrocardiograph" which acquires, displays, and records ECG signals for users (doctors/trained professionals) to analyze and diagnose. While it "can help users to analyze and diagnose heart disease," the document does not detail an inherent diagnostic algorithm's performance.

7. Type of Ground Truth Used

Not mentioned, as no clinical study requiring a ground truth is detailed.

8. Sample Size for the Training Set

Not mentioned, as this document does not describe the development or training of an AI algorithm.

9. How Ground Truth for the Training Set Was Established

Not mentioned, as this document does not describe the development or training of an AI algorithm.

Summary of what the document does provide:

Device Models: iE 3, iE 6
Intended Use: To acquire ECG signals from adult and pediatric patients through body surface ECG electrodes, with obtained records helping users to analyze and diagnose heart disease. To be used in healthcare facilities by doctors and/or trained healthcare professionals.
Predicate Device: Digital Electrocardiographs, iE 12 (K122712)
Regulatory Basis for Acceptance: Substantial Equivalence (SE) to the predicate device, demonstrated through non-clinical tests verifying compliance with design specifications and international safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
Key Comparison Points for SE: Intended use, technological characteristics, principles of operation, patient contact material, sterile/single use status, energy source, safety standards, and accessories are deemed equivalent to the predicate device.

Summary

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JAN 30 2014

Section 10 510(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: K132758

10.1 Date of Submission: 08/30/2013

10.2 Sponsor Identification

Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Room A735, Floor 7, Tower A, Shenzhen Famous Industrial Products Procurement & Exhibition Center No. 168, Baoyuan Road, Bao'an, Shenzhen, Guangdong, 518102, China

Establishment Registration Number: 3008457078

Contact Person: Mr. HongboZhong Position: R&D Director Tel: +86-0755-36615333-8856 Fax: +86-0755-27960643 Email: hb-zhong@tom.com

10.3 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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Premarket Notification 510(k) Submission

10.4Proposed Device Identification

Proposed Device Name: Digital Electrocardiograph Models: iE 3.iE 6 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:

10.5 Predicate Device Identification

510(k) Number:K 122712

Predicate Device Name: Digital Electrocardiographs, iE12

Manufacturer: Shenzhen Biocare Electronics Co., Ltd

10.6Device Description

10.7 Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed 10-2

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device complies with the following standards:

A IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; . Amendment 1. 1991-11, Amendment 2, 1995:
IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.

10.8 Substantially Equivalent (SE) Conclusion

The following table compares the DEVİCE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device
Model	iE 3	iE 12
Product Code	DPS	DPS
Regulation Number	870.2340	870.2340
Intended Use	Digital Electrocardiographs areintended to acquire ECG signalsfrom adult and pediatric patientsthrough body surface ECGelectrodes. The obtained ECGrecords can help users to analyzeand diagnose heart disease. DigitalElectrocardiographs shall be usedin healthcare facilities by doctorsand/or trained healthcareprofessionals.	Digital Electrocardiographs areintended to acquire ECG signalsfrom adult and pediatric patientsthrough body surface ECGelectrodes. The obtained ECGrecords can help users to analyzeand diagnose heart disease. DigitalElectrocardiographs shall be used inhealthcare facilities by doctorsand/or trained healthcareprofessionals.
Patient Contact Material	ABS / Tin Alloy	ABS / Tin Alloy
Sterile	No	No
Single Use	No	No
Energy Source	AC Power / DC Power	AC Power / DC Power
Safety	IEC 60601-1 / IEC 60601-1-2	IEC 60601-1 / IEC 60601-1-2
Accessories	Limb ElectrodeChest ElectrodeBattery	Limb ElectrodeChest ElectrodeBattery

Table 3-1 Comparison of Technology Characteristics between iE 3 and iE 12

10-3

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Premarket Notification 510(k) Submission

Item	Proposed Device(s)	Predicate Device
		K122712
Model	iE 6	iE 12
Product Code	DPS	DPS
Regulation Number	870.2340	870.2340
Intended Use	Digital Electrocardiographs areintended to acquire ECG signalsfrom adult and pediatric patientsthrough body surface ECGelectrodes. The obtained ECGrecords can help users to analyzeand diagnose heart disease. DigitalElectrocardiographs shall be usedin healthcare facilities by doctorsand/or trained healthcareprofessionals.	Digital Electrocardiographs areintended to acquire ECG signalsfrom adult and pediatric patientsthrough body surface ECGelectrodes. The obtained ECGrecords can help users to analyzeand diagnose heart disease. DigitalElectrocardiographs shall be used inhealthcare facilities by doctorsand/or trained healthcareprofessionals.
Patient Contact Material	ABS / Tin Alloy	ABS / Tin Alloy
Sterile	No	No
Single Use	No	No
Energy Source	AC Power / DC Power	AC Power / DC Power
Safety	IEC 60601-1 / IEC 60601-1-2	IEC 60601-1 / IEC 60601-1-2
Accessories	Limb ElectrodeChest ElectrodeBattery	Limb ElectrodeChest ElectrodeBattery

Table 3-2 Comparison of Technology Characteristics between iE 6 and iE 12

10.9 SE Conclusion

The proposed devices, Digital Electrocardiographs, iE 3 and iE 6, are determined to be Substantially Equivalent (SE) to the predicate devices, Digital Electrocardiographs, iE 12.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

ood and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2014

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

Re: K132758

Trade/Device Name: Digital electrocardiograph models iE 3 and iE 6 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 21, 2013 Received: January 3, 2014

Dear Ms. 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 11 (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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-

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Page 2 - Ms. Diana Hong

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/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 2 Indications for Use Project #: M0602013

Section 2 Indications for Use

and/or trained healthcare professionals.

510(k) Number:
Device Name: Digital Electrocardiograph
Indications for Use: iE 3, iE 6

Page I of I

PRESCRIPTION USE
(Part 21 CFR 801 Subpart D)
OR
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)

Digi
Owe
Date
15-2

Digitally signed by Owen P. Faris -5 Date: 2014.01.30 1 5:21:59 -05/00/

2- I

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).