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. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.

Device Description

The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.

The proposed electrocardiographs, iE 101 and iE 300, 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 one channel (iE 101) or three channel (iE 300).

AI/ML Overview

The provided text describes a 510(k) submission for a Digital Electrocardiograph, models iE101 and iE300. The submission argues for substantial equivalence to a predicate device (K141946).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria for diagnostic accuracy. The "acceptance criteria" here are essentially the compliance with relevant safety and performance standards and the demonstration that the proposed device performs similarly to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1:2005 + A1: 2012 (General safety)	Complies with IEC 60601-1:2005 + A1: 2012
Compliance with IEC 60601-1-2: 2007 (EMC)	Complies with IEC 60601-1-2: 2007
Compliance with IEC 60601-2-25:2011 (Electrocardiographs particular requirements)	Complies with IEC 60601-2-25:2011
Biocompatibility (ISO 10993)	Complies with ISO 10993
Intended Use	Same as predicate device
Intended Population	Same as predicate device (Adult and pediatric patients)
Intended Environment	Same as predicate device (Hospital, clinics)
Configuration	Same as predicate device
Lead	Same as predicate device (Standard 12-lead)
Acquisition mode	Same as predicate device (Simultaneous 12-lead acquisition)
Recording format	Same as predicate device (Automatic / Manual / Rhythm)
Analysis mode	Yes (Same as predicate, advisory basis only)
Physical/Technical Specifications (e.g., screen size, channels, battery capacity, noise level, CMRR)	Differences noted but deemed not to affect substantial equivalence (e.g., iE101: 5.0" screen, 1 channel; iE300: 5.0" screen, 3 channel vs. predicate's 6.0" screen, 3 channel). Software modified to be applicable to proposed devices.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set in the context of clinical performance evaluation based on patient data. The "tests" conducted were non-clinical, likely bench testing and engineering verification to demonstrate compliance with standards.

Sample Size for Test Set: Not applicable as no clinical test set was used.
Data Provenance: Not applicable as no clinical data was used for a test set. The non-clinical tests were conducted by the manufacturer (Shenzhen Biocare Bio-medical Equipment Co., Ltd.) in China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical study or test set requiring expert-established ground truth was performed for this submission. The device's "analysis feature" is offered on an advisory basis only, meaning its interpretive statements are not intended as definitive diagnoses.

4. Adjudication Method for the Test Set

Not applicable, as no clinical study or test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The submission explicitly states "No clinical study is included in this submission." Therefore, no MRMC study was conducted, and no effect size calculation for human readers with or without AI assistance is available.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device has an "analysis feature," the submission does not include any standalone performance study of this algorithm. The analysis feature provides "measurements and interpretive statements" on an "advisory basis only," indicating it's not cleared for diagnostic standalone use.

7. The Type of Ground Truth Used

Not applicable, as no clinical performance study requiring ground truth was conducted. For non-clinical tests (electrical safety, EMC, etc.), the "ground truth" would be the specifications and requirements of the relevant IEC standards.

8. The Sample Size for the Training Set

Not applicable. This device is an electrocardiograph hardware with an accompanying analysis feature. The submission does not describe a machine learning algorithm that underwent training with a specific dataset. The analysis function is likely based on pre-programmed algorithms rather than a trained AI model in the modern sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no described training set or AI model training in the submission.

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 12, 2016

Shenzhen Biocare Bio-medical Equipment Co., Ltd. Ms. Diana Hong General Manager P.O. Box 120-119 Shanghai, 200120 CN

Re: K160092

Trade/Device Name: Digital Electrocardiograph, iE101 and iE300 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 29, 2015 Received: January 15, 2016

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 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

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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 (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,

Mitchell Stein

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) K160092

Device Name Digital Electrocardiograph, iE101 and iE300

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K160092

Page 1 of 4

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K160092

1. Date of Preparation: 01/21/2016
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: +86-755-36615333 Fax: +86-755-27960643 Email: hb-zhong@tom.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

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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K160092

Page 2 of 4

Identification of Proposed Device 4.

Trade Name: Digital Electrocardiograph; Common Name: Electrocardiograph Models: iE 101 and iE300

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

Intended Use Statement:

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. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisorv basis only.

Device Description

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

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K160092 Page 3 of 4

module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).

న్. Identification of Predicate Device
510(k) Number: K141946 Product Name: Digital Electrocardiograph Model: iE 3
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 + A 1: 2012, Medical electrical equipment, Part 1: General requirements for safety.
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 tests.
A IEC 60601-2-25:2011, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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K160092 Page 4 of 4

8. Substantially Equivalent (SE) Comparison

Item	Proposed Devices	Predicate DeviceK141946
Model	iE 101/ iE 300	iE 3
Product Code	DPS	DPS
Regulation Number	870.2340	870.2340
Intended Use	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. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.	SAME
Intended Population	Adult and pediatric patients	SAME
Intended Environment	Hospital, clinics	SAME
Configuration	ECG main unitChest electrodes and Limb electrode	SAME
Lead	Standard 12-lead	SAME
Acquisition mode	Simultaneous 12-lead acquisition	SAME
Recording format	Automatic / Manual / Rhythm	SAME
Analysis mode	Yes	SAME
Screen size	5.0" (iE 101)5.0" (iE 300)	6.0"
Channel	1 channel (iE 101)3 channel (iE 101)	3 channel
Biocompatibility	Comply with ISO 10993	SAME
Electrical Safety	Comply with IEC 60601-1	SAME
EMC	Comply with IEC 60601-1-2	SAME
Particular requirements	Comply with IEC 60601-2-25	SAME

Table 1 Comparison of Technology Characteristics

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

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).