Digital Electrocardiograph is 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 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 document is a 510(k) premarket notification for a Digital Electrocardiograph, Model: ECG-2000. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets acceptance criteria derived from a novel clinical trial.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in the context of a clinical performance study with specific metrics like sensitivity, specificity, accuracy, etc. Instead, it demonstrates compliance with technical specifications and safety standards to establish substantial equivalence. The "performance" reported is primarily in terms of meeting these engineering and safety benchmarks.

Feature	Predicate Device 1 (K092010)Description / Value	Proposed Device (ECG-2000)Reported Performance
Product Code	DPS	DPS (Same)
Regulation Number	21 CFR 870.2340	21 CFR 870.2340 (Same)
Class	Class II	Class II (Same)
Intended Use	Acquire ECG signals from adult patients to help analyze and diagnose heart disease. Used by healthcare professionals.	Acquire ECG signals from adult and pediatric patients to help analyze and diagnose heart disease. Used by healthcare professionals. (Similar: extended to pediatric patients)
Configuration	Chest Electrode and Limb Electrode	Chest Electrode and Limb Electrode (Same)
ECG Lead	Standard 12-lead	Standard 12-lead (Same)
ECG Gain	(Implied range from "Similar" to proposed device)	1.25, 2.5, 5, 10, 20, 10-5, 20-10 (mm/mV) (More options than Predicate 1, Same as Predicate 2)
Sampling rate	1000Hz	1000Hz (Same)
Input circuit current	(Implied value from "Similar" to proposed device, complies with IEC 60601-1)	$\leq$ 0.1 μA (Complies with IEC 60601-1)
Noise level	(Implied value from "Similar" to proposed device, complies with IEC 60601-1)	$<15\mu$ Vp-p (Complies with IEC 60601-1)
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1 (Same)
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2 (Same)
Patient-contact Material	Chest Electrode: Metal, Limb Electrode: ABS	Same

Note on "Intended Use": The proposed device extends its intended use to include pediatric patients, whereas Predicate Device 1 explicitly mentions "adult patients" in the comparison table. Predicate Device 2, however, is the exact same device, and its previous clearance (K133985) likely covered adult patients, and this submission seeks to add pediatric. The document explicitly states: "This submission is filed for extension of intended use...therefore, only the following standard was tested to verify that the device can meet its additional intended use: IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs."

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

Sample Size: Not applicable. The document states "No clinical study is included in this submission." The testing primarily involved product verification to standards (e.g., IEC 60601-2-25) rather than a clinical evaluation with a test set of patient data.
Data Provenance: Not applicable, as no clinical data set was used for performance evaluation in this submission.

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

Not applicable. No clinical test set requiring ground truth established by experts was used.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

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. The device is a "Digital Electrocardiograph," which primarily acquires and displays ECG signals for analysis by healthcare professionals. It does not appear to incorporate AI for interpretation or act as an AI-assistive tool for human readers, nor was an MRMC study conducted.

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

The document implies the device performs basic signal acquisition, filtering, and amplification, displaying these signals for human interpretation. There is no mention of an "algorithm" performing diagnostic interpretations in a standalone capacity that would require specific performance testing against a ground truth. The device "can help users to analyze and diagnose heart disease," which suggests it provides raw or processed signals for expert review, not an automated diagnosis.

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

Not applicable. No clinical performance evaluation requiring a ground truth was conducted. The "ground truth" here is implied by the technical specifications and adherence to international standards for electrocardiographs.

8. The sample size for the training set

Not applicable. This device is an acquisition and display system for ECG signals. There's no indication it employs machine learning or AI that would require a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design element below them.

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

December 18, 2015

Shenzhen Biocare Bio-medical Equipment Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K152384

Trade/Device Name: Digital Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: November 6, 2015 Received: November 9, 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, 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 of medical device

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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 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

forBram 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) K152384

Device Name Digital Electrocardiograph, ECG-2000

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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Tab #7 510(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:

1. Date of Preparation: 08/04/2016
1. 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, 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. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (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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4. Identification of Proposed Device

Trade 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:

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

Device Description

ર . Identification of Predicate Device(s)

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

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Predicate device 2 510(k) Number: K133985 Product Name: Digital Electrocardiograph, ECG-2000 Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

1. Non-Clinical Test Conclusion
  This submission is filed for extension of intended use, the device, including its hardware and software, has not been changed from the one cleared in the previous submission, K133985; therefore, only the following standard was tested to verify that the device can meet its additional intended use:

IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device	PredicateDevice1	PredicateDevice 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 heartdisease. Digital Electrocardiographshall be used in healthcare facilitiesby doctors and/or trained healthcareprofessionals.	Same	Similar
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

Table 1 Comparison of Technology Characteristics

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Input circuit current	$\leq$ 0.1 μA	Similar	Same
Noise level	$<15\mu$ Vp-p	Similar	Same
Electrical Safety	Comply with IEC 60601-1	Same	Same
EMC	Comply with IEC 60601-1-2	Same	Same
Patient-contact	Chest Electrode: Metal	Same	Same
Material	Limb Electrode: ABS	Same	Same

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.

Substantially Equivalent (SE) Conclusion 9.
The proposed device, Digital Electrocardiograph EG-2000, is determined to be Substantially Equivalent (SE) to the predicate devices, PC ECG (K092010) and Digital Electrocardiographs ECG-2000 (K133985), 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).