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, E30, E65, E70 and E80, 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. There is no specific contraindication identified for the proposed devices.

The proposed devices 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.

The components of the proposed devices, Digital Electrocardiograph, include: (1) chest electrodes (2) limb electrodes, (3) cable and (4) Batteries;

AI/ML Overview

The provided text is a 510(k) Summary for a Digital Electrocardiograph. It describes the device's intended use, comparison to a predicate device, and non-clinical tests conducted to establish substantial equivalence. However, it does not contain any information regarding specific acceptance criteria for device performance, a study proving the device meets these criteria, or details about sample sizes, ground truth establishment, or expert involvement as requested.

The summary primarily focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and compliance with general safety and performance standards (like IEC 60601-1 and AAMI EC11).

Therefore, based only on the provided text, I cannot fulfill most of your request.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Information in text: The document states the device complies with certain standards (IEC 60601-1, IEC 60601-1-2, AAMI / ANSI EC11:1991/(R)2007, ISO 10993-5, ISO 10993-10). These standards define performance requirements, but the specific acceptance criteria and reported device performance against these criteria are not detailed in the summary. The text only mentions "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that it "complies with the following standards."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information in text: Not available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Information in text: Not available. The device "can help users to analyze and diagnose heart disease," implying human interpretation, but no details of an expert-adjudicated test set are provided.

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

Information in text: Not available.

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

Information in text: Not available. This device is an electrocardiograph for acquiring ECG signals, not an AI-assisted diagnostic tool discussed in the context of MRMC studies.

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

Information in text: Not available. The device is described as acquiring signals
and assisting users in analysis and diagnosis, not a standalone automated diagnostic algorithm.

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

Information in text: Not available.

8. The sample size for the training set

Information in text: Not available. (No mention of a training set for an algorithm).

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

Information in text: Not available. (No mention of a training set for an algorithm).

Summary of available information related to performance/acceptance criteria:

Acceptance Criteria (Standards Met)	Reported Device Performance
IEC 60601-1 (Safety)	Complies w/ standard
IEC 60601-1-2 (EMC)	Complies w/ standard
AAMI / ANSI EC11 (Diagnostic ECG Devices)	Complies w/ standard
ISO 10993-5 (Cytotoxicity)	Non-Cytotoxicity
ISO 10993-10 (Irritation/Hypersensitivity)	Non-Irritation, Non-Sensitization

Further Details:

Test Set Sample Size & Provenance: Not provided.
Experts for Ground Truth & Qualifications: Not provided.
Adjudication Method: Not provided.
MRMC Comparative Effectiveness Study: Not conducted/reported.
Standalone Performance Study: Not conducted/reported.
Type of Ground Truth Used: Not provided.
Training Set Sample Size: Not applicable/provided (device is for signal acquisition, not an AI diagnostic algorithm with a training set).
Training Set Ground Truth Establishment: Not applicable/provided.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (predicate device) by showing similar intended use, technological characteristics, and compliance with recognized performance and safety standards for electrocardiographs. It does not provide the kind of detailed clinical study data often found for AI/CADe devices.

Summary

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Section 3 510 Summary

Project #: M0202013 A

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:

1. Date of Submission: 6/11/2013
1. Sponsor Identification

Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Ms. Liang, Jing Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn

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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Premarket Notification 510(k) Submission

Project #: M0202013A

4. Proposed Device Identification

Proposed Device Name: Digital Electrocardiograph Models: E30, E35, E40, E65, E70 and E80 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:

1. Predicate Device Identification
  510(k) Number: K101876 Predicate Device Name: Digital Electrocardiographs Manufacturer: Shenzhen Biocare Electronics Co., Ltd

Device Description 6.

The components of the proposed devices, Digital Electrocardiograph, include: (1) chest electrodes (2) limb electrodes, (3) cable and (4) Batteries;

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7. 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:

ア 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 3:2007-03, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
AAMI / ANSI EC11:1991/(R)2007, Diagnostic electrocardiographic devices.
A ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Test for in vitro cytotoxicity;
ISO 10993-10:2002/A2006, Biological Evaluation of Medical Devices - Part 10: Tests for irritation and delayed-type hypersensitivity;
Substantially Equivalent (SE) Conclusion 8.

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(s)	Predicate Device(s)
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,ECG-1210 / ECG-1230 / ECG-3010/ECG-6010, are intended to acquireECG signals from adult andpediatric patients through bodysurface ECG electrodes. Theobtained ECG records can helpusers to analyze and diagnose heartdisease. Digital Electrocardiographsshall be used in healthcare facilitiesby doctors and/or trained healthcareprofessionals.
Patient Contact Material	ABS / Cooper Alloy	ABS / Tin Alloy

Table 3-1 Comparison of Technology Characteristics

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Section 3 510 Summary

Project #: M0202013 A

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
Biocompatibility	Non-Cytotoxicity	Non-Cytotoxicity
	Non-Irritation	Non-Irritation
	Non-Sensitization	Non-Sensitization
Performance	AAMI EC11	AAMI EC11
Accessories	Limb Electrode	Limb Electrode
	Chest Electrode	Chest Electrode
	Battery	Battery

The proposed devices, Digital Electrocardiographs, E30, E35, E70 and E80, are determined to be Substantially Equivalent (SE) to the predicate devices, Digital Electrocardiographs, ECG-120 / ECG-1230 / ECG-3010 /ECG-6010. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The image is black and white.

Public Health Service

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

June 11, 2014

Guangdong Biolight Meditech Co., Ltd. % Diana Hong Mid-Link Consulting Co., Ltd P.o. Box 120-119 Shanghai, 200120 CH

Re: K131858

Trade/Device Name: Digital Electrocardiograph (E30, E35, E40, E65, E70, E80) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 30, 2014 Received: May 5, 2014

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

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Page 2 - Diana Hong

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 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/ResourcesforYowIndustry/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,

Image /page/5/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and have a bold, geometric design. There are lines drawn through the logo, possibly indicating that it is not valid or has been rejected. The logo is in black and white.

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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K131858 Page 1 of 1

Section 2 Indications for Use

510(k) Number: Device Name: Digital Electrocardiograph Models: E30, E35, E40, E65, E70 and E80

Indications for Use:

Digital Electrocardiographs are intended to acquire ECG signals from adult and pediatric through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

☑PRESCRIPTION USE(Part 21 CFR 801 Subpart D)	OR	☐OVER-THE-COUNTER USE(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date
20.04.05.11
09.44.03 -04'00'

Page 1 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).