SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG Signal from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Device Description

PC ECG is a kind of resting and exercising electrocardiograph based on PC. PC ECG including data sampling modules and software which can be installed on desktop or laptop PC. PC ECG can acquire 12 channel waveforms simultaneously, which can also print out 3/6/12 channel electrocardiograph wave simultaneously by a 210mm (A4) wide printer. Advanced digital filter technique has been used in PC ECG including baseline anti-drift filter AC noise (50/60Hz) filter; EMG Filter and Low pass Filter which can help the user to record the ECG more clearly. Moreover. the ECG Measurement and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease.

AI/ML Overview

The provided text
{0} to {4} gives very limited information about the acceptance criteria and study proving device performance as it's a 510(k) summary, not a full study report. The available details are almost exclusively for the device itself and its general features, not for specific algorithm performance.

Here's an analysis based on the information provided, highlighting what can be answered and what cannot:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document mentions "Software testing," "Risk analysis," "Safety testing," and "Environment test" were applied. However, no specific performance metrics (e.g., accuracy, sensitivity, specificity for interpretation) are provided as acceptance criteria or results.
The device "can acquire 12 channel waveforms simultaneously."	"3/6/12-channel ECG wave display and printing simultaneously" is a feature.
The device "can also print out 3/6/12 channel electrocardiograph wave simultaneously by a 210mm (A4) wide printer."	"Report printing with PDF format, word format or JPG format" is a feature.
Advanced digital filter technique has been used, including baseline anti-drift filter AC noise (50/60Hz) filter, EMG Filter and Low pass Filter.	These filters are listed as being included.
The ECG Measurement and interpretation program (SEMIP) is included.	This program "can provide more detail information to diagnose heart disease." "Supporting auto measurement and diagnosing" is a feature.
The device is intended to acquire, process and store ECG signals from adult and pediatric patients.	No specific performance metrics for this are given.
The device recorded cardiogram can help users to analyze and diagnose heart disease.	The interpretive statements are "offered to clinicians on an advisory basis only."

Study Details

Sample size used for the test set and the data provenance: Not available. The document only states "Verification and validation testing was done on PC ECG" but provides no details on the test set, its size, or its origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. There is no information regarding ground truth establishment for a test set.
Adjudication method for the test set: Not available. No details about a test set or its adjudication are provided.
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: Not available. The submission does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The interpretation program "is offered to clinicians on an advisory basis only," suggesting it's a tool, not a replacement or direct comparison to human reading in this context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated/detailed. While the device includes an "ECG Measurement and interpretation program (SEMIP)" that supports "auto measurement and diagnosing," no standalone performance metrics for this algorithm are provided (e.g., diagnostic accuracy, sensitivity, specificity for specific conditions). The statement that these interpretations are "advisory" further suggests that rigorous standalone performance was not the primary focus of the 510(k) summary for interpretative accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available. Information on how ground truth was established for any performance evaluation is not provided.
The sample size for the training set: Not available. There is no information about a training set.
How the ground truth for the training set was established: Not available. There is no information about a training set or its ground truth establishment.

Summary of Limitations:

This 510(k) summary focuses on the safety and effectiveness (substantial equivalence) of the PC ECG device, rather than detailed performance metrics of its interpretive algorithms. It largely describes the device's features and general testing (software, risk, safety, environment). For an interpretive ECG device, a full study report would typically include detailed performance characteristics like sensitivity, specificity, and accuracy for various ECG findings, often compared against a gold standard established by expert cardiologists. This information is absent from the provided document.

Summary

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K131819

P 1/2

510(K) Summary of Safety and Effectiveness

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

Submitter:	Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86755 26858736Fax:+86 755 26882223
Contact person:	Queena ChenEdan Instruments, Inc.
Date:	2013-5-16
Proprietary Name:	PC ECG
Classification Name:	21 CFR 870.2340 Electrocardiograph
Product code:	DPS
Predicate Devices:	PC ECG, Model SE-1010K102854Manufacturer: Edan Instruments, Inc.CG-7000DX-BT ECG Recorder/TransmitterK052556Card Guard Scientific Survival, LTD.
Device Description:	PC ECG is a kind of resting andexercisingelectrocardiograph based on PC. PC ECG including datasampling modules and software which can be installed ondesktop or laptop PC. PC ECG can acquire 12 channelwaveforms simultaneously, which can also print out 3/6/12channel electrocardiograph wave simultaneously by a210mm (A4) wide printer.Advanced digital filter technique has been used in PC ECGincluding baseline anti-drift filter AC noise (50/60Hz) filter;EMG Filter and Low pass Filter which can help the user to

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record the ECG more clearly.

Moreover. the ECG Measurement and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease.

PC ECG has the features as follows:

-3/6/12-channel ECG wave display and printing simultaneously

-ECG wave frozen and review

-Measurement point adjustment and re-analyzing, manual measurement with high precision electronic ruler

-data management and processing function

-Report printing with PDF format, word format or JPG format

-Multi-language supporting

-Supporting auto measurement and diagnosing

-Automatic baseline adjustment for optimal printing

Intended Use: SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Test Summary:

The following quality assurance measures were applied to the development of the PC ECG Electrocardiograph

Software testing .
Risk analysis .
� Safety testing
. Environment test

Conclusion:

Verification and validation testing was done on PC ECG. This premarket notification submission demonstrates that PC ECG is substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 22, 2013

Edan Instruments, Inc. c/o Ms. Queena Chen Certification Engineer Equipments Park, Nanhai Rd 1019 No. Shekou Nanshan Shenzhen, 518067 CH

Re: K131819

Trade/Device Name: PC ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: June 17, 2013 Received: October 10, 2013

Dear Ms. Queena Chen:

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.

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Page 2 - Ms. Queena Chen

.. .

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 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, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131819

Indication for Use

510(k) Number: K131819

Device Name: PC ECG

× Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Digitally signed by
Owen P. Faris -5
Date: 2013.11.22
12:43:57-05'00'

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).