SE-601 SERIES ELECTROCARDIOGRAPH by EDAN INSTRUMENTS, INC.

The intended use of SE-601 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. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

Device Description

SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. Device features include as follows: Portable, lightweight design, Easy data input and operation, Alphanumeric keyboard and one-touch operation, Built-in rechargeable battery, AC/DC power supply, Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics, Two-step exercise test with periodic recording, Heart rate variability (HRV) analysis, Internal thermal printer and external printer, Support external archiving: USB flash disk, card reader, Data transmission to PC via Ethernet . WIFI or serial port.

AI/ML Overview

The provided text is a 510(k) summary for the SE-601 Series Electrocardiograph, indicating that the submission is to modify the intended use to include pediatric patients. The document outlines general testing performed but does not provide specific acceptance criteria or a detailed study proving the device meets those criteria based on clinical performance metrics for the diagnostic software.

Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:

1. Table of acceptance criteria and reported device performance:

This information is not present in the provided document. The summary mentions "Software testing," "Performance testing," "Safety testing," and "Environmental testing" were applied, and that "Verification and validation testing was done," leading to the conclusion of substantial equivalence. However, no quantitative acceptance criteria or performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for ECG interpretation) are given.

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

This information is not present in the provided document. The text does not detail any clinical test set used for evaluating the device's diagnostic software for adults or the newly added pediatric population.

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

This information is not present in the provided document.

4. Adjudication method for the test set:

This information is not present in the provided document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance:

This information is not present in the provided document. The device offers "Automatic analysis and diagnostic software (SEMIP)," but there's no mention of a comparative effectiveness study involving human readers. The interpretive ECG with measurements and statements is explicitly advisory only and not intended for pediatric patients, suggesting it's not designed to replace human interpretation, especially for diagnosis.

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

While the device has "Automatic analysis and diagnostic software (SEMIP)," the document does not provide details of any standalone performance study (e.g., sensitivity, specificity, accuracy) for this software, either for adults or for its (not yet approved for diagnosis) use in pediatrics. It only states that the interpreted ECG is advisory and only for adult patients.

7. The type of ground truth used:

This information is not present in the provided document. Given the lack of a detailed clinical study, the type of ground truth used to evaluate the diagnostic software's performance (e.g., expert consensus, pathology, outcomes data) is not specified.

8. The sample size for the training set:

This information is not present in the provided document. The document mentions the SEMIP software but does not detail how it was developed or trained.

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

This information is not present in the provided document.

In summary:

The provided 510(k) summary is primarily focused on demonstrating substantial equivalence to predicate devices for the device itself (acquiring ECG signals, physical characteristics, general software functionality like display and saving) and modifying its intended use to include pediatric signal acquisition. It does not present the detailed clinical performance data, acceptance criteria, or study methodologies that would be necessary to answer your specific questions regarding the diagnostic capabilities of the device's interpretive software. The interpretive software is explicitly noted as "advisory basis only" and "only intended to be used on adult patients." This strongly suggests that its diagnostic performance was not the primary focus of this specific 510(k) submission, or at least such detailed data is not included in this summary.

Summary

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510(K)Summary of Safety and Effectiveness

FEB 25 2014 This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92 The 510(k) number is (if known)_

Submitter:	Edan Instruments, Inc3/F - B. Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou. Nanshan Shenzhen,518067 P.R. ChinaTel: +86755 26882220Fax:+86 755 26882223
Contact person:	Cherry SunEdan Instruments, Inc.
Proprietary Name:	SE-601 Series Electrocardiograph
Classificationinformation:	21 CFR 870.2340, ElectrocardiographClass II
Product code:	DPS
Review Panel:	Cardiovascular
Predicate Devices:	PC ECG cleared under K092010Manufacturer: Edan Instruments, Inc.SE-601 series Electrocardiograph cleared under K093869Manufacturer: Edan Instruments, Inc.
Device Description:	SE-601 series Smart ECG includes three models SE-601A, SE-601Band SE-601C.Device features include as follows:
	● Portable, lightweight design● Easy data input and operation● Alphanumeric keyboard and one-touch operation● Built-in rechargeable battery, AC/DC power supply● Automatic analysis and diagnostic software (SEMIP) for adultsand pediatrics● Two-step exercise test with periodic recording● Heart rate variability (HRV) analysis

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Intended Use:

. Internal thermal printer and external printer
. Support external archiving: USB flash disk, card reader
. Data transmission to PC via Ethernet . WIFI or serial port

This submission is to modify the indication for use (intended use) by adding the applicable pediatric population.

Test Summary:

The following quality assurance measures were applied to the development of the SE-601 Series Electrocardiograph:

0 Software testing
0 Risk analysis
0 Safety testing
. Performance testing
. Environmental testing

Conclusion:

Verification and validation testing was done on SE-601 Series Electrocardiograph. This premarket notification submission demonstrates that the subject device SE-601 Series Electrocardiograph is substantially equivalent to the predicate device above mentioned

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

February 25, 2014

Edan Instruments, Inc. Ms. Cherry Sun Certification Engineer Nanhai Road 1019# Nanshen Shenzhen, Guangdong, China 518067

Re: K131503

Trade/Device Name: SE-601 Series Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 21, 2014 Received: January 28, 2014

Dear Ms. Cherry Sun:

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

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Page 2 - Ms. Cherry Sun

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 vours.

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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Indication for Use

510(k) Number:

Device Name: SE-601 Series Electrocardiograph

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)

Concur for B. Zuckerman

Date:
11/01/2014 14:02:25
13:39:48:05'00'

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).