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. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only

Device Description

The Smart ECG (SE) Series Electrocardiograph is designed to acquire, analyze, display, and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, The ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer or USB printer. ECG data, result and information of patient may be stored in the memory file. The file can be transmitted to PC through UART or Ethernet. Also the device can configure with the auto analysis software as optional which help to carry out auto measurement and auto interpretation. These devices consist of two basic components: the signal acquisition module and central processing unit. Models provide rechargeable battery. The SE Series Electrocardiograph can be divided into two type devices, SE-3, SE-300 series and SE-12, SE-1200 series. SE-3, SE-300 series are three channels Electrocardiograph, Including SE-300A, SE-300B, SE-3 (configuration with A and configuration with B ) , it can print out three channel electrocardiograph wave simultaneously by an 80mm wide thermal line printer. The difference between SE-3 and SE-300 is the device sheIl. SE-12, SE-1200 series are twelve or six channel Electrocardiograph, including SE-12, SE-12Express, SE-6, SE-1200, SE-1200Express, SE-600, it can print out twelve or six channel electrocardiograph wave simultaneously by a 216mm wide thermal line printer. the difference between SE-12 and SE-1200 is the device shell. The SE series Electrocardiograph is not intended to use in the emergency monitoring room.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments Electrocardiograph:

The provided 510(k) summary for the Edan Instruments, Inc. Electrocardiograph (SE series) does not contain explicit details about specific quantitative acceptance criteria or a detailed clinical study proving device performance against such criteria. It largely focuses on substantial equivalence based on technological characteristics and general quality assurance measures.

The document indicates that the device's auto-analysis software and auto-interpretation features are optional and offered on an advisory basis only. This limits the need for a rigorous clinical performance study for these features as they are not presented as definitive diagnostic tools. The core approval focuses on the device's ability to acquire, analyze (measurements), display, and record ECG signals.

Without specific performance data, it's impossible to create the requested table of acceptance criteria and reported performance or answer several of the detailed questions about study design. However, I can extract what is provided and explain the limitations.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not specify quantitative acceptance criteria for performance metrics like sensitivity, specificity, accuracy for interpretations, or specific measurement tolerances. Therefore, a table for these cannot be created from the given text.

The document states:

"Verification and validation testing was done on the SE Electrocardiograph."
"This premarket notification submission demonstrates that the SE Electrocardiograph is substantially equivalent to the cleared MAC 5000 because this device has the same basic intended use and the differences in technological characteristics do not raise new questions of safety or effectiveness."

This suggests the device met general safety and performance standards equivalent to its predicate, but no specific performance metrics are given.

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

The document does not provide any information about the sample size of a test set, nor the data provenance (e.g., country of origin, retrospective or prospective) for any performance evaluation. This type of information would typically be found in a detailed clinical study report, which is not present here.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not specify a number of experts, their qualifications, or how ground truth was established for any performance test set. Given the "advisory basis only" statement for interpretations, a less stringent ground truth establishment might have been deemed acceptable, or the focus was primarily on signal acquisition accuracy, for which a different type of "ground truth" (e.g., comparison to a reference ECG machine) would be used.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor does it provide any effect size for human readers improving with or without AI assistance. The optional "auto analysis software" and "auto interpretation" are presented as advisory, not as a tool designed to augment human reader performance in a clinical trial setting detailed here.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The document does not explicitly describe a standalone performance study of the interpretation algorithm. While it mentions "auto analysis software as optional which help to carry out auto measurement and auto interpretation," no performance metrics for this standalone algorithm are provided. The "advisory basis only" statement suggests its performance might not have undergone a standalone clinical validation for diagnostic accuracy.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing. Given the primary function is ECG signal acquisition and measurement, the "ground truth" might have been based on established ECG measurement standards and comparison to a predicate device's measurement accuracy, rather than clinical outcomes or pathology for interpretive accuracy.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set of the auto-analysis software.

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

The document does not provide any information about how the ground truth for the training set of the auto-analysis software was established.

Summary of Device and Approval Context:

The Edan Instruments Electrocardiograph received 510(k) clearance based on substantial equivalence to the MAC 5000 ECG Analysis System. The approval focuses on the device's ability to acquire, analyze (measurements), display, and record ECG signals. The auto-analysis and auto-interpretation features are presented as optional and advisory only, which likely reduced the regulatory burden for clinical performance studies specifically validating their diagnostic accuracy. The documentation emphasizes general quality assurance measures (software, hardware, safety, EMC testing) rather than detailed clinical performance studies of interpretive algorithms.

Summary

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JUL 2 4 2009

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, Inc 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China Tel: 86-755-26882220 Fax:86-755-26882223 Contact person: Jiang Yucai

Official correspondent:

Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 914 376-6111-Fax:

William Stern

Date of Preparation:	4/21/2009
Proprietary Name:	Electrocardiograph
Common Name:	Electrocardiograph
Classification Name:	21 CFR 870.2340 ElectrocardiographDPSClass II
Predicate Devices:	MAC 5000 ECG Analysis SystemK014108
Device Description:	The Smart ECG (SE) Series Electrocardiogacquire, analyze, display, and record ECG signal

graph is designed to als from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, The ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer or USB printer. ECG data, result and information of patient may be stored in the memory file. The file can be transmitted to PC through UART or Ethernet. Also the device can configure with the auto analysis software as optional which help to carry out auto measurement and auto interpretation.

These devices consist of two basic components: the signal acquisition module and central processing unit. Models provide rechargeable battery.

The SE Series Electrocardiograph can be divided into two type

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devices, SE-3, SE-300 series and SE-12, SE-1200 series,

SE-3, SE-300 series are three channels Electrocardiograph, Including SE-300A, SE-300B, SE-3 (configuration with A and configuration with B ) , it can print out three channel electrocardiograph wave simultaneously by an 80mm wide thermal line printer. The difference between SE-3 and SE-300 is the device sheIl.

SE-12, SE-1200 series are twelve or six channel Electrocardiograph, including SE-12, SE-12Express, SE-6, SE-1200, SE-1200Express, SE-600, it can print out twelve or six channel electrocardiograph wave simultaneously by a 216mm wide thermal line printer. the difference between SE-12 and SE-1200 is the device shell.

The SE series Electrocardiograph is not intended to use in the emergency monitoring room.

Intended Use

Contraindications;

None known at this time

Technology:

The technological characteristics of the SE-12 device have been updated to reflect use of current technology and to incorporate user-requested features. Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness.

Test Summary:

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

· Software testing
· Hardware testing
· Safety testing

· Electric Magnetic Compatibility testing

Conclusion:

Verification and validation testing was done on the SE Electrocardiograph. This premarket notification submission demonstrates that the SE Electrocardiograph is substantially

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equivalent to the cleared MAC 5000 because this device has the same basic intended use and the differences in technological characteristics do not raise new questions of safety or effectiveness.

91513

....

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2009

Edan Instruments, Inc. c/o Mr. William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, NY 10701

Re: K091513

SE series Electrograph (models: SE-3, SE-300A, SE-300B, SE-6, SE-600, SE-12, SE-12Express, SE-1200, SE-1200Express) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: July 07, 2009 Received: July 09, 2009

Dear Mr. Stern:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. William Stern

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); good manufacturing practice requircments 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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K0915/3

Re: K091513

Attachment 3

Indication for Use

510(k) Number (if known):K091513

Device Name: SE series Electrocardiograph (models: SE-3, SE-300A, SE-300B, SE-6, SE-600, SE-12, SE-12Express, SE-1200, SE-1200Express)

Prescription Use × (21 CFR Part 801 Subpart D)

And/Or

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

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

Zith Stei for Buckerman

(Division Sign-Off) Division of Cardiovascular Dev 510(k) Number 09151

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).