(64 days)
SE-12 series is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-12 series is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-12 series 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.
SE-12 series is 12-channel electrocardiograph, it contains four models:SE-12/SE-1200/SE-12Express/SE-1200Express. These four models include the same ECG board, power supply board and main controlling board. The software and function of these four models are similar, except that SE-12Express has the optional function which include stress exercise test. SE-12 series can acquire 12 channel waveforms simultaneously, which can also print out 12 channel electrocardiograph wave simultaneously by a 216mm wide thermal printer, and the waveforms also can be displayed in LCD and stored in flash memory or send to PC by RS232 or Ethernet.
This document is a 510(k) summary for the Edan Instruments SE-12 series Electrocardiograph, a Class II medical device. It outlines the device's description, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed performance metrics, or a dedicated study section that directly addresses the acceptance criteria in the manner requested. The document primarily focuses on establishing substantial equivalence to previously cleared devices.
Based on the provided text, here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly list acceptance criteria with corresponding performance statistics. Instead, it relies on a "Test Summary" stating: "The following quality assurance measures were applied to the development of the SE-12 series: Software testing, Risk analysis, Safety testing, Environment test." It concludes: "Verification and validation testing was done on SE-12 series. This premarket notification submission demonstrates that SE-12 series is substantially equivalent to the predicate device."
To fulfill this request fully, detailed performance specifications and acceptance criteria would typically be found in the full 510(k) submission, not just the summary. Without that, we can only infer that the acceptance criteria revolved around meeting safety, performance, and functional requirements comparable to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test sets, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective nature).
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)
The document does not mention the number or qualifications of experts used to establish ground truth for any test set. The intended use states that the interpreted ECG is "offered to clinicians on an advisory basis only," implying human expert review is still central to diagnosis, but it doesn't detail how ground truth was established for testing the device's interpretation function itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device, an electrocardiograph, pre-dates widespread AI interpretation in medical devices, dating back to 2010. Its interpretation function is likely rule-based rather than AI-driven.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that the "interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only." This clearly indicates that the device's interpretation function is not intended for standalone use in diagnosis and requires human-in-the-loop performance. Therefore, a standalone performance study in the context of diagnostic interpretation is not implied or described. The "Test Summary" only mentions general software, risk, safety, and environment testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for any testing. Given the "advisory basis" for interpretation, it's highly likely that if interpretation accuracy was assessed, it would have been against expert consensus readings, but this is not explicitly stated.
8. The sample size for the training set
The document does not provide information regarding a training set sample size. This is consistent with the device being from 2010 and its interpretation likely relying on rule-based algorithms rather than machine learning models that require explicit training sets in the modern sense.
9. How the ground truth for the training set was established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
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510(K)Summary of Safety and Effectiveness
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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 26882220Fax:+86755 26882223 | DEC 2 2010 |
|---|---|---|
| Contact person: | Yue QiuhongEdan Instruments, Inc. | |
| Date: | 2010-9-25 | |
| Proprietary Name: | Electrocardiographmodels SE-12/SE-1200/SE-12Express/SE-1200Express | |
| Classification Name: | 21 CFR 870.2340 ElectrocardiographClass II | |
| Product code: | DPS | |
| Predicate Devices: | MAC 5000 ECG Analysis System K014108Manufacturer: GE medical systems information technologiesSMART ECG SERIES ELECTROCARDIOGRAPHK091513 Manufacturer: Edan Instruments, Inc | |
| Device Description: | SE-12 series is 12-channel electrocardiograph, it containsfour models:SE-12/SE-1200/SE-12Express/SE-1200Express.These four models include the same ECG board, powersupply board and main controlling board. The software andfunction of these four models are similar, except thatSE-12Express has the optional function which include stressexercise test. SE-12 series can acquire 12 channel waveformssimultaneously, which can also print out 12 channel |
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SE-12 series Special 510k SUBMISSION
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electrocardiograph wave simultaneously by a 216mm wide thermal printer, and the waveforms also can be displayed in LCD and stored in flash memory or send to PC by RS232 or Ethernet.
SE-12 series has the features as follows:
Supporting barcode scanner
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Supporting multi-language
ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves are displayed and recorded simultaneously
Full alphanumeric keyboard
(For SE-1200Express and SE-12Express, touch screen is available)
Real-time uploading to PC ECG
Multiple file formats
High resolution thermal recorder, recording frequency response ≤150Hz
Flexible printing formats
The auto, manual, rhythm, R-R analysis and off modes can be chosen freely
Automatic baseline adjustment for optimal printing Convenient operation of system setup and file management Measurement function and interpretation function Hint information of lead off, lack of paper, low battery
capacity etc. Built-in rechargeable lithium battery with large capacity
ECG data can be transmitted to the PC software through the serial cable, net cable, or wireless AP (optional).
The following features are only for the exercise stress test function of SE-12 Express (optional)
Real-time analysis, ST segment and trend are applied while sampling:
Real-time display and print of 12-lead simultaneous ECG waveforms:
ST segment analysis while sampling; ST position is adjustable while sampling;
Providing average templates of three rhythm leads in every stage to observe the change of ST segments between every two stages
Automatically forming elaborate reports, including Summary
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| Report, ST Scope Report and Trend Graph Report | |
|---|---|
| Providing classical exercise protocols; exercise protocols can be edited and created. | |
| Automatically controlling and adjusting the speed and grade of the treadmill or the power of the bicycle | |
| Supporting multi-types of treadmill or bicycle | |
| Intended Use: | The intended use of the SE-12 series (12-channel 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 interpreted 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 SE-12 series.Software testing Risk analysis Safety testing Environment test |
| Conclusion: | Verification and validation testing was done on SE-12 series. This premarket notification submission demonstrates that SE-12 series is substantially equivalent to the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 2010
Edan Instruments, Inc. c/o Ms. Yue Qiuhong Registrar 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019# Shekou, Nanshan Shenzhen, 518067 P.R. China
Re: K102830 Trade/Device Name: SE Series Electrocardiograph (Models SE-12, SE-1200, SE12Express, SE-1200Express) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 28, 2010 Received: November 8, 2010
Dear Ms. Qiuhong:
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 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. Yue Oiuhong
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
S 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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510(k) Number (if known): K102830
Device Name: Electrocardiograph models SE-12/SE-1200/SE-12Express/SE-1200Express
Indication for Use
SE-12 series is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-12 series is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-12 series 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.
Prescription Use (21 CFR Part 801 Subpart D) Ог
Over the Counter Use (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
W.M.S.
vascular Devices
510(k) Number K102830
§ 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).