(64 days)
Not Found
No
The document describes a standard electrocardiograph with measurement and interpretive statements, but there is no mention of AI or ML in the device description, intended use, or performance studies. The interpretive statements are explicitly stated as advisory, which is typical for traditional ECG analysis algorithms, not necessarily indicative of AI/ML.
No.
The device is described as an electrocardiograph intended to acquire ECG signals for analysis and diagnosis, but it does not perform any therapeutic intervention itself.
Yes
The device is intended to help users analyze and diagnose heart disease, and the recorded cardiogram with measurements and interpretive statements is offered to clinicians, indicating its use in aiding diagnosis.
No
The device description explicitly mentions hardware components such as an "ECG board, power supply board and main controlling board," a "216mm wide thermal printer," an "LCD," and "flash memory." It also describes acquiring signals through "body surface ECG electrodes." These are all physical components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to acquire ECG signals from the body surface. This is a physiological measurement taken directly from the patient, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the hardware and software for acquiring, displaying, and printing ECG waveforms. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures typically associated with in vitro diagnostics.
In summary, the SE-12 series is an electrocardiograph, which is a medical device used for non-invasive physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
DPS
Device Description
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.
SE-12 series has the features as follows:
Supporting barcode scanner
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
§ 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).
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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: +86755 26882220
Fax:+86755 26882223 | DEC 2 2010 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact person: | Yue Qiuhong
Edan Instruments, Inc. | |
| Date: | 2010-9-25 | |
| Proprietary Name: | Electrocardiograph
models SE-12/SE-1200/SE-12Express/SE-1200Express | |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph
Class II | |
| Product code: | DPS | |
| Predicate Devices: | MAC 5000 ECG Analysis System K014108
Manufacturer: GE medical systems information technologies
SMART ECG SERIES ELECTROCARDIOGRAPH
K091513 Manufacturer: Edan Instruments, Inc | |
| Device Description: | 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 | |
1
SE-12 series Special 510k SUBMISSION
28
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
તું.
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
2
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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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ا سف ساب
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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
5
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