(63 days)
Not Found
No
The description mentions "auto analysis software as optional which help to carry out auto measurement and auto interpretation," but this is a common feature in ECG devices and does not necessarily indicate the use of AI/ML. There is no mention of AI, ML, deep learning, or related terms.
No.
The device's intended use is to acquire ECG signals to help analyze and diagnose heart disease; it does not mention treating or curing any conditions.
Yes
The device helps users analyze and diagnose heart disease and provides interpretive statements, which are characteristics of a diagnostic device.
No
The device description explicitly mentions hardware components such as a signal acquisition module, central processing unit, LCD, thermal printer, USB printer, and rechargeable battery. It is a physical electrocardiograph device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The "in vitro" part means "in glass" or "in a test tube," referring to tests performed outside of the living organism.
- Device Function: The described electrocardiograph acquires ECG signals directly from the patient's body surface using electrodes. This is a non-invasive procedure that measures electrical activity within the body. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use is to acquire ECG signals and help users analyze and diagnose heart disease based on these signals. This is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, based on the provided information, the Smart ECG (SE) Series Electrocardiograph is a medical device, but it falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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
Product codes
DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals or healthcare facilities by doctors and trained healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Electrocardiograph |
| DPS | |
| Class II | |
| Predicate Devices: | MAC 5000 ECG Analysis System |
| K014108 | |
| Device Description: | The Smart ECG (SE) Series Electrocardiog |
| acquire, 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
1
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
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
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
2
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)
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
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