(53 days)
Not Found
No
The document describes a standard electrocardiograph with measurement and interpretation functions, but there is no mention of AI or ML in the device description, intended use, or performance studies. The interpretation function is explicitly stated as advisory.
No
The device is used for acquiring ECG signals to help analyze and diagnose heart disease, which is a diagnostic function, not therapeutic.
Yes
The intended use statement explicitly states, "The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease." Although the interpretation is advisory, the device provides information for diagnostic purposes.
No
The device description explicitly details hardware components such as an ECG board, power supply board, keyboard, main board, screen, thermal printer, and battery. It is a physical electrocardiograph device, not software only.
Based on the provided information, the SE-1201 12-channel electrocardiograph is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- SE-1201's Function: The SE-1201 acquires ECG signals directly from the patient's body surface using electrodes. It does not analyze specimens derived from the body.
- Intended Use: The intended use clearly states it acquires ECG signals from adult and pediatric patients through body surface ECG electrodes.
- Device Description: The description focuses on the hardware and software for acquiring, displaying, and printing electrical signals from the heart.
Therefore, the SE-1201 falls under the category of a medical device used for physiological monitoring and diagnosis based on electrical signals from the body, not an IVD device that analyzes biological specimens.
N/A
Intended Use / Indications for Use
The intended use of SE-1201 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.
Product codes
DPS
Device Description
SE-1201 is 12-channel electrocardiograph, it's configured with a 7inch Multi-color screen with 800*480 dots resolution. SE-1201 is mainly composed of the ECG board, the power supply board, the Key board and the main board. SE-1201 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 Ethernet. SE-1201 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 (touch screen is optional) Real-time uploading to PC ECG Multiple file formats: DAT, PDF, SCP, FDA-XML 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).
0
510(K)Summary of Safety and Effectiveness MAR 1 6 2012
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: | Yue Qiuhong
Edan Instruments, Inc. |
| Date: | 2011-12-01 |
| Proprietary Name: | SE-1201 |
| 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 |
| Device Description: | SE-1201 is 12-channel electrocardiograph, it's configured
with a 7inch Multi-color screen with 800*480 dots resolution.
SE-1201 is mainly composed of the ECG board, the power
supply board, the Key board and the main board.
SE-1201 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 Ethernet.
SE-1201 has the features as follows:
Supporting barcode scanner
Supporting multi-language |
| 25 | |
| | ECG signals of 12 leads are gathered and amplified |
| | simultaneously, 12-channel waves are displayed and |
| | recorded simultaneously |
| | Full alphanumeric keyboard (touch screen is optional) |
| | Real-time uploading to PC ECG |
| | Multiple file formats: DAT, PDF, SCP, FDA-XML |
| | 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 |
| | net cable, or wireless AP (optional). |
| Intended Use: | The intended use of SE-1201 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-1201. |
| | ● Software testing |
| | ● Risk analysis |
| | ● Safety testing |
| | ● Environment testing |
1
Verification and validation testing was done on SE-1201. Conclusion: This pre-market notification submission demonstrates that SE-1201 is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
Edan Instruments c/o Ms. Tracy Yue Certification Engineer 3/F - B Nanshan Medical Equipments Park, Nanhai Rd 1019# Shenzhen Guangdong 518067 CHINA
Re: K120188
Trade/Device Name: SE-1201 Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: February 17, 2012 Received: February 21, 2012
Dear Ms. Yue:
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
3
Page 2 - Ms. Tracy Yue
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 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
SE-1201 Device Name:
The intended use of SE-1201 12-channel electrocardiograph is to acquire ECG signals from The micilaed are of of 92 02 02 through body surface ECG electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare mofessionals. The cardiogram recorded by the electrocardiograph can help users to analyze and prorose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
Over the Counter Use Or Prescription Use (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120188