ELECTROCARDIOGRAPH

K120188 · Edan Instruments, Inc. · DPS · Mar 16, 2012 · Cardiovascular

Device Facts

• Record ID: K120188
• Device Name: ELECTROCARDIOGRAPH
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Mar 16, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

SE-1201 is a 12-channel electrocardiograph featuring a 7-inch color screen and thermal printer. Device acquires ECG signals simultaneously via body surface electrodes; processes signals for display, storage, or printing; and provides automated measurements and interpretive statements. Operated by physicians or trained healthcare professionals in hospitals/clinics. Data can be stored in internal flash memory, printed, or transmitted to PC via Ethernet or optional wireless AP. Supports barcode scanning and multiple file formats (DAT, PDF, SCP, FDA-XML). Output provides clinicians with diagnostic data to assist in heart disease analysis; interpretations are advisory only. Benefits include real-time monitoring, flexible printing, and efficient data management.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including software testing, risk analysis, safety testing, and environmental testing.

Technological Characteristics

12-channel electrocardiograph; 7-inch color LCD (800x480); 216mm thermal printer; rechargeable lithium battery. Connectivity: Ethernet, optional wireless AP. Input: 12-lead ECG signals. Output: Waveforms, measurements, interpretive statements. Software includes measurement and interpretation functions. Standards: 21 CFR 870.2340.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition via body surface electrodes for heart disease analysis and diagnosis. Intended for use by doctors and trained healthcare professionals in hospitals or healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• MAC 5000 ECG Analysis System (K014108)

Submission Summary (Full Text)

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## 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<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: [phone]<br>Fax:[phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Yue Qiuhong<br>Edan Instruments, Inc. |
| Date: | 2011-12-01 |
| Proprietary Name: | SE-1201 |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph<br>Class II |
| Product code: | DPS |
| Predicate Devices: | MAC 5000 ECG Analysis System K014108<br>Manufacturer: GE medical systems information technologies |
| Device Description: | SE-1201 is 12-channel electrocardiograph, it's configured<br>with a 7inch Multi-color screen with 800*480 dots resolution.<br>SE-1201 is mainly composed of the ECG board, the power<br>supply board, the Key board and the main board.<br>SE-1201 can acquire 12 channel waveforms simultaneously,<br>which can also print out 12 channel electrocardiograph wave<br>simultaneously by a 216mm wide thermal printer, and the<br>waveforms also can be displayed in LCD and stored in flash<br>memory or send to PC by Ethernet.<br>SE-1201 has the features as follows:<br>Supporting barcode scanner<br>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 |

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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.

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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

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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 [phone] or [phone] 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

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## 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