PC ECG

K102854 · Edan Instruments, Inc. · DPS · Dec 3, 2010 · Cardiovascular

Device Facts

• Record ID: K102854
• Device Name: PC ECG
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG 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.

Device Story

PC-based resting and exercise electrocardiograph; acquires 12-channel ECG waveforms via body surface electrodes; utilizes data sampling modules and software installed on desktop/laptop PC. Features digital filtering (baseline anti-drift, AC noise, EMG, low pass) for signal clarity. Includes SEMIP (ECG and interpretation program) for automated measurement and diagnosis. Used in hospitals/healthcare facilities by physicians and trained professionals. Output includes 3/6/12-channel waveform display, printed reports (PDF/Word/JPG), and interpretive statements. Clinicians use advisory output to support heart disease diagnosis; enables waveform freezing, review, and manual measurement adjustments.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including software testing, risk analysis, safety testing, and environmental testing.

Technological Characteristics

PC-based system; 12-channel acquisition; digital filtering (baseline, AC, EMG, low pass); supports 3/6/12-channel printing on A4 paper; software-based analysis (SEMIP program); connectivity via PC interface.

Indications for Use

Indicated for adult and pediatric patients undergoing stress exercise or resting ECG tests to acquire, process, and store ECG signals for heart disease diagnosis.

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

• Cardiosoft/case cardiac testing system (K031561)
• PC ECG, MODEL SE-1010 (K092010)

Submission Summary (Full Text)

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PC ECG special 510k modification SUBMISSION

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24

DEC - 3 2010.'

# 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, 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 (Tracy)<br>Edan Instruments, Inc. |
| Date: | 2010-9-20 |
| Proprietary Name: | PC ECG |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph |
| Product code: | DPS |
| Predicate Devices: | Cardiosoft/case cardiac testing system<br>K031561<br>Manufacturer: GE medical systems information technologies<br>PC ECG, MODEL SE-1010<br>K092010<br>Manufacturer: Edan Instruments, Inc |
| Device Description: | PC ECG is a kind of resting and exercising<br>electrocardiograph based on PC. PC ECG including data<br>sampling modules and software which can be installed on<br>desktop or laptop PC. PC ECG can acquire 12 channel<br>waveforms simultaneously, which can also print out 3/6/12<br>channel electrocardiograph wave simultaneously by a<br>210mm (A4) wide printer.<br>Advanced digital filter technique has been used in PC ECG<br>including baseline anti-drift filter AC noise (50/60Hz) filter<br>EMG Filter and Low pass Filter, which can help the user to<br>record the ECG more clearly. |

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Measurement Moreover, the ECG and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease.

PC ECG has the features as follows:

। 3/6/12-channel ECG wave display and printing simultaneously

ECG wave frozen and review ।

Measurement point adjustment and re-analyzing, manual ー measurement with high precision electronic ruler

data management and processing function ।

Report printing with PDF format, word format or JPG ﺳﮯ format

Multi-language supporting ।

Supporting auto measurement and diagnosing -

- । Automatic baseline adjustment for optimal printing
### Intended Use:

SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG 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.

Test Summary:

The following quality assurance measures were applied to the development of the PC ECG Electrocardiograph

- Software testing ●
- Risk analysis .
- . Safety testing
- Environment test �

#### Conclusion:

Verification and validation testing was done on PC ECG. This premarket notification submission demonstrates that PC ECG is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the staff and a serpent intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

DEC - 3 2010

Re: K102854

> Trade/Device Name: PC ECG Model SE-1010 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 Qiuhong

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/ucm 1 1 5809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

[signature]

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

KID2854 510(k) Number (if known):

Device Name: PC ECG

SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

× Prescription Use Or Over the Counter Use (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

W.M.S

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DEC - 3 2010