PC ECG

K131819 · Edan Instruments, Inc. · DPS · Nov 22, 2013 · Cardiovascular

Device Facts

• Record ID: K131819
• Device Name: PC ECG
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Nov 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

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.

Device Story

PC ECG is a PC-based system for resting and stress exercise ECG testing. It utilizes data sampling modules and software installed on a desktop or laptop PC to acquire 12-channel waveforms simultaneously. The system employs digital filters (baseline anti-drift, AC noise, EMG, low pass) to enhance signal clarity. The SEMIP program provides automated measurement and interpretation of ECG data. Features include wave freezing, review, manual measurement via electronic ruler, and report generation in PDF/Word/JPG formats. Used in hospitals and healthcare facilities by physicians and trained professionals. Output is provided on an advisory basis to assist clinicians in diagnosing heart disease.

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

PC-based diagnostic system; 12-channel simultaneous acquisition; digital filtering (baseline, AC, EMG, low pass); supports 3/6/12-channel printing; software-based ECG measurement and interpretation (SEMIP); connectivity via PC interface; compatible with standard A4 printers.

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

• PC ECG, Model SE-1010 (K102854)
• CG-7000DX-BT ECG Recorder/Transmitter (K052556)

Submission Summary (Full Text)

{0}------------------------------------------------

K131819

## P 1/2

# 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<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: | Queena Chen<br>Edan Instruments, Inc. |
| Date: | 2013-5-16 |
| Proprietary Name: | PC ECG |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph |
| Product code: | DPS |
| Predicate Devices: | PC ECG, Model SE-1010<br>K102854<br>Manufacturer: Edan Instruments, Inc.<br>CG-7000DX-BT ECG Recorder/Transmitter<br>K052556<br>Card Guard Scientific Survival, LTD. |
| Device Description: | PC ECG is a kind of resting and<br>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 |

{1}------------------------------------------------

record the ECG more clearly.

Moreover. the ECG Measurement 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 measurement with high precision electronic ruler

-data management and processing function

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

-Multi-language supporting

-Supporting auto measurement and diagnosing

-Automatic baseline adjustment for optimal printing

Intended Use: 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.

#### 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 devices.

{2}------------------------------------------------

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 22, 2013

Edan Instruments, Inc. c/o Ms. Queena Chen Certification Engineer Equipments Park, Nanhai Rd 1019 No. Shekou Nanshan Shenzhen, 518067 CH

Re: K131819

> Trade/Device Name: PC ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: June 17, 2013 Received: October 10, 2013

Dear Ms. Queena Chen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{3}------------------------------------------------

Page 2 - Ms. Queena Chen

.. .

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

**Owen P. Faris -S**

for

Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### K131819

## Indication for Use

510(k) Number: K131819

Device Name: PC ECG

SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG Signal 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 (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

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

Or

Digitally signed by
Owen P. Faris -5
Date: 2013.11.22
12:43:57-05'00'