PC ECG, MODEL SE-1010

K092010 · Edan Instruments, Inc. · DPS · Oct 22, 2009 · Cardiovascular

Device Facts

• Record ID: K092010
• Device Name: PC ECG, MODEL SE-1010
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 22, 2009
• 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 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 electrocardiograph (SE-1010) acquires ECG signals via body surface electrodes; samples, displays, and stores data on PC; supports 3/6/12-channel simultaneous display/printing. Features include waveform freezing, review, auto-measurement, and diagnostic templates. Used in hospitals/healthcare facilities by physicians and trained professionals. Output provided as digital reports (PDF, Word, JPG) or screen display. Clinicians use advisory measurements and interpretive statements to assist in heart disease diagnosis. System allows manual measurement adjustment and re-analysis via electronic ruler.

Clinical Evidence

Bench testing only. Verification and validation testing performed, including software testing, risk analysis, safety testing, and environmental testing.

Technological Characteristics

PC-based ECG system; 3/6/12-channel acquisition; software-based auto-measurement and diagnostic algorithms; connectivity via PC interface; supports multiple file formats (PDF, Word, JPG).

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition via body surface electrodes for heart disease analysis and diagnosis by healthcare professionals.

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)

Submission Summary (Full Text)

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K092010
20 page 1 of 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] | OCT 22 2009 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact person: | Jiang yucai<br>Edan Instruments, Inc. | |
| Date: | 2009-6-29 | |
| Proprietary Name: | PC ECG | |
| Classification Name: | 21 CFR 870.2340 Electrocardiograph | |
| Product code: | DPS | |
| Predicate Devices: | Cardiosoft/case cardiac testing system<br>Manufacturer: GE medical systems information technologies<br>K031561 | |
| Device Description: | PC ECG including model SE-1010 has the similar functions<br>of an ordinary electrocardiograph. ECG data can be sampled,<br>displayed and stored in PC machine, and they can be printed<br>with several kinds of printing types, including PDF format,<br>word format and JPG format. ECG wave can be frozen and<br>reviewed. Auto measurement and diagnosing is available,<br>and Diagnose Template can be edited.<br>PC ECG has the features as follows:<br>- 3/6/12-channel ECG wave display and printing simultaneously<br>- ECG wave frozen and review<br>- Measurement point adjustment and re-analyzing, manual measurement with high precision electronic ruler | |

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- 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 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:

Conclusion:

The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

OCT 22 2009

Edan Instruments, Inc. c/o Mr. William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, NY 10701

Re: K092010

> PC ECG Model SE-1010 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: Undated Received: September 17, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.

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/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/ResourcesforYou/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): K 092010

Device Name: PC ECG

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.

Prescription Use

Or

Over the Counter 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 K092 010