EASY ECG PC BASED ELECTROCARDIOGRAPH

K972996 · Ates Medical S.R.L. · DPS · Apr 28, 1998 · Cardiovascular

Device Facts

• Record ID: K972996
• Device Name: EASY ECG PC BASED ELECTROCARDIOGRAPH
• Applicant: Ates Medical S.R.L.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers. It is consisting of intelligent tracing modules which can be connected to a PC's serial port and software for displaying and printing on any laser or inkjet printer. East ECG acquired simultaneously 12 leads for 4/8 seconds and then display the tracing on the monitor's screen.

Device Story

Easy ECG is a PC-based electrocardiograph system; consists of hardware modules connecting to a PC serial port and software for signal processing. Device acquires 12-lead ECG signals simultaneously for 4 or 8 seconds; displays tracings on a PC monitor; enables printing via standard laser or inkjet printers. Used by physicians and cardiologists in clinical settings to leverage existing computer hardware for cardiac monitoring. Output allows clinicians to visualize and interpret ECG data to support cardiac diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based electrocardiograph; connects via serial port; 12-lead simultaneous acquisition; 4/8 second recording duration; software-based display and printing; compatible with standard laser/inkjet printers.

Indications for Use

Indicated for use by physicians and cardiologists to record and visualize 12-lead ECG tracings using a personal computer. Prescription use only.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1998

Mr. Michael Davidson ATES Medical S.R.L. c/o Futuremed America Inc. 15700 Devonshire Street Granada Hills, CA 91344-7225

K972996 Re : Easy ECG PC Based Electrocardiograph Regulatory Class: II (two) 74 DPS Product Code: Dated: April 6, 1998 ---Received: April 8, 1998

Dear Mr. Davidson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as setforth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Michael Davidson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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-+ CDRH ODE

**REMED**

Futuremed America Inc. 15700 Devonshire Street Granada Hills. CA 91344-7225 USA

Telephone: [phone] Fax: [phone]

K 972996

## INDICATION FOR USE

Subject: 510(k) Number K972996 Product: PC Based Electrocardiograph Device : Easy ECG

Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers. It is consisting of intelligent tracing chrough personal completed to a PC's serial port and software for modules witch can be comeoser cing on any laser or inkjet printer.

East ECG acquired simultaneously 12 leads for 4/8 seconds and then display the tracing on the monitor's screen.

The advantage of PC Based EAST ECG is enabling physicians and cardiologists to use it with existing computers.

M. P

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_

Prescription Use ✓
(Per 21 CFR 801.109)