CARDIOVISION SOFTWARE, MODEL S-CV5-96

K981807 · Shl Telemedicine International , Ltd. · DPS · Aug 19, 1998 · Cardiovascular

Device Facts

• Record ID: K981807
• Device Name: CARDIOVISION SOFTWARE, MODEL S-CV5-96
• Applicant: Shl Telemedicine International , Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Cardio Vision software is intended for use by trained medical staff for visualization and measurement of ECG recordings to be used in the monitoring of a patient's cardiac condition together with knowledge of the patient's general condition and other medical data on record.

Device Story

Cardio Vision Software is a PC-based application for displaying and storing ECG recordings. It receives digital ECG signals from an ECG receiving center via a serial port; the receiving center obtains data from ECG recording devices via direct connection or telephone. The software interprets digital signals to display real-time single or multiple lead ECG plots on a screen. It allows storage of ECG data to disk, comparison with previous patient recordings, and performance of measurements on ECG plots. Used in clinical settings by trained medical staff, the software assists in monitoring cardiac conditions by providing visual data and measurements to support clinical decision-making alongside other patient medical records.

Clinical Evidence

Clinical evidence consisted of a comparison between Cardio Vision Software printouts and simultaneous ECG strip chart output. The study demonstrated that the software processes and presents ECG data consistently and accurately. Bench testing verified data sampling and processing modules using artificial signals and confirmed proper display scaling using prepared files.

Technological Characteristics

PC-based software; serial port connectivity for ECG data input; real-time display of single or multiple lead ECG plots; digital signal interpretation; data storage and measurement capabilities.

Indications for Use

Indicated for use by trained medical staff for the visualization and measurement of ECG recordings to monitor a patient's cardiac condition.

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

• Micromedical Cardioview Transtelephonic Software (k955891)
• Instromedix Cardiomagic Software (k925639)

Submission Summary (Full Text)

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AUG 20 1998

Image /page/0/Picture/1 description: The image shows the logo for SHL TeleMedicine International Ltd. The logo features the letters "SHL" in a stylized font, with a heart symbol in place of the "O". Below the letters, the words "TeleMedicine International Ltd." are printed in a smaller, sans-serif font. The logo appears to be printed in black ink on a white background.

K981807

# 510(k) Summary of Safety and Effectiveness

SHL Telemedicine International Ltd. Submitter Information: 90 Yigal Alon St. Tel Aviv, 67891 lsrael tel: [phone]

fax: [phone]

Proprietary Name and Model: Cardio Vision Software

FDA/CDRH/ODE/DAG

21 May 98

1526

Common/Usual Name: ECG Display and Storage Software

Classification Name: Electrocardiograph (21 CFR 870.2340)

Predicate Device: The predicate devices are the Micromedical Cardioview Transtelephonic Software (k955891) and the Instromedix Cardiomagic Software (k925639).

### Device Description:

The Cardio Vision software is a program which runs on a personal computer and is used for the display and storage of Electrocardiogram recordings. The software receives an input signal containing the ECG data from an ECG receiving center. The receiving center is connected to the computer on which the Cardio Vision software is running via a serial port. The ECG receiving center receives the ECG signal from an ECG recording device either via direct connection or via telephone. The software interprets the digital signal and displays it on the screen in real time as a single or multiple lead ECG plot.

The received ECG signal can be stored on the disk and can be compared to previous ECG recordings for that patient. In addition, measurements can be performed on the ECG plot.

### Intended Use:

The Cardio Vision software is intended for use by trained medical staff for visualization and measurement of ECG recordings to be used in the monitoring of a patient's cardiac condition together with knowledge of the patient's general condition and other medical data on record.

### Comparison to Predicate Device:

The Cardio Vision Software has the same intended use, basic features, and target population as its predicate devices. The Cardio Vision Software and its predicate devices all display, store, and enable convenient analysis of

TEL: [phone] FAX: [phone]

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E-MAIL: [e-mail] http://www.shahal.co.il

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Image /page/1/Picture/0 description: The image shows a logo for a company called "SHL TeleMedicine International Ltd." The letters "SHL" are in a large, bold font at the top of the image. There is a heart symbol in the middle of the letters. The words "TeleMedicine" and "International Ltd." are in a smaller font below the letters.

ECG signals received via a serial port from a locally or transtelephonically connected ECG receiving center.

### Safety:

The risk of all identified potential safety hazards is reduced by software design and testing and by the use of the device only by trained medical staff.

### Bench Data:

An artificial signal was fed into the receiving center, and the resulting ECG data was displayed and written to a log file. Comparison of the log file with the original signal verified that the data sampling and data processing modules function properly.

Using the ECG display module to display data from prepared files verified that the data was displayed properly and in the correct scale.

# Clinical Data:

The comparison of Cardio Vision Software printouts with simultaneous ECG strip chart output demonstrated that the Cardio Vision Software processes and presents ECG data consistently and accurately.

## Substantial Equivalence:

The safety and effectiveness of the Cardio Vision software are similar to that of its predicate devices. It is SHL's opinion that the Cardio Vision software is substantially equivalent to its legally marketed predicate devices in terms of safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 19 1998

Mr. Alroy Yariv Vice President SHL Telemedicine International, Ltd. 90 Yiqal Alon Street TEL AVIV, ISRAEL

K981807 Re : CardioVision Software Model S-CV5096 Requlatory Class: II (Two) Product Code: DPS Dated: May 21, 1998 Received: May 21, 1998

Dear Mr. Yariv

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 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). You mav. 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth 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. Alroy Yariv

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahion

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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1981807 510(k) Number (if known):

Device Name: _CARDIO VISION SOFT WARE

Indications For Use:

VISUALIZATION AND MEASUREMENT OF ECG BY TRAINED USED RECORDINGS TO BE MEDICAL CONDITION. MON | TORING CARDIAC IN THE OF STAFF

(Please do not write below this line-continue on another page if needed)

(Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Üse (Per 21 CFR 801.109)

OR

Over-The-Counter Use