HEARTLINE RECEIVING STATION

K022073 · Aerotel Medical Systems (1998) , Ltd. · DXH · Jul 24, 2002 · Cardiovascular

Device Facts

• Record ID: K022073
• Device Name: HEARTLINE RECEIVING STATION
• Applicant: Aerotel Medical Systems (1998) , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Heartline Receiving Station is indicated for use when patients transmit electrocardiographic signals from remote cardiac ECG event recorders to a central station.

Device Story

Heartline Receiving Station (HRS) receives ECG signals transmitted over standard telephone lines from patient-operated remote cardiac event recorders. The system, operating on commercial PCs, decodes incoming signals, records the data, and displays ECG waveforms on a monitor. Physicians access the displayed data to perform analysis and provide comments. The device facilitates remote cardiac monitoring, allowing healthcare providers to review patient ECG data without requiring the patient to be physically present in the clinic. This supports timely clinical decision-making based on transmitted cardiac events.

Clinical Evidence

No clinical data provided; bench testing only. The system software was verified and validated to ensure performance and compatibility with standard commercial PCs meeting international electrical safety and electronic emission standards.

Technological Characteristics

Software-based system operating on commercial personal computers. Receives ECG signals via standard telephone lines. Compatible with Aerotel ECG monitors. Connectivity via standard telephone infrastructure. No specific hardware materials or proprietary sensing hardware described; system relies on software decoding of transmitted signals.

Indications for Use

Indicated for patients requiring remote transmission of electrocardiographic (ECG) signals from cardiac event recorders to a central station for physician review.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Aerotel Heartline receiving Console (K930314)

Submission Summary (Full Text)

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Aerotel Medical Systems (1998) Ltd. Special 510(k) Submission Heartline Receiving Station

# 510(k) Summary

## (1) Submitter Information

Name: Aerotel Medical Systems (1998) Ltd.

Address:

5 Hazoref Street 58858 Holon Israel

Telephone Number: 972-3-559-6111

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: June 19, 2002

(2) Name of Device

Trade Name: Heartline Receiving Station Common Name: Electrocardiographic Telephone Event Receiver/Transmitter Classification name: Transmitters and Receivers, Electrocardiograph, Telephone 74 KGJ.

# (3) Equivalent legally-marketed devices.

Aerotel Heartline receiving Console, K930314

## (4) Description

The Heartline is an ECG monitoring device intended to receive ECG signals

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# Aerotel Heartline

Page A2

over standard telephone lines from patient operated transmitters. When decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. The HRS is basically a software system, and operates on commercial personal computers. The device is compatible with all Aerotel monitors, all of which have been cleared by the FDA.

(5) Intended Use

The Heartline Receiving Station is indicated for use when patients transmit electrocardiographic signals from remote cardiac ECG event recorders to a central station.

### (6) Performance Data

(a) Non-clinical tests

The programs for the Heartline Receiving Station have been thoroughly verified and validated. The recommended computers meet international standards for electrical safety and electronic emissions.

The entire system has been validated.

(b) Clinical tests

Not required.

(c) Conclusions

The Heartline Receiving Station is equivalent in safety and efficacy to the legallymarketed predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

### Public Health Service

JUL 2 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aerotel Medical Systems c/o George H. Myers, Sc.D. President Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re: K022073

Trade Name: Heartline Receiving Station Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulation Number: 21 CFR 870.2920 Regulatory Class: Class II (two) Product Code: DXH Dated: June 24, 2002 Received: June 26, 2002

### Dear Dr. Myers:

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 - George S. Myers, Sc.D.

ース アドリア アイディース イベント (イン) イベント) ヘルドアーター (1) (1) ) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) 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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Della Till

onna-Bea 7 illman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Aerotel Heartline

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Indications for Use Form

Device Name: Heartline Receiving Station

# Indications for Use:

"The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters when decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. "

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Prescription Use
(Per 21 CFR 801.109)

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(Division Sign-Off)

Division of Cardiovascular and Respiratory Device

510(k) Number.