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.

Device Description

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. 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.

AI/ML Overview

The provided text describes a 510(k) submission for the Aerotel Medical Systems "Heartline Receiving Station". However, it explicitly states that clinical tests were "Not required" and no specific acceptance criteria or performance studies were conducted to prove the device meets such criteria.

Therefore, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: Not provided, as clinical tests were not required. The submission only states the device was "thoroughly verified and validated" and the system "has been validated" but no performance metrics are given.
Sample sized used for the test set and the data provenance: Not applicable as no clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
Adjudication method for the test set: Not applicable as no clinical test set was used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as no clinical study was done and this device is described as a "software system" that displays data for "physicians analysis and comment," not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical performance study was done.
The type of ground truth used: Not applicable as no clinical performance study was done.
The sample size for the training set: Not applicable as no machine learning algorithm is described as being trained in a clinical context. The device is a "software system" for receiving and displaying ECG signals, not an AI model requiring a training set in the typical sense.
How the ground truth for the training set was established: Not applicable.

Summary of Device Performance and Basis for Acceptance:

The submission for the Heartline Receiving Station relies on non-clinical tests and substantial equivalence to a legally marketed predicate device (Aerotel Heartline receiving Console, K930314, cleared by FDA in 1993) rather than a clinical performance study with defined acceptance criteria.

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."

The FDA's decision to clear the device (K022073) was based on a finding of substantial equivalence to this predicate device, which implies that the new device is as safe and effective as the predicate and shares the same indications for use. The FDA letter confirms, "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...".

Therefore, the "acceptance criteria" were met by demonstrating that the device's design, software functionality, and intended use were comparable to an already cleared device, along with verification and validation of its non-clinical aspects (software programs, electrical safety, emissions). No specific performance metrics for diagnostic accuracy or clinical outcomes are provided or required in this submission context.

Summary

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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 201-727-1703 Fax 201-727-1708

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.

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

(Division Sign-Off)

Division of Cardiovascular and Respiratory Device

510(k) Number.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).