The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.

The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.

Device Description

The Heart 2006 is a battery-powered ECG event recorder and transmitter that is capable of storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. It records a portion of the ECG both before and after a "Record" button is depressed.

The H2006 is a battery powered ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as Aerotel's Heartline Receiving Station (FDA # K022073) or equivalent. It records portions of the ECG both before and after the Record button is depressed.

AI/ML Overview

The provided text states that no clinical tests were performed for the Heart 2006 device. Therefore, a study proving the device meets acceptance criteria, as well as specific acceptance criteria related to clinical performance, a test set, expert involvement, and ground truth, cannot be described from this document.

The document indicates that the device's modifications were validated through non-clinical tests, specifically by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38. The conclusion drawn from these non-clinical tests was that the Heart 2006 is equivalent in safety and efficacy to its predicate device, Heart 2005.

Since no clinical study was conducted, the following information cannot be provided:

A table of acceptance criteria and the reported device performance: No clinical acceptance criteria are mentioned, and no clinical performance data is reported.
Sample size used for the test set and the data provenance: No clinical test set existed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set existed, thus no ground truth establishment by experts.
Adjudication method for the test set: No clinical test set existed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No clinical study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No clinical study was performed, and the device is a hardware event recorder, not an AI algorithm.
The type of ground truth used: No clinical ground truth was established.
The sample size for the training set: The device is a hardware event recorder, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable, as detailed above.

Summary

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OCT 03 2003

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Aerotel Medical Systems (1998) Ltd. Special 510(k) Heart 2006 Cardiac Event Recorder

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements Regulation par. 807.92, effective March 14, 1995.

1. Submitter

Name: Aerotel Medical Systems (1998) Ltd Address: 5 Hazoref St., Holon 58856, Israel Telephone Number: 972-3-5596111 Contact person: Dr. George Myers, 210-787- 1703 Date prepared: March 7, 2000

2. Device

Proprietary name: Heart 2006 Common Name: Electrocardiograph Event Recorder and Telephonic Transmitter Classification Name: Transmitters and Receivers, electrocardiograph, telephone

Predicate Device

Heart 2005. K000775. manufactured by Aerotel Medical Systems (1998) Ltd..

Description

Intended Use

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Aerotel H2006

physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.

The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.

Comparison

The Heart 2006 is a modified version of the predicate device. It has basically the same electrical and mechanical characteristics, and the use of the two devices by the patient is equivalent.

Performance Data

(1) Non-clinical tests

The modifications were validated by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38.

(2) Clinical Tests

No clinical tests were performed.

8. Conclusion

The conclusion drawn from these tests is that the Heart 2006 is equivalent in safety and efficacy to its predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2003

Aerotel Medical Systems (1998) Ltd. c/o George H. Myers, Sc.D. President Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re: K032736

Trade Name: Heart 2006 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: September 2, 2003 Received: September 4, 2003

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 - Dr. George Myers

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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

V. Valenti

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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Aerotel H2006 Recorder

Page 3

K032736

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Indications for Use Form

Device Name: Heart 2005

Indications for Use:

The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
Use
(Per 21 CFR 810.109)

Over-the-Counter

(Optional Format 1-2-96)

OaheTm

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).