The TelZuit Cardiac Monitoring System consists of a 4-channel ECG (electrocardiograph) monitor (TelZuit Electrode Array Patch) and the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder stores and transmits data received from the TelZuit Electrode Array Patch via telephone to a remotely located ECG analysis station for evaluation by a medical professional.

Device Description

The TelZuit Cardiac Monitoring System is a transtelephonic ambulatory ECG recorder consisting of the TelZuit Electrode Array Patch and TelZuit Cardiac Monitoring Recorder. These components, when used together, allow a patient to collect and transmit their ECG data to an analysis station for evaluation by a medical professional.

The TelZuit Electrode Array Patch is a multi-layer patch containing four embedded ECG electrodes and leads and a transmitter mounted on a Mylar substrate that is affixed to the patient's chest for monitoring ECG activity. Two models, Models A and B, are available that differ in lead placement and configuration. The electrode configuration in the TelZuit Electrode Array Patch Model A corresponds to positions of Lead I, Lead II, Lead III, and V2 for use with 12 Lead Algorithms. The electrodes in the TelZuit Electrode Array Patch Model B are positioned orthogonally so that the leads correspond to positions of EASI & G for use with Modified Frank Algorithms.

Each TelZuit Electrode Array Patch model is supplied in different sizes with lengths of 8.0, 8.5, 9.0, and 9.5 inches (203, 216, 229, 241 mm). The electrodes incorporated in all versions of the TelZuit Electrode Array Patch are identical to electrodes cleared for marketing by Bristol Medical Electronics, Inc., (K841944) and comply with ANSI/AAMI EC 12, "Disposable ECG Electrodes."

The TelZuit Cardiac Monitoring Recorder captures and stores digitized ECG data transmitted from the TelZuit Electrode Array Patch, and transmits this information to a remotely located receiving and analysis station via a modified Samsung Portable Dualband Tri-Mode personal digital assistant (PDA) with cellular telephone The device has a touchscreen LCD display. Recording and capabilities. transmission of ECG data occurs continuously while the TelZuit Electrode Array Patch and TelZuit Cardiac Monitoring Recorder are active. The patient may also record a cardiac event via the LCD display screen on the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder also continuously monitors the operational status of the TelZuit Cardiac Monitoring System and informs the user if an error is detected.

AI/ML Overview

The provided 510(k) summary for the TelZuit Cardiac Monitoring System does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets particular performance metrics. Instead, it relies on general statements about compliance with industry standards and demonstration of accurate ECG tracing reproduction, primarily focusing on establishing substantial equivalence to predicate devices.

However, based on the information provided, we can infer some aspects and present the available data.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance
ECG Tracing Reproduction	ECG tracings can be accurately and reliably reproduced from the signals transmitted by the TelZuit Cardiac Monitoring System.
Compliance with Standards	The TelZuit Cardiac Monitoring System complies with recognized industry standards for ambulatory ECG electrocardiograph devices.
Electrode Compliance	The electrodes incorporated in all versions of the TelZuit Electrode Array Patch are identical to electrodes cleared for marketing by Bristol Medical Electronics, Inc., (K841944) and comply with ANSI/AAMI EC 12, "Disposable ECG Electrodes."

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance:

The document does not specify a particular sample size for a test set. The performance testing mentioned is broadly described, without details on the number of patients or recordings used.
The data provenance is not mentioned. It is unclear if the data was retrospective or prospective, or from which country/region.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information about experts involved in establishing ground truth for any test set, nor their qualifications. The system is designed for evaluation by a "medical professional," but this refers to the end-use scenario, not the validation study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not specify any adjudication method for a test set.

5. 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:

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a monitoring system that transmits raw ECG data for human evaluation, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this submission as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document does not describe a standalone algorithm performance study. The device functions as a data collection and transmission system, explicitly stating that data is sent "for evaluation by a medical professional." It is not an algorithmic diagnostic device, so a standalone algorithm performance would not be applicable to its stated function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not specify the type of ground truth used for any performance testing. Given the nature of an ECG monitoring system, ground truth would typically involve comparing the recorded ECG signals to a reference standard (e.g., a known, high-fidelity ECG capture system) or expert interpretation of the ECG waveforms themselves. However, these details are not provided.

8. The sample size for the training set:

This device does not appear to involve a machine learning algorithm that would require a "training set" in the conventional sense. It's a hardware system for data capture and transmission. Therefore, no training set size is applicable or mentioned.

9. How the ground truth for the training set was established:

As there is no apparent training set for a machine learning algorithm, no ground truth establishment method for a training set is applicable or mentioned.

Summary of Limitations in the Provided Information:

The 510(k) summary focuses heavily on establishing substantial equivalence based on intended use, general design, and compliance with recognized industry standards (like ANSI/AAMI EC 12 for electrodes). It does not delve into specific performance metrics, detailed study designs, sample sizes for validation, or the specifics of how "accurate and reliable reproduction" of ECG tracings was quantifiably demonstrated beyond a general statement. This type of submission, particularly for devices of this era (2003), often relied more on predicate device comparison and adherence to standards rather than extensive, quantitative clinical performance studies that are common for more complex diagnostic AI/ML devices today.

Summary

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510(k) Summary

TelZuit Cardiac Monitoring System

1. SPONSOR

TelZuit Technologies, Inc. 7044 Stapoint Court Winter Park, FL 32792

Contact Person: Don Sproat, 407-657-0128 Date Prepared: April 17, 2003

2. DEVICE NAME

Proprietary Name: TelZuit Cardiac Monitoring System Common/Usual Name: Ambulatory electrocardiograph recorder and transmitter Telephone electrocardiograph (ECG) transmitter and Classification Name: receiver

3. PREDICATE DEVICES

CardioNet Ambulatory ECG Monitor, CardioNet, Inc. (K003707) .
CardioBeeper® CB-12L, Meridian Medical Technology (K965101) .

4. INTENDED USE

ട. DEVICE DESCRIPTION

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collect and transmit their ECG data to an analysis station for evaluation by a medical professional.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The proposed TelZuit Cardiac Monitoring System and the CardioNet Ambulatory ECG Monitor and CardioBeeper® CB-12L predicate devices are all intended to be used to collect a patient's ECG information and transmit the information via telephone to a remotely located ECG analysis station for evaluation by a medical professional. The design of the proposed and predicate devices allows a patient to collect and transmit their ECG information without direct physician supervision.

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Like the proposed TelZuit Cardiac Monitoring System, the predicate CardioNet Ambulatory ECG Monitor and CardioBeeper® CB-12L include patient-worn electrodes and sensors to record patient ECG information and devices designed to receive ECG information from the sensor and then transfer the information to an ECG analysis station. The major differences include:

Means by which the ECG sensors are positioned (fixed array or individual . placement)
Mode of ECG signal transmission (continuous, event-initiated, or both) .
Length of ECG recording .

The proposed TelZuit Cardiac Monitoring System complies with recognized industry standards for ambulatory ECG electrocardiograph devices. Performance testing demonstrates that ECG tracings can be accurately and reliably reproduced from the signals transmitted by the TelZuit Cardiac Monitoring System. Therefore, the technical differences between the proposed and predicate devices do not raise new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2003 JUL

TelZuit Technologies, Inc. c/o Cynthia J.M. Nolte, Ph.D., RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K031229

Trade Name: TelZuit Cardiac Monitoring System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DXH Dated: April 17, 2003 Received: April 18, 2003

Dear Dr. Nolte:

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 - Cynthia J.M. Nolte, Ph.D., RAC

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.

Bram D. Zuckerman, M.D.

ram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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031229

510(k) Number (if known):

Device Name: TelZuit Cardiac Monitoring System

Indications for Use:

The TelZuit Cardiac Monitoring System consists of a 4-channel ECG (electrocardiograph) monitor (TelZuit Electrode Array Patch) and the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder stores and transmits data received from the TelZuit Electrode Array Patch via cellular telephone to a remotely located ECG analysis station for evaluation by a medical professional.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

April 17, 2003

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).