TTM5000 TELEPHONIC EKG MONITOR by HDS MEDICAL, INC.

TTM5000 is a fully featured, non-invasive 9 Volt battery operated ECG (Electrocardiogram) Event Recorder. The intended use of TTM5000 is to record electrical heart signals (Electrocardiogram) of the patient. The recorded analog data can be transmitted over the telephone lines to a transtelephonic ECG receiving system. it is used mainly by Cardiologists and Internists to detect transient arrhythmias. The device is also called arrhythmia recorder.

Device Description

TTM5000 Telephonic EKG Monitor is a hand held, 9 Volt battery operated ECG Event Recorder.

AI/ML Overview

This document (K973267) is a 510(k) summary for the TTM5000 Telephonic EKG Monitor, which aims to demonstrate substantial equivalence to a predicate device (Heartrak, K960499). It does not contain a detailed study report with specific acceptance criteria and performance metrics for the TTM5000 device itself.

Based on the provided text, I can infer the following:

Acceptance Criteria: Not explicitly stated as specific numerical thresholds (e.g., sensitivity, specificity). The acceptance here is based on substantial equivalence to the predicate device, implying that the TTM5000 must perform similarly to the Heartrak. The document highlights shared characteristics as the basis for this substantial equivalence.
Device Performance: The document states that the TTM5000 records 40 seconds of Electrical Heart Signals (Electrocardiogram) and transmits the audible analog signal through telephone lines, with output at the transtelephonic ECG recording system being a conventional ECG display. This mirrors the stated capabilities of the predicate device.

Here's a breakdown of the requested information, with explicit notes about what is NOT available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred from Substantial Equivalence to Predicate)	Reported TTM5000 Device Performance (from K973267)
Non-invasive operation	Non-invasive
9-volt battery operated	9-volt battery operated
Records 40 seconds of Electrical Heart Signals (ECG)	Records 40 seconds of Electrical Heart Signals (ECG)
Transmits audible analog signal via telephone lines	Transmits the audible analog signal through telephone lines
Output is a conventional ECG display at receiving system	Output at the transtelephonic ECG recording system is a conventional ECG display
Claims/Offered as laboratory analysis equipment	Claims/Offered as laboratory analysis equipment
Remote convenience and easy response	For remote convenience and easy response
(Implicit) Safety and Efficacy comparable to predicate	"This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy." (Specific metrics for this claim are not provided in the document.)

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

Sample Size for Test Set: Not provided. The document does not describe a clinical study or a test set used to independently evaluate the TTM5000's performance against specific metrics. The substantial equivalence argument relies on shared characteristics and intended use with a predicate device.
Data Provenance: Not provided. Since no specific test set is described, there's no information on country of origin or whether data was retrospective or prospective.

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

Not applicable. As no specific test set or clinical study is described for the TTM5000 in this document, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not applicable. No test set is described.

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

No. This document describes a telephonic EKG monitor, which is a device for recording and transmitting ECG signals, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant to this submission and was not conducted.

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

Not explicitly described. The document focuses on the device's functional equivalence to the predicate. While the device itself performs the recording and transmission automatically (standalone operation for its primary functions), there is no separate "algorithm only" performance evaluation described in the sense of a diagnostic algorithm's accuracy that would typically be evaluated standalone. The output is a "conventional ECG display," which still requires human interpretation.

7. The type of ground truth used

Not applicable for TTM5000 performance. Since no specific study evaluating the TTM5000's diagnostic accuracy is detailed, there's no mention of ground truth (e.g., pathology, outcomes data). The "ground truth" for the 510(k) submission is that the predicate device (Heartrak) is already legally marketed and presumed safe and effective for its intended use.

8. The sample size for the training set

Not applicable. The TTM5000 is described as an ECG event recorder and transmitter, not a device that utilizes machine learning or AI requiring a training set.

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

Not applicable. See point 8.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence based on the functional and technical similarities between the TTM5000 and a predicate device. It does not contain a detailed report of a clinical study or performance testing with specific acceptance criteria, sample sizes, or ground truth establishment for the TTM5000's diagnostic capabilities. The claims of safety and efficacy are general and rely on the substantial equivalence to the already marketed predicate device, as well as adherence to Good Manufacturing Procedures.

Summary

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JAN 2 9 1998

KG73267

Section 2 - Summary of Safety and Effectiveness for TTM5000 - Telephonic EKG Monitor

TTM5000 Telephonic EKG Monitor is a hand held, 9 Volt battery operated ECG Event Recorder. HDS Medical Inc. has determined that TTM5000 is substantially equivalent to a predicate medical device which is currently in commerce and has been submitted to the FDA via K960499 as an Transtelephonic ECG Event Recorder and is identified as Heartrak, marketed by Universal Medical Inc.

A determination of substantial equivalance is based upon:

Both Heartrak and TTM5000 are non-invasive, 9 Volt battery operated, records 40 seconds of Electrical Heart Signals (Electrocardiogram) and transmit the audible analog signal through telephone lines. Both devices output at the transtelephonic ECG recording system are conventional ECG display.

Both device have claims or, are offered as, laboratory analysis equipment. Both are for remote convenience and easy response.

TTM5000 has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate in ease of use.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. HDS Medical Inc. continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information.

CERTIFICATION:

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

Olmütz, lüt

Semih Cirit President HDS Medical inc. 2 Faire Winds Laguna Niguel, CA 92677 Tel: 714-248-8587

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract design of an eagle's head composed of three curved lines, symbolizing health and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 1998

Mr. Semih Cirit HDS Medical Inc. 2 Faire Winds Laguna Niguel, CA 92677

Re: K973267 TTM5000 Telephonic EKG Monitor Regulatory Class: II (two) Product Code: 74 DXH Dated: November 25, 1997 Received: November 26, 1997

Dear Mr. Cirit:

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 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 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 (Premarket Approval), 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 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. Semih Cirit

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 (301) 594-4648. 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" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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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K973267/A1

Page__________________________________________________________________________________________________________________________________________________________________________ of

K973267 510(k) Number (if known):

TTM5000 TELEPHONIC EKG MONITOR Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number __________
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Prescription Use	X (Per 21 CFR 801.109)
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Over-The-Counter Use	__________
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(Optional Format 1-2-96)

Sk=54

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).