(153 days)
Not Found
No
The summary describes a standard ECG event recorder with telephonic transmission, and there are no mentions of AI, ML, or related concepts.
No
The device is an ECG event recorder used to detect transient arrhythmias, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "ECG (Electrocardiogram) Event Recorder" used to "record electrical heart signals" to "detect transient arrhythmias." Detecting a medical condition like arrhythmias is a diagnostic function.
No
The device description explicitly states it is a "hand held, 9 Volt battery operated ECG Event Recorder," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- TTM5000 Function: The TTM5000 is an ECG Event Recorder. It records electrical signals from the heart on the patient's body (in vivo). It does not analyze samples taken from the body.
The description clearly states it's a "non-invasive" device that records "electrical heart signals (Electrocardiogram) of the patient." This is a direct measurement of physiological activity within the body, not an analysis of a sample taken from the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DXH
Device Description
TTM5000 Telephonic EKG Monitor is a hand held, 9 Volt battery operated ECG Event Recorder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used mainly by Cardiologists and Internists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
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
3
K973267/A1
Page__________________________________________________________________________________________________________________________________________________________________________ of
K973267 510(k) Number (if known):
TTM5000 TELEPHONIC EKG MONITOR Device Name:
Indications For Use:
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.
(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 __________ | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------- |
| Prescription Use | X (Per 21 CFR 801.109) |
|---|---|
| ------------------ | ------------------------------- |
OR
| Over-The-Counter Use | __________ |
|---|---|
| ---------------------- | ------------ |
(Optional Format 1-2-96)
Sk=54