(85 days)
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No
The summary describes a device for recording and transmitting ECG data, but there is no mention of AI, ML, or any related technologies for analysis or interpretation.
No
The device is a monitor that records and transmits ECG data for diagnostic purposes, not for active treatment.
Yes
The device records and transmits ECG data to aid in evaluating symptomatic episodes, post-myocardial infarction follow-ups, anti-arrhythmia therapy, and cases requiring ST segment analysis, which are all diagnostic purposes.
No
The device description explicitly states it is a "patient-operated device designed to record and transmit a patient's ECG," implying the existence of hardware to perform these functions. It is not described as purely software running on existing hardware.
Based on the provided information, the MEMORYTRACE™ Model 4224 monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The MEMORYTRACE™ Model 4224 monitor records and transmits a patient's ECG. This is a measurement of electrical activity within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes the device as an aid in evaluating symptomatic episodes of rate disturbances, post-myocardial infarction follow-ups, anti-arrhythmia therapy, and cases requiring ST segment analysis. These are all related to monitoring and analyzing the electrical activity of the heart in vivo.
Therefore, the device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The MEMORYTRACE™ Model 4224 monitor is a patient-operated device designed to record and transmit a patient's ECG for the documentation of thythm and/or rate disturbances. The recorded ECG data can be transmitted over a telephone to a standard ECG receiver. The ECG transmissions are intended as aids in evaluating symptomatic episodes of rate disturbances, postmyocardial infarction follow-ups, anti-arrhythmia therapy, and cases that require ST segment analysis.
Product codes
74 DXH
Device Description
The MEMORYTRACE™ Model 4224 monitor is a patient-operated device designed to record and transmit a patient's ECG.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
from infants whose weight is greater than 10 kg (22 lbs) through geriatric patients with no upper limit.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is composed of three curved lines that suggest the shape of the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
JAN - 2 1998
Mr. Jacques P. Schwartz Vice President Hi-tronics Designs, Inc. 58 Route 46 West Budd Lake, NJ 07828
K973863 Re: MEMORYTRACE™ Model 4224 Ambulatory ECG Trade Name: Requlatory Class: II (two) Product Code: 74 DXH Dated: October 7, 1997 Received: October 9, 1997
Dear Mr. Schwartz:
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 General with the Good Manufacturing Practice for Medical Devices: (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements requlatory action. 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. Jacques P. Schwartz
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 requlation (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callaha Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K973863
MEMORYTRACE™ Model 4224 Product Name:
The MEMORYTRACE™ Model 4224 monitor is a patient-Indications for use: operated device designed to record and transmit a patient's ECG for the documentation of thythm and/or rate disturbances. The recorded ECG data can be transmitted over a telephone to a standard ECG receiver. The ECG transmissions are intended as aids in evaluating symptomatic episodes of rate disturbances, postmyocardial infarction follow-ups, anti-arrhythmia therapy, and cases that require ST segment analysis. The intended population is from infants whose weight is greater than 10 kg (22 lbs) through geriatric patients with no upper limit.
(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 | K973863 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)