MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR

K973863 · Hi-Tronics Designs, Inc. · DXH · Jan 2, 1998 · Cardiovascular

Device Facts

• Record ID: K973863
• Device Name: MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR
• Applicant: Hi-Tronics Designs, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Jan 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

MEMORYTRACE Model 4224 is a patient-operated ambulatory ECG monitor. Device records ECG signals and transmits data via telephone to a standard ECG receiver for clinical review. Used by patients in home or ambulatory settings to capture symptomatic cardiac events. Healthcare providers use transmitted ECG data to evaluate rhythm/rate disturbances, monitor post-MI recovery, assess anti-arrhythmia therapy, and perform ST segment analysis. Facilitates remote cardiac monitoring, enabling timely clinical decision-making for symptomatic patients.

Clinical Evidence

No clinical data provided; 510(k) clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

Ambulatory ECG monitor; patient-operated; telephone-based data transmission; supports ST segment analysis; intended for infants >10kg to geriatric patients.

Indications for Use

Indicated for patients from infants (>10 kg) through geriatric age requiring ECG documentation of rhythm/rate disturbances, post-MI follow-up, anti-arrhythmia therapy monitoring, or ST segment analysis.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div></div> (Division Sign-Off) |
|---------------|-------------------------------------------------------------------|
| | Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number | K973863 |

| <div> Prescription Use </div> (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|-------------------------------------------------------------|----|----------------------|
|-------------------------------------------------------------|----|----------------------|

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