K Number
K992772
Device Name
CARDIOPHONICS 1000 MEMORY MONITOR
Date Cleared
1999-09-17

(30 days)

Product Code
Regulation Number
870.2920
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cardiophonics memory transmitter is a two-channel cardiac event recorder. It incorporates a microprocessor and analog to digital conversion circuits. This allows the unit to store ECG data in a memory loop configuration. This ECG data is then sent over a analog phone line or RS-232 serial port for display by a PC receiving station. The monitor may be configured and programmed either by the program keys on the monitor or by the PC Cardiophonics 1000 software program. All data is then reviewed by a health professional. This is the same intended use and purpose as previously cleared for the Cardiophonics Memory Transmitter. { 510K K934975 }
Device Description
The Cardiophonics memory transmitter is a two-channel cardiac event recorder. It incorporates a microprocessor and analog to digital conversion circuits. This allows the unit to store ECG data in a memory loop configuration. This ECG data is then sent over a analog phone line or RS-232 serial port for display by a PC receiving station. The monitor may be configured and programmed either by the program keys on the monitor or by the PC Cardiophonics 1000 software program.
More Information

Not Found

No
The description focuses on basic digital signal processing, data storage, and transmission, with no mention of AI/ML algorithms for analysis or interpretation.

No
The device is a cardiac event recorder that stores and transmits ECG data for review by a health professional, but it does not treat or directly intervene in a patient's condition.

Yes
The device is a cardiac event recorder that stores ECG data for review by a health professional, which is used to diagnose cardiac events.

No

The device description explicitly states it incorporates a microprocessor and analog to digital conversion circuits, which are hardware components.

Based on the provided information, 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.
  • Device Function: The Cardiophonics memory transmitter is a cardiac event recorder that collects and transmits ECG data. ECG data is electrical activity from the heart, which is collected externally from the body, not from a sample taken from the body.
  • Intended Use: The intended use is to record and transmit ECG data for review by a health professional. This is a diagnostic tool, but it operates on physiological signals, not on in vitro samples.

Therefore, the device falls under the category of a medical device that records physiological data, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Cardiophonics memory transmitter is a two-channel cardiac event recorder. It incorporates a microprocessor and analog to digital conversion circuits. This allows the unit to store ECG data in a memory loop configuration. This ECG data is then sent over a analog phone line or RS-232 serial port for display by a PC receiving station. The monitor may be configured and programmed either by the program keys on the monitor or by the PC Cardiophonics 1000 software program. All data is then reviewed by a health professional.

Product codes

74DXH

Device Description

Not Found

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

health professional

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K934975

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines suggesting hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 17 1999

Mr. Richard L. Trader President RLT Medical Associates, Inc. 9620 Deereco Road Timonium, MD 21093

K992772 Re: Cardiophonics 1000 Memory Monitor Regulatory Class: II (two) Product Code: 74DXH Dated: August 16, 1999 August 18, 1999 Received:

Dear Mr. Trader:

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 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). 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, qood 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 requlations.

1

Page 2 - Mr. Richard L. Trader

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,
Stuart Holkoy

Thomas J. C Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Intended Use

The Cardiophonics memory transmitter is a two-channel cardiac event recorder. It incorporates a microprocessor and analog to digital conversion circuits. This allows the unit to store ECG data in a memory loop configuration. This ECG data is then sent over a analog phone line or RS-232 serial port for display by a PC receiving station. The monitor may be configured and programmed either by the program keys on the monitor or by the PC Cardiophonics 1000 software program. All data is then reviewed by a health professional.

This is the same intended use and purpose as previously cleared for the Cardiophonics Memory Transmitter. { 510K K934975 }

Nare Rallucy MD. for DBT
(Division Sign-Off)
9-16-99

(Division of Cardiov and Neurological De 510(k) Number