(56 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on basic ECG signal processing and transmission.
No
The device is used for recording, displaying, and transmitting ECG signals for analysis of cardiac conditions, which are diagnostic purposes, not therapeutic.
Yes
The device is intended for "recording, display, output... for the purpose of cardiac conditions analysis," which indicates it is used to gather information for diagnosis.
Unknown
The provided summary lacks a device description, making it impossible to determine if the device is solely software or includes hardware components. The intended use describes recording and outputting an ECG signal, which typically involves hardware.
Based on the provided information, the CG-5000 ECG MiniMonitor 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 CG-5000 ECG MiniMonitor records, displays, and transmits the electrical activity of the heart (ECG signal). This is a measurement taken directly from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use describes the device's purpose as recording and analyzing the ECG signal for cardiac conditions analysis. This aligns with in-vivo diagnostic procedures, not in-vitro ones.
Therefore, the CG-5000 ECG MiniMonitor is a medical device used for in-vivo diagnosis (diagnosis performed on a living organism), not in-vitro diagnosis.
N/A
Intended Use / Indications for Use
CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.
Product codes (comma separated list FDA assigned to the subject device)
74 DXH
Device Description
Card Guard Model CG-5000 ECG MiniMonitor
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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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.
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).
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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).
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 ОСТ
Mr. Leonid Trachtenberg Chief Engineer Card Guard Scientific Survival Ltd. 2 Pekeris Street, P.O.B. 527 Rehovot 76100 ISRAEL
K992696 Re: ECG Minimonitor, Model CG-5000 Regulatory Class: II (two) Product Code: 74 DXH Dated: August 26, 1999 Received: August 30, 1999
Dear Mr. Trachtenberg:
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, 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 requlations 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.
1
Page 2 - Mr. Leonid Trachtenberg
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,
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
CARD GUARD
Scientific Survival LTD
Page 1 of 1
510(k) Number: K992696
Device Name: Card Guard Model CG-5000 ECG MiniMonitor
Indications For Use:
CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omer L. Goode for DBT
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992696
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)