(196 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No
The device is described as a transmitter for monitoring and detection, not for treating or providing therapy.
Yes
The device is intended for "detection of rhythm disorders and ST-changes," which are specific medical conditions, indicating a diagnostic purpose.
No
The device description explicitly states "Card Guard Model CG-6550 Personal 3-Lead ECG Transmitter," which implies a hardware component (a transmitter) is part of the 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.
- Device Function: The CG-6550 is an Electrocardiogram (ECG) Transmitter. It measures electrical activity of the heart from the body's surface. This is an in vivo measurement (taken from within the living body), not an in vitro measurement (taken from a sample outside the body).
- Intended Use: The intended use is for "long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes." This is a diagnostic function, but it's based on the direct measurement of the heart's electrical activity, not on analyzing a sample.
Therefore, based on the provided information, the CG-6550 is a medical device used for in vivo diagnostic monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CG-6550 is a Personal 3-Lead Electrocardiogram (ECG) Transmitter intended for long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes.
Product codes
74 DXH
Device Description
Card Guard Model CG-6550 Personal 3-Lead ECG Transmitter
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
Not Found
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)
Not Found
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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with intertwined snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1999
Mr. Leonid Trachtenberg Card Guard Scientific Survival Ltd. 2 Pekeris Street, P.O.B. 527 Rehovot 76100 ISRAEL
Re: K990478 Card Guard Personal ECG Transmitter Model CG-6550 Regulatory Class: II (two) Product Code: 74 DXH Dated: June 6, 1999 Received: June 8, 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 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 requlation (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 requlatory 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"(21 CFR 807.97). Other qeneral 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. Callahan, Ph.D.
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 :
Device Name: Card Guard Model CG-6550 Personal 3-Lead ECG Transmitter.
Indication For Use:
The CG-6550 is a Personal 3-Lead Electrocardiogram (ECG) Transmitter intended for long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Den Th. Miller
(Division Sign-Off) Division of Cardiovascular, Respirato and Neurological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
ﺎﻧﻌ
OR
Over-The-Counter Use
(Optional Format 1-2-96)