(115 days)
No
The summary describes a standard ECG recorder and transmitter with firmware tools, but there is no mention of AI, ML, or any related concepts like image processing, DNN, or training/test sets for algorithms.
No
The device is described as an electrocardiograph for cardiac monitoring and diagnosis, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "for the purpose of cardiac monitoring and diagnosis," indicating its use in identifying medical conditions. The "Device Description" also reiterates "for the purpose of cardiac monitoring and diagnosis."
No
The device description explicitly states it incorporates "recording/transmitting circuitry" and a "graphic LCD," which are hardware components. While it includes "firmware tools," it is not solely software.
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. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that this device is a 12-Lead electrocardiograph. It records and transmits electrical activity of the heart from the body.
- Intended Use: The intended use is for cardiac monitoring and diagnosis by recording ECGs, which is a physiological measurement taken directly from the patient.
The device deals with electrical signals from the body, not with analyzing samples taken from the body. Therefore, it falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CG-7000DX-BT ECG Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard FCGs for the purpose of cardize monitoring and diagnosis. The device incorporates a recording and transmitting circuitry. graphic LCD, a package of firmware tools. The BT module (Tiden-Yuden Ltd.) conveys data to a remote hand held receiving device/PC or laser/Ink-jet printer.
The CG-7000DX-BT is intended for use by a medical professional:
- a. The ECG is recorded and transmitted to a remote receiving station for consultation with a cardiologist.
- b. The ECG is recorded and transferred to a remote hand held device/PC/printer for viewing and processing.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The CG-7000DX-BT ECG Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard FCGs for the purpose of cardize monitoring and diagnosis. The device incorporates a recording and transmitting circuitry. graphic LCD, a package of firmware tools. The BT module (Tiden-Yuden Ltd.) conveys data to a remote hand held receiving device/PC or laser/Ink-jet printer.
Features and Functions:
-
- Graphic display for ECG representation and device control
-
- One screen shows 1,52 sec lead length. For viewing full leads scrolling is used
-
- Device features a keypad with 17 keys for device control and data input
-
- Device is energized by pressing power on/off key
-
- Device records 12-leads ECG simultaneously and stores up to 40 ECG
-
- Lead duration is menu selectable: 4, 8, 12, 16, and 20 seconds
-
- All records include a mandatory minimum 12 seconds arrhythmia trace
-
- Recorded ECG and data are transmitted via BT class II module (Tiden-Yuden Ltd.) to a remote hand held receiving device/PC or laser/Ink-jet printer.
-
- Low battery detection
-
- BIT mode is provided for the device self-test
-
- Accurate pacemaker artifact detection and marking
-
- Patient Cable with a cable-connector, a molded fanout shell and 10 lead wires
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
medical 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): 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.
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.
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).
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/2 description: The image shows the words "CARD GUARD" in bold, black letters. There is a line underneath the words. The image is a close-up of the words, and the background is white.
CG-7000DX-BT ECG Recorder/Transmitter 510(k) Summary of Safety and Effectiveness
1. Definition and Intended Use
The CG-7000DX-BT ECG Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard FCGs for the purpose of cardize monitoring and diagnosis. The device incorporates a recording and transmitting circuitry. graphic LCD, a package of firmware tools. The BT module (Tiden-Yuden Ltd.) conveys data to a remote hand held receiving device/PC or laser/Ink-jet printer.
The CG-7000DX-BT is intended for use by a medical professional:
- a. The ECG is recorded and transmitted to a remote receiving station for consultation with a cardiologist.
- b. The ECG is recorded and transferred to a remote hand held device/PC/printer for viewing and processing.
CG-7000DX-BT is classified as Class II medical device.
2. Referenced Standards
No performance standards have been developed under Section 514 of the Federal Food. Drug and Cosmetic Art for telephone ECG transmitter devices. The CG-7000DX-BT Recorder/Transmitter meets the requirements of the following standards:
- (1) ANSI/AAMI EC38. "Ambulatory Electrocardiographs" 1994
- (2) ANSI/AAMI EC13 Cardiac Monitors, Heart Rate Metersand Alarms, 2nd edition 1992
- (3) ANSI/AAMI EC11 Diagnostic Electrocardiographic Devices, 2nd edition 1991
- (4) IEC 601-1- 4: 1996 Medical Electrical Equipment (safety).
3. Features and Functions
-
- Graphic display for ECG representation and device control
-
- One screen shows 1,52 sec lead length. For viewing full leads scrolling is used
-
- Device features a keypad with 17 keys for device control and data input
-
- Device is energized by pressing power on/off key
-
- Device records 12-leads ECG simultaneously and stores up to 40 ECG
-
- Lead duration is menu selectable: 4, 8, 12, 16, and 20 seconds
-
- All records include a mandatory minimum 12 seconds arrhythmia trace
-
- Recorded ECG and data are transmitted via BT class II module (Tiden-Yuden Ltd.) to a remote hand held receiving device/PC or laser/Ink-jet printer.
-
- Low battery detection
-
- BIT mode is provided for the device self-test
-
- Accurate pacemaker artifact detection and marking
-
- Patient Cable with a cable-connector, a molded fanout shell and 10 lead wires
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CG-7000DX-BT ECG Recorder/Transmitter 510(k) Summary of Safety and Effectiveness
4. Substantial Equivalence
CG-7000DX-BT is substantially equivalent to Card Guard CG-7000DX, legally marketed under 510(k) premarket clearance K993799 and resembles PMP4 SelfCheck™ ECG K042254 in the use of the Bluetooth method and protocol.
CG-7000DX-BT and CG-7000DX have the same main principles of operation and technical specifications. The differences between the devices are intended to improve the effectiveness for its intended use, and are shown to have no adverse effect on safety and efficacy.
CG-7000DX-BT and CG-7000DX. have the following characteristics in common:
- . Similar intended use, and
- Similar principles of operation, features and technological characteristics. .
5. Material differences
The most important innovation in CG-7000DX-BT is its new capability to transmit data via Bluetooth (instead of the Universal IR/Acoustic Adapter) to a remote hand held receiving device and printer (in addition to the receiving station, and a local PC).
Bluetooth is an open standard for short-range transmission of data that supports point-topoint and multipoint applications.
6. Conclusions
CG-7000DX-BT ECG Recorder/Transmitter, constitutes a safe and reliable means for recording and transmitting standard ECG for the purpose of cardiac condition monitoring and diagnosis. Its material composition and of operation present no adverse health effect or safety risks to patients when used as intended.
The device is as safe. as effective and performs as well as or better than its cleared predicate device.
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| I LEE MILLE BEAULT FOR COLLECT OF THE FORMIC FOR FORMER FOR FORMIC FOR FORMIC FOR FORMIC FOR FORMIC FOR FORMIC FOR FORMIC FOR FORMIC FOR FORMIC FOR FORMIC FOR FORMIC FOR FORM | 505300
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2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 9 2006
Card Guard Scientific Survival, Ltd. c/o Mr. Alex Gonorovsky Manager. Regulatory Affairs 2 Pekeris St. Rehovot ISRAEL
Re: K052556
Trade Name: CG-7000DX-BT ECG Recorder/Transmitter Regulation Number: 21 CFR 870.2920 Regulation Name: Transmitters and receivers, Electrocardiograph, Telephone Regulatory Class: Class II (two) Product Code: DXH Dated: December 19, 2005 Received: December 23, 2005
Dear Mr. Gonorovsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Alex Gonorovsky
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc acrised a determination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I odetar states and the ext s requirements, including, but not limited to: registration and listing (21 comply with an all alle 110 - 21 CFR Part 801); good manufacturing practice requirements as set OF It in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. production of the manufally marketing your device as described in your Section 510(k) I mis lotter will and w you to organization of substantial equivalence of your device to a legally prematics noticated. The start 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhummoe for
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052556
Device Name: CG-7000DX-BT ECG Recorder/Transmitter
Indications for Use:
12-Lead electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, incorporates recording/ transmitting circuitry, graphic LCD, a package of firmware tools and is intended for use by a medical professional:
- a. The ECG is recorded and transmitted to a remote receiving station for consultation with a cardiologist.
- b. The ECG is recorded and transferred to a remote hand held device/PC/printer for viewing and processing.
Prescription Use 1× (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Brumpton
Aslon Sign-Off Islon of Cardlovascular Devices O(k) Number kosds 30
Page 1 of 1
(Posted November 13, 2003)
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