(151 days)
Not Found
No
The description mentions an "arrhythmia detection algorithm" and "programmable thresholds," but does not provide any details suggesting the use of AI or ML for this detection. The focus is on signal processing and transmission.
No
The device continuously monitors ECG, detects arrhythmias, and transmits data for evaluation, but it does not treat or directly alleviate a medical condition.
Yes
The device continuously monitors ECG, automatically triggers alarms based on an arrhythmia detection algorithm, and transmits recorded data for medical practitioner evaluation, which are all diagnostic functions.
No
The device description explicitly states it comprises a chest-worn ECG sensor with electrodes, a battery, an ASIC, and a Bluetooth transceiver, in addition to the handheld device with software. This indicates significant hardware components beyond just 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.
- Device function: The CG-6108 Continuous ECG Monitor and Arrhythmia Detector works by monitoring electrical signals from the heart (ECG) through electrodes placed on the chest. It analyzes these signals to detect arrhythmias and transmits the data.
- No sample analysis: The device does not analyze any biological samples taken from the patient's body. It directly measures a physiological signal.
Therefore, the device falls under the category of a medical device that monitors physiological parameters, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors a one lead ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
Product codes
DSI, DXH
Device Description
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector system is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings.
The chest-worn unit includes 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal.
The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to record the signal received from the sensor and to allow pre- and post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable thresholds that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled remotely to provide the physician with more information, when requested by the CG Monitoring Center.
The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest (for ECG sensor)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Patients (self-testing at home), Medical professionals (at a remote Monitoring Center)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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| | CG-6108 Continuous ECG Monitor and Arrhythmia Detector
510(k) Summary of Safety and Effectiveness | |
|-----------------|------------------------------------------------------------------------------------------------------|--------------------|
| Submitter | Card Guard Scientific Survival Ltd., | |
| Address | 2 Pekeris St. P.O.B. 527 Rehovot 76100, Israel | |
| Contact: | Alex Gonorovsky, RA Manager | |
| Phone: | 972-8-9484019 | Fax: 972-8-9484044 |
| E-mail: | galex@cardguard.com | |
| Device | | |
| Trade Name: | CG-6108 Continuous ECG Monitor and Arrhythmia Detector | |
| Classification: | detector and alarm, arrhythmia | |
| Product Code: | DSI | |
| Regulation No: | 870.1025 | |
| Class: | II | |
1. Definition
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector system is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings.
The chest-worn unit includes 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal.
The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to record the signal received from the sensor and to allow pre- and post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable thresholds that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled remotely to provide the physician with more information, when requested by the CG Monitoring Center.
The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.
2. Medical Application
The Application is designed for wireless mobile platforms, e.g. PDA, SmartPhone and for static platforms, i.e., PC. It is used to receive from the CG-6108, the test results and other medical data, to process and save these test results, and synchronize data and test results with the Medical Center. The Application is a part of a personal medical system solution. The Medical Application performs the following activities:
-
- Receives medical test inputs from the external accessories
-
- Collects medical test data and other related information as defined for each test
- Accesses historical test and related data stored on the device 3.
-
- Transmits medical test data and additional information to Center for professional evaluation/backup
- న్. Receives data from Center
- Enables configuring GPRS data connection (based on mobile phone GPRS/CDMA capabilities), 6. changing user name and password.
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Image /page/1/Picture/0 description: The image shows the words "CARD GUARD" in bold, black letters. Below the words is the phrase "Scientific Survival LTD" in a smaller, lighter font. The text is aligned to the left side of the image.
3. Referenced Standards
No performance standards have been developed under Section 514 of the Federal Food, Drug and Cosmetic Art for wireless ECG event recording devices. Following are reference standards:
- Arthythmia Detector and Alarm Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: (1) October 28, 2003
- ANSVAAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement (2) Algorithms
- (3) ANSI/AAMI EC38:1998 Ambulatory Electrocardiograph
- IEC 60601-2-27 2005 Medical electrical equipment Part 2: Particular requirements for the safety of (4) electrocardiographic monitoring equipment
- EN 475: Medical devices Electrically-generated alarm signals ; April 1995 (5)
- EN 980: Graphical symbols for use in the labeling of medical devices; August 2003 (6)
- EN 1041: Terminology, Symbols and Information provided with Medical Devices; Information supplied by the (7) manufacturer with medical devices; April 1998
- EN ISO 9001: Ouality management systems Requirements: December 2000 (8)
- EN ISO 13485: Quality systems Medical devices; August 2000 (9)
- (10) EN ISO 14971: Medical devices application of risk management to medical devices; March 2001
- (11) EN ISO 10993 Biological evaluation of medical devices Part 1: Evaluation and testing: Dec. 1997
- (12) EN 60601-1: Medical electrical equipment; Part 1: General requirements for safety; Sept. 2002
- (13) EN 60601-1-2: Medical electrical equipment; Part 1: 2. Collateral Std: EMC; requirements and tests; 2001
- (14) EN 60601-1-4: Medical electrical equipment; Part 1: 4. Collateral Std: Programmable electric medical systems; 2001
4. Indications For Use
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors a one lead ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
5. Principles of operation
The CG-6108 system comprises a chest-worn ECG sensor with 3 electrodes and a handheld device with a Medical Application, used to process and transmit the ECG recordings. The battery powered chest-worn unit has an ASIC and a transceiver for acquisition, recording, and transmission of the ECG signal. The ECG signals are transmitted via Bluetooth to the handheld device equipped with the Medical Application, which incorporates an algorithm for AF detection. A detected event triggers transmission of the signal to the CG Monitoring Center for analysis.
6. Substantial Equivalence
The clearance for the CG-6108 is sought on the grounds of its claimed substantial equivalence (SE) to the following predicate devices:
- Cardiac Telecom Corp's Heartlink, Model II K982803 for Product Code DSI (Reg. Number 2. 870.1025).
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Image /page/2/Picture/0 description: The image contains the words "CARD GUARD" in bold, black font. Below that, in a smaller font, are the words "Scientific Survival LTD". To the right of the words is a graphic that resembles a heart rate monitor. The graphic is black and consists of a line that goes up and down in a jagged pattern.
CG-6108 Continuous ECG Monitor and Arrhythmia Detector 510(k) Summary of Safety and Effectiveness
7. Conclusions
The CG-6108 device constitutes a safe and reliable means for self-testing by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device is at least as safe, effective, and reliable as the cleared predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2007
Card Guard Scientific Survival, Inc. c/o Mr. Gregory Levine Arnold & Porter, LLP 555 12 St NW Washington DC 20004
Re: K071995
Trade/Device Name: Card Guard CG-6108 Continuous ECG Monitor and Arrhythmia Detector Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: II (special controls) Product Code: DSI, DXH Dated: October 26, 2007 Received: October 26, 2007
Dear Mr. Levine:
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.
4
Page 2 - Mr. Gregory Levine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimlima fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko71995
Device Name: CG-6108 Continuous ECG Monitor and Arrhythmia Detector
Indications for Use:
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arthythmia. The device continuously monitors a one lead ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
Prescription Use >> (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. hummer
(Division/Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071995
Page 1 of 1
(Posted November 13, 2003)