The CG-6108 system is an Arrhythmia ECG Event Recorder designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chestworn 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 preand 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 and arrhythmias 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.

AI/ML Overview

The provided document is a 510(k) summary for the CG-6108 Arrhythmia ECG Event Recorder. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but does not contain a study or data proving that the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for arrhythmia detection).

The document mentions that the PMP4 Medical Application, which is part of the CG-6108 system, "incorporates an algorithm specially developed for detection of arrhythmia artifacts, e.g., AF" and that "A detected artifact triggers transmission of the signal to the CG Monitoring Center for analysis." However, it does not provide any performance metrics for this algorithm.

Instead, the document focuses on demonstrating compliance with various general and medical device-specific standards (e.g., MDD 93/42/EEC, EN 60601-1 for safety and EMC).

Therefore, based on the information provided, it is not possible to fill out the requested information regarding acceptance criteria and a study proving device performance in terms of diagnostic accuracy or clinical effectiveness.

Here's what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Diagnostic Performance)	Reported Device Performance
Not specified in the document.	Not specified in the document. The document states the device "incorporates an algorithm specially developed for detection of arrhythmia artifacts, e.g., AF," but no performance data (sensitivity, specificity, etc.) is provided.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document indicates that detected events are transmitted to a "CG Monitoring Center for professional analysis," suggesting human interpretation, but details about the experts or ground truth establishment are absent for any test set.

4. Adjudication method for the test set

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not specified. There is no mention of an MRMC study or an assessment of human reader improvement with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not explicitly stated, but the document mentions an "algorithm specially developed for detection of arrhythmia artifacts." However, no performance metrics for this standalone algorithm are provided. The system is designed for "analysis by medical professionals at a remote Monitoring Center" after an event is detected by the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified.

8. The sample size for the training set

Not specified.

9. How the ground truth for the training set was established

Not specified.

Summary of what's provided for safety and regulatory compliance, not diagnostic performance:

The document primarily focuses on demonstrating:

Intended Use: For patients experiencing transient symptoms suggesting cardiac arrhythmia.
Classification: Class II device, product code DXH (Telephone Electrocardiograph Transmitters and Receivers).
Substantial Equivalence: Claimed to predicate devices from Card Guard for memory loop monitoring, arrhythmia artifact detection algorithm (CG-6550 K003220 for AF detection algorithm), and Bluetooth transmission/software (PMP4 SelfCheck ECG K042254).
Compliance with Standards: Meeting various international and European standards for medical devices, electrical safety, quality management, and risk management (e.g., MDD 93/42/EEC, EN 60601-1, EN ISO 13485, EN ISO 14971). These standards relate to device safety and manufacturing, not diagnostic accuracy of the arrhythmia detection algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Card Guard Scientific Survival LTD. The words "CARD GUARD" are in bold, and the words "Scientific Survival LTD" are in a smaller font size below the words "CARD GUARD". To the right of the words is a line graph that resembles an EKG.

CG-6108 Arrhythmia ECG Event Recorder 510(k) Summary of Safety and Effectiveness

1. General K060911 pg1/2
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 Arrhythmia ECG Event Recorder
Classification:	Transmitters and receivers, electrocardiograph, telephone
Product Code:	DXH
Regulation No:	21 CFR 870.2920
Class:	II

Definition and Intended Use 2.

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 preand 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 and arrhythmias 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.

PMP4 Medical Application 3.

The PMP4 Medical 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 (and other Card Guard's devices), the test results and other medical data, to process and save these test results, and synchronize data and test results with the PMP4 Medical Center. The Application is a part of a personal medical system solution. The PMP4 Medical Application performs the following activities:

Receives medical test inputs from the external accessories 1.
Collects medical test data and other related information as defined for each test 2.
Accesses historical test and related data stored on the device 3.
Transmits medical test data and additional information to Center for professional evaluation/backup 4.
న. Receives data from Center
Enables configuring GPRS data connection (based on mobile phone GPRS/CDMA 6. capabilities), changing user name and password.

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4. 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. The CG-6108 meets the requirements of the following standards:

(1) MDD 93/42/EEC Medical Device Directive Council Directive 93/42/EEC; June 14, 1993
EN 475: Medical devices Electrically-generated alarm signals ; April 1995 (2)
EN 980: Graphical symbols for use in the labeling of medical devices; August 2003 (3)
(4) EN 1041: Terminology, Symbols and Information provided with Medical Devices; Information supplied by the manufacturer with medical devices; April 1998
EN ISO 9001 : Quality management systems Requirements; December 2000 (ર)
EN ISO 13485: Quality systems Medical devices; August 2000 (6)
EN ISO 14971: Medical devices application of risk management to medical devices; March 2001 (7)
EN ISO 10993 Biological evaluation of medical devices Part 1: Evaluation and testing; Dec. 1997 (8)
EN 60601-1: Medical electrical equipment; Part 1: General requirements for safety; Sept. 2002 (9)
(10) EN 60601-1-2: Medical electrical equipment; Part 1: 2. Collateral Std: EMC; requirements and tests; 2001
(11) EN 60601-1-4: Medical electrical equipment; Part 1: 4. Collateral Std: Programmable electric medical systems; Apr. 01

5. Indications for use

The CG-6108 Arrhythmia ECG Event Recorder is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia.

6. Principles of operation

The CG-6108 Arrhythmia ECG Event Recorder comprises a chest-worn ECG sensor with three electrodes and a handheld device with a proprietary PMP4 Medical Application, used to process and transmit the ECG recordings. The battery powered chest-worn unit has an ASIC and a fransceiver for the acquisition, recording, and transmission of the ECG signals are transmitted via Bluetooth to the handheld device equipped with the PMP4 Medical Application, which incorporates an algorithm specially developed for detection of arrhythmia artifacts, e.o., &F. A detected artifact triggers transmission of the signal to the CG Monitoring Center for analysis.

7. Substantial Equivalence

The clearance for the CG-6108 is sought on the grounds of its claimed substantial equivalence (SE) to the following predicate devices:

Card Guard's CG-6106 K963811 for its memory loop monitoring principle of operation and 1. the identity of the intended use.
Card Guard's CG-6550 K003220 Personal 3-lead ECG Transmitter for its arrhythmia artifacts 2. detection algorithm (e.g. AF)
Card Guard's PMP4 SelfCheck ECG K042254 for the BT transmission capability and for 3. interfacing and including the PMP4 Medical Application - the CG proprietary SW for storing, measuring, displaying and transmitting data gathered from medical sensors.

8. Conclusions

The CG-6108 Arrhythmia ECG Event Recorder constitutes a safe and reliable means for designed for self-testing by patients who experience transient symptoms that may suggest cardiac arrhythmia. Its material composition and operation present no adverse health effect or safety risks 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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Image /page/2/Picture/2 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

JUN 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Manager, Regulatory Affairs 2 Pekeris St. P.O. Box 527 Rehovot 76101 ISRAEL

Re: K060911

Trade Name: CG-6108 Arrhythmia ECG Event Recorder Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DXH Dated: August 4, 2006 Received: August 4, 2006

Dear Mr. Gonorovsky:

This letter corrects our substantially equivalent letter of August 22, 2006 and the subsequent correction letter of March 27, 2007.

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

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Page 2 - Mr. Alex Gonorovsky

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.

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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Bimmerman for

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

ﻨﻴﻮ 510(k) Number (if known): Кобо9 II

Device Name: CG-6108 Arrhythmia ECG Event Recorder

Indications for Use:

Intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia

Prescription Use 区 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.himma

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K /1/20911

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(Posted November 13, 2003)

Regulation Number and Section

§ 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).