CG-7000DX Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, which incorporates a recording and 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 PC for viewing and processing.

Device Description

AI/ML Overview

The provided text describes the CG-7000DX Recorder/Transmitter, a 12-lead ambulatory electrocardiograph. However, the document is a 510(k) Summary of Safety and Effectiveness for a medical device and does not contain a study that proves the device meets specific acceptance criteria in the typical format of a clinical or performance study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (CG-7000D) and lists various verification, validation, and environmental tests conducted as part of design controls. These tests ensure the device's compliance with design specifications and relevant standards, but they are not presented as a study with reported performance against quantitative acceptance criteria in the way a clinical trial or performance study would be.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred and indicate where information is not present.

Description of Acceptance Criteria and Device Performance

The CG-7000DX Recorder/Transmitter is indicated for recording and transmitting up to 40 standard 12-lead ECGs for cardiac monitoring and diagnosis. The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to its predicate device, the CG-7000D ECG Recorder/Transmitter (K942704). The document attests that the CG-7000DX is as safe, effective, and performs as well as or better than the predicate device.

The acceptance criteria are implicitly defined by compliance with the following standards and successful completion of the listed verification, validation, and environmental tests:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Standards & Tests)	Reported Device Performance (as stated in the document)
Standards Compliance:
ANSI/AAMI EC38, "Ambulatory Electrocardiographs" 1994	Met
ANSI/AAMI EC13 Cardiac Monitors, Heart Rate Meters and Alarms, 200 edition 1992	Met
ANSI/AAMI EC11 Diagnostic Electrocardiographic Devices, 2nd edition 1991	Met
IEC-601-1-4 Medical Electrical Equipment 1996	Met
Design Control Tests:
SW Unit/Module Testing (19 tests)	Conducted, device compliant with design specifications
User Interface Verification Test	Conducted, device compliant with design specifications
Reference Voltage Verification Test	Conducted, device compliant with design specifications
Clock Oscillator Verification Test	Conducted, device compliant with design specifications
Flash Memory Verification Test	Conducted, device compliant with design specifications
LPF Verification Test	Conducted, device compliant with design specifications
QRS Detection Test	Conducted, device compliant with design specifications
PM Pulse Detection Test	Conducted, device compliant with design specifications
Patient Cable Test	Conducted, device compliant with design specifications
Common Mode Rejection Test	Conducted, device compliant with design specifications
Frequency Response Test	Conducted, device compliant with design specifications
Input Dynamic Range Test	Conducted, device compliant with design specifications
Overall System Error Test	Conducted, device compliant with design specifications
Step Response Test	Conducted, device compliant with design specifications
System Noise Test	Conducted, device compliant with design specifications
Safe Current Test	Conducted, device compliant with design specifications
High and Low Temperature and Humidity Test	Conducted, device compliant with design specifications
Surface Temperature Test	Conducted, device compliant with design specifications
Leakage Current Test	Conducted, device compliant with design specifications
Dielectric Strength Test	Conducted, device compliant with design specifications
Mechanical Vibration Shock Test	Conducted, device compliant with design specifications
Ingress of Liquids Test	Conducted, device compliant with design specifications
EMC Test	Conducted, device compliant with design specifications
Biocompatibility Evaluation	Satisfactory
System Safety and Risk Analysis	Conducted, rigorous design and structural evaluation
Level of Concern	Characterized as a moderate level of concern system
Clinical Performance:	"As safe, as effective and performs as well as or better than the legally marketed predicate device, CG-7000D ECG Recorder/Transmitter (K942704)."

Study Details:

Sample size used for the test set and the data provenance:
- The document mentions "laboratory testing" and "clinical and laboratory testing" but does not specify sample sizes for any test sets related to performance evaluation (e.g., number of ECGs, number of patients, etc.).
- The provenance of any data (e.g., country of origin, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The document describes engineering/design control tests and claims substantial equivalence, but it does not detail a study involving expert-established ground truth for diagnostic performance. The intended use includes "consultation with a cardiologist" but this refers to the use of the device, not the validation of its performance in a clinical study as described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. As detailed above, there is no described study requiring an adjudication method.
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:
- No such study was done or reported. The device is an ECG recorder/transmitter, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of diagnostic AI. The device itself has internal algorithms (e.g., QRS detection, PM Pulse Detection), which were tested as part of the "SW Unit/Module Testing" and other verification tests. However, these are part of the device's basic functionality, not a "standalone performance" study in the sense of an independent diagnostic algorithm. The device's primary function is data acquisition and transmission, not automated diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for diagnostic accuracy. For the functional tests (e.g., QRS detection, frequency response), the "ground truth" would be the expected technical specifications and performance characteristics, typically established by design requirements and engineering standards. For the overall claim of "safe and effective," the ground truth is established by compliance with recognized standards and successful completion of the described verification and validation tests, implying that the device accurately records and transmits ECG signals as per its design.
The sample size for the training set:
- Not applicable/Not mentioned. This information would typically be relevant for machine learning-based devices. The CG-7000DX is a hardware device with firmware, not a learning algorithm product.
How the ground truth for the training set was established:
- Not applicable/Not mentioned. (See point 7).

Summary

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DEC 1 0 1999	K993799
--------------	---------

CARD GUARD
Scientific Survival LTD

	CG-7000DX Recorder/Transmitter
	510(k) Summary of Safety and Effectiveness
Submitter:	Card Guard Scientific Survival Ltd.,2 Pekeris St. P.O.B. 527Rehovot 76100, IsraelTel: 972-8-9484600Fax: 972-8-9484605
Contact Person:	Leonid Trachtenberg,Chief Engineer,Tel: 972-8-9484624E-mail: ltrachtenberg@cardguard.com)
Date Prepared:	October 31, 1999

1. Definition and Intended Use
  CG-7000DX Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, which incorporates a recording and 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 PC for viewing and processing.

The CG-7000DX allows acoustic or optical transmission. The Universal IR Adapter conveys data to the remote receiving station or local PC.

CG-7000DX is compatible and intended for use with Telemedicine 2000, the Card Guard's standard Transtelephonic Receiving Center in its LAN as well as its standalone configuration.

CG-7000DX is classified as Class II medical device.

The CG-7000DX 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, 200 edition 1992
(3) ANSI/AAMI EC11 Diagnostic Electrocardiographic Devices, 2nd edition 1991
(4) IEC-601-1-4 Medical Electrical Equipment 1996.

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Image /page/1/Figure/0 description: The image shows the logo for Card Guard Scientific Survival LTD, along with a graphic of a heart rhythm. To the right of this is the text "CG-7000DX Recorder/Transmitter" and "510(k) Summary of Safety and Effectiveness". The text appears to be describing a medical device and its compliance with safety regulations.

2. Features and Functions

Graphic display for ECG representation and device control. (1)
One screen shows 1,52 sec lead length. For viewing full length scrolling is used. (2)
Keypad with 17 keys for device control and data input. (3)
Simultaneous recording of ECG 12-leads, up to 40 ECG records. (4)
Menu selectable lead duration: 4, 8, 12, 16, and 20 seconds. (ર)
All records include a mandatory minimum 12 seconds arrhythmia trace. (6)
Recorded ECG is transmitted acoustically or optically. (7)
Low battery detection. (8)
(9) Self-test in BIT mode.
(10) Pacemaker artifact detection and marking.
Patient Cable with 10 lead wires. (11)

3. Substantial Equivalence

The CG-7000DX is an enhanced CG-7000D ECG Recorder/Transmitter (K942704). CG-7000DX is substantially equivalent to its predicate CG-7000D since both devices have:

The same intended use, and .
The same principles of operation, features and technological characteristics. .

4. Material differences

The most important innovations in CG-7000DX include:

(1) Keypad with 17 keys for device control and data input.
(2) Transmission of ECG along with its relational time and the following record IDs:
- Device ID .
- . Patient ID
- . Doctor ID
- Clinic ID .
(3) A selectable transmission speed: Real time/Rapid: x2, 33600 bit/s
(4) 10 bit digital resolution.
(5) Self-test and calibration.
(6) Heart-rate display.

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Image /page/2/Figure/0 description: The image shows the logo for Card Guard Scientific Survival LTD, along with the text "CG-7000DX Recorder/Transmitter" and "510(k) Summary of Safety and Effectiveness". The Card Guard logo includes the company name in bold text above the words "Scientific Survival LTD". To the right of the company name is a graphic that resembles an EKG readout.

5. Design Controls and Hazard Analysis

The Card Guard's product design procedure, and QA and QC policy, formalize the design and production process and assure that all respective requirements are met. In the framework of the Design Controls the laboratory testing was conducted to verify and validate the CG-7000DX compliance with all the design specifications. This included:

Verification Tests

SW Unit/Module Testing (19 tests) .
User Interface Verification Test .
Reference Voltage Verification Test ●
Clock Oscillator Verification Test .
Flash Memory Verification Test .
LPF Verification Test .
QRS Detection Test .
PM Pulse Detection Test .
Patient Cable Test .

Validation tests

Common Mode Rejection Test .
Frequency Response Test .
Input Dynamic Range Test .
Overall System Error Test .
Step Response Test .
System Noise Test .
Safe Current Test .

Environmental Tests

High and Low Temperature and Humidity Test .
Surface temperature Test .
Leakage Current Test .
. Dielectric Strength Test
Mechanical Vibration Shock Test .
Ingress of Liquids Test .
EMC Test .

The device biocompatibility was evaluated and found to be satisfactory.

The device Level of Concern criteria were evaluated and CG-7000DX was characterized as a moderate level of concern system.

The System Safety and Risk analysis conducted for CG-7000DX provided rigorous design and structural evaluation aimed at revealing potential failures or possible system flaws which could directly or indirectly effect the patient.

6. Conclusions

CG-7000DX ECG Recorder/Transmitter, constitutes a safe and reliable means for recording and transmitting standard ECG for the purpose of cardiac condition diagnosis. Its material composition and of operation present no adverse health effect or safety risks to patients when used as intended.

The conclusions drawn from clinical and laboratory testing of CG-7000DX demonstrate that the device is as safe, as effective and performs as well as or better than the legally marketed predicate device, CG-7000D ECG Recorder/Transmitter (K942704).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three birds in flight, arranged in a row. The birds are facing to the right, and their wings are spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the birds.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 0 1999

Mr. Leonid Trachtenberg Chief Engineer Card Guard Scientific Survival Ltd. 2 Pekeris St. P.O.B. 527 Rehobot 76100, Israel

Re: K993799 CG-7000DX ECG Recorder/Transmitter Regulatory Class: II (two) Product Code: DXH Dated: November 2, 1999 November 9, 1999 Received:

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 A substantially equivalent determination assumes compliance to 895. 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 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.

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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 requlation (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 Also, please note the regulation entitled, (301) 594-4639. "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,

Nancy C Burgdon for
Colin M. Whitten, Ph.D., M.D.

Celia M. Witten, Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Figure/9 description: The image shows the logo for Card Guard Scientific Survival LTD. The logo features the text "CARD GUARD" in bold, sans-serif font, with the words "Scientific Survival LTD" in a smaller font size underneath. To the right of the text is a stylized graphic resembling an electrocardiogram (ECG) waveform, with a sharp peak followed by a rounded wave and a flat line.

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 PC for viewing and processing.

The Universal IR Adapter is used for conveying data to the remote receiving station or PC.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993799

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use

(Optional Format 1-2-96)

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).