The PMP4 SelfCheck™ ECG and Card Guard Heart Screening Service are intended for self-testing by patients and by health care professionals at home and at medical settings. This 12- lead and 1-lead electrocardiogram(ECG), allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.

Specifically, the PMP4 SelfCheck™ ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:

Skipped Beats
Pounding heart (Palpitations) ●
Heart Racing or Irregular Pulse ●
Lightheadedness or Faintness ●
History of Arrhythmias ●

Device Description

PMP4 SelfCheck™ ECG allows transmitting multiple ECG recordings of 1 or 12-lead to a device (PMP+ or compatible generic PDA or mobile telephone with Bluetooth support) allowing physician to monitor the device output remotely.

Multi-functional Patient Monitor:

Built-in 1-lead ECG monitor ●
12-lead ECG monitor using an'extemal patient cable ●

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or the specific metrics typically associated with AI/algorithm performance (like sensitivity, specificity, or F1 score). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed performance metrics.

However, based on the information available, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics like accuracy, sensitivity, or specificity. Instead, it refers to:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Safety	"PMP4 SelfCheck™ ECG constitutes a safe and reliable means for transmitting ECG data. Its material composition and operation present no adverse health effect or safety risks to patients when used as intended."
Reliability	"PMP4 SelfCheck™ ECG constitutes a safe and reliable means for transmitting ECG data."
Biocompatibility	"The device biocompatibility was evaluated and found to be satisfactory."
Compliance with Design Specifications	"laboratory testing were conducted to verify and validate the PMP4 SelfCheck™ ECG compliance with all design specifications."
Risk Analysis	"The system safety and risk analysis conducted for PMP4 SelfCheck™ ECG provided rigorous design and structural evaluation aimed at revealing potential failures or possible system flaws which could directly or indirectly affect the patient."
Level of Concern	Characterized as a "moderate level of concern system."
Intended Use	Device allows transmission of 1-lead or 12-lead ECG data for display and transmission to medical professionals via communication devices to a remote server.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a sample size for a test set or discuss data provenance related to performance evaluation. It only mentions "laboratory testing" for design compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document refers to the device allowing transmission of ECG data to "medical professionals," but it doesn't detail how ground truth was established for any performance validation studies using expert review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

The document does not mention an MRMC comparative effectiveness study or any analysis of human reader improvement with or without AI assistance. The PMP4 SelfCheck™ ECG is described as a device for transmitting ECG data, not for providing AI-powered interpretation or direct assistance to human readers.

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

The document does not describe a standalone algorithm performance study. The device's function is data acquisition and transmission, with the interpretation seemingly intended for medical professionals. The warning "This non- standard 12- lead and 1- lead electrocardiogram (ECG), which is measured using the SelfCheck™ ECG. should not be used for diagnostics in comparison to the standard 12 lead ECG obtained with standard electrode placement" further indicates that the device itself is not performing diagnostic interpretation.

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

The document does not specify the type of ground truth used as it does not detail performance studies against a clinical "truth." The focus is on the device's ability to safely and reliably transmit ECG data.

8. The sample size for the training set

The document does not mention a training set sample size, as it doesn't describe the development or validation of an algorithm requiring such a set.

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

Not applicable, as no training set for an algorithm is discussed.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

3 2005 MAR

Card Guard Scientific Survival Ltd. c/o Ms. Na'ama Oren QA & Regulatory Specialist 2 Pekeris St. P.O.B. 527 Rehovot 76100 ISRAEL

Re: K042254

Trade Name: PMP4 SelfCheck™ ECG Regulation Number: 21 CFR 870.2920 Regulation Name: Transmitters and Receivers, Electrocardiograph, Teleplione Regulatory Class: II (two) Product Code: DXH Dated: December 29,2004 Received: January 03,2005

Dear Ms. Oren:

This letter corrects our substantially equivalent letter of January 13,2005 regarding the incorrect contact person.

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 (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.

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Page 2 - Ms. Na'ama Oren

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 continue 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Bhimmer 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

510(k) Number: K042254/S2

Device name: PMP4 SelfCheck™ ECG

Specifically, the PMP4 SelfCheck™ ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:

Skipped Beats
Pounding heart (Palpitations) ●
Heart Racing or Irregular Pulse ●
Lightheadedness or Faintness ●
History of Arrhythmias ●

ﮯ Prescription Use AND/OR Over-The-Counter Use V (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

", "l

Page 1 of 1

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	PMP4 SelfCheck™ ECG
	510(k) Summary of Safety and Effectiveness

JAN 13 2005

Submitter:	Card Guard Scientific Survival Ltd.,
	2 Pekeris St. P.O.B. 527
	Rehovot 76100, Israel
	Tel: 972-8-9484000
	Fax: 972-8-9484044
Contact Person:	Na'ama Oren,
	QA and Regulatory Specialist
	Tel: 972-8-9484045
	E-mail: naamao@eardguard.com
Date Prepared:	December 19.2004

Definition 1.

Multi-functional Patient Monitor:

Built-in 1-lead ECG monitor ●
12-lead ECG monitor using an'extemal patient cable ●

Intended Use 2.

The PMP4 SelfCheck™ and Card Guard Heart Screening Service are intended for selftesting by patients and by health care professionals at home and at medical settings. This 12- lead and I-lead electrocardiogram (ECG), allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.

Specifically, the PMP4 SelfCheck™ ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:

. Skipped Beats
Pounding heart (Palpitations) ●
Heart Racing or Irregular Pulse .
Lightheadedness or Faintness ●
. History of Arrhythmias

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Image /page/4/Picture/0 description: The image shows the logo for Card Guard. The logo has the words "CARD GUARD" in bold, black letters. Underneath the words is a thin black line, and below that are smaller words that are difficult to read. To the right of the logo is a line graph that resembles an EKG.

Contraindications for Use:

In order to use this service, the patient must be able to perform all of the following:

Read and understand the User's Manual ●
Place the PMP4 SelfCheck™ ECG on his/her chest and hold it steadily for at . least 30 seconds.
Hear the "beeps" for low battery. .
. Speak and understand English.
Operate a PDA or cell phone (hand-held devices) ●
Operate a simple, push-button device.

Due to the possible seriousness of the abnormal heart rhythms that can be associated with these conditions, persons who have been diagnosed with the following conditions should consult their physician before using this service:

Blockage of the arteries of the heart
. Heart valve problems
Heart transplant ●
Congestive heart failure ●
Loss of consciousness ●

If the patient has any of these conditions. CG will need to obtain authorization from their physician within 35 days of enrollment in the service.

Warning:

This non- standard 12- lead and 1- lead electrocardiogram (ECG), which is measured using the SelfCheck™ ECG. should not be used for diagnostics in comparison to the standard 12 lead ECG obtained with standard electrode placement. Use of SelfCheck™ ECG with 12-lead cable is by physician prescription only. This device should not be used with pacemakers or implanted defibrillators and cannot predict or diagnose a heart attack or be used for chest pain monitoring. The SelfCheck™ ECG is not a defibrillation proof device.

Need for Signed Physician Agreement (12- lead ECG):

Your agreement indicates you understand that CG (or affiliate) will contact your physician to verify in writing that you are their patient and that they are willing to be contacted in cases where there are clinically significant events involving your care.

Your agreement indicates you understand that ifwritten verification is not received from your physician within 35 days of your cnrollmcnt, you will not be able to utilize any aspects of the CG (or affiliate) service until such verification is reccived by CG (or affiliate).

Your agreement certifies you understand that this scrvice is not a substitute for physician care and that this is only a screening service.

This document contains proprietary information of	Document No.	Rev.	Page
CARD GUARD Scientific Survival Ltd.	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Image /page/5/Picture/0 description: The image shows the words "CARD GUARD" in bold black letters above the words "Scientific Survival LLC" in smaller, lighter letters. To the right of the words is a line graph that resembles an electrocardiogram (EKG) reading. The EKG line has a sharp peak, a rounded hill, and a flat line.

Low Battery detection and audio warning .

5. User Interface

The PMP4 SelfCheck™ ECG user interface incorporates the following controls and signals:

On/off control button
SEND control button (optional) ●
Fluctuating transmission sound ●
Low battery warning

Substantial Equivalence 6.

The substantially equivalence to the following predicate devices is claimed:

CG-2211	1 Lead ECG Transmitter (OTC)	KO12223	Decision Date 07/28/01
CG-7100	12 Lead Personal ECG Transmitter	K964836	Decision Date 07128197

PMP4 SelfCheck™ ECG is schematically identical to CG-2211 ECG Transmitter K012223, except it includes a 12 Lead option and uses the Bluetooth technology instead of transtelephonic transmission. It is also proposed as a non-prescription device (OTC).

The Intended use is similar: self-testing by patients. Both devices transmit a limited period of heart activity.

The common feature with CG-7100 (K964836) ECG Transmitter is the 12- Lead option. Both, the PMP4 SelfCheck ECG and the CG-7100 should not be used for diagnostics in comparison to the standard 12 lead ECG obtained with standard electrode placement and do not provide quality ECG data. By comparing the safety tests and performance tests of the SelfCheck™ ECG to those of the CG-7100, it can be concluded that its safety and efficacy are not derogated.

Design Controls and Hazard Analysis 7.

The Card Guard's product design proccdure, and QA and QC policy, formalize the design and production process and assure that all respective requirements arc met. In the framework of the Design Controls laboratory testing were conducted to verify and validate the PMP4 SelfCheck™ ECG compliance with all design specifications.

The device biocompatibility was evaluated and found to be satisfactory.

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Image /page/6/Picture/0 description: The image shows the logo for Card Guard. The text "CARD GUARD" is in bold, black letters. Underneath the text is the phrase "More than Survival ITQ" in a smaller font. To the right of the text is a line graph that resembles an EKG.

The device Level of Concern criteria were evaluated and PMP4 SelfCheck™ ECG was characterized as a moderate level of concern system.

The system safety and risk analysis conducted for PMP4 SelfCheck™ ECG provided rigorous design and structural evaluation aimed at revealing potential failures or possible system flaws which could directly or indirectly affect the patient.

8. Conclusions

PMP4 SelfCheck™ ECG constitutes a safe and reliable means for transmitting ECG data. Its material composition and operation present no adverse health effect or safety risks to patients when used as intended.

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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).