HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME by CARDIO COMM SOLUTIONS, INC.

The HeartCheck™ Pen Handheld device with GEMS Home software is an over-thecounter device intended to record, store, transfer single channel Heart Rhythm signals and, for users under a physician's care, display Heart Rhythm waveforms. The HeartCheck™ Pen Handheld device along with GEMS Home software is not intended to substitute a hospital diagnostic ECG device. The device is not intended for simultaneously recording and transmitting a user's Heart Rhythm. Users with an implanted pacemaker or a defibrillator are not recommended to use this device. GEMS Home is a simple software user interface for managing Heart Rhythm recordings and associated data.

Device Description

The applicant device of HeartCheck Pen is a handheld device. which can record cardiac event data. As delivered to the end user. Heart Rhythm recordings are made on the HeartCheck™ Pen Heart Rhythm device and uploaded to GEMS Home, but the Heart Rhythm Waveform itself is not visible to or accessible by the user. GEMS Home allows the user to manage their personal information, their Heart Rhythm recordings and upload their Heart Rhythm recordings for Physician Review. Once the end user is under the guidance of a qualified Health Care Professional (e.g. Physician. Trained Technician. etc.), the Health Care Professional can use the access-controlled "Physician Review" section of the existing CardioComm Solutions Rx Only devices to initiate a process to "unlock" the GEMS Home Software and the HeartCheck™ Pen Heart Rhythm device to allow the end user to see their Heart Rhythm Waveforms in the GEMS Home software and on the device. Access to the "Physician Review" component of the existing CardioComm Solutions Rx Only devices is restricted to Health Care Professionals. The "unlock" feature is not accessible to anyone other than qualified Health Care Professionals and can only be initiated once the user has uploaded their collected HR Data from the GEMS Home.

The Heart Rhythm Monitor is made up of signal input unit, signal amplify unit. CPU. Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our manufacturing partner Beijing Choice Electronic Technologies.

The HeartCheck™ Pen Heart Rhythm device is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and can be later uploaded for review by qualified Health Care Professionals for confirmation of these symptoms.

The applicant device has a "data upload" function which is controlled by hardware; it can transmit the data measured by the device to a computer via the USB port. The "GEMS Home" software is used to store and review the data collected by the HeartCheck Pen Heart Rhythm Monitor. The "GEMS Home" software is installed onto the computer from a CD ROM by the user. The "GEMS Home" software CD ROM is an accessory of the applicant device.

The applicant device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor.

AI/ML Overview

The provided text describes performance testing for the HeartCheck™ Pen Handheld device with GEMS Home software, but it does not explicitly state specific acceptance criteria or report device performance against those criteria in a tabular format. Instead, it lists the standards the device complies with and the types of tests performed.

Therefore, many sections of your requested output cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (as stated in document)	Reported Device Performance (as stated in document)
Electrical Safety	Compliance with IEC60601-1	Device complies with IEC60601-1
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Device complies with IEC 60601-1-2
ECG Performance	Compliance with AAMI EC38 standards	Device complies with AAMI EC38 standards
Low Voltage Indication	Not explicitly stated	Low Voltage Indication Validation Test was performed. Results not provided.
Mechanical Shock	Not explicitly stated	Shock Test was performed. Results not provided.
Random Vibration	Not explicitly stated	Random Vibration Test was performed. Results not provided.
Sinusoidal Vibration	Not explicitly stated	Sinusoidal Vibration Test was performed. Results not provided.
Heart Rate Accuracy	Not explicitly stated	Heart Rate Accuracy Test (Shelf Life) was performed. Results not provided.
Temperature & Humidity	Not explicitly stated	High, low temperature & humidity Test were performed. Results not provided.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document.

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

Number of Experts: Not specified in the provided document. The document mentions "qualified Health Care Professionals (e.g. Physician. Trained Technician. etc.)" for review of recorded data, but this is in the context of the device's intended use and not for establishing ground truth in performance testing.
Qualifications of Experts: Not specified in the provided document for performance testing.

4. Adjudication method for the test set

Adjudication Method: Not specified in the provided 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

MRMC Study: Not mentioned in the provided document. The device is a handheld heart rhythm monitor, and the study described focuses on technical performance rather than a comparative effectiveness study involving human readers and AI assistance.

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

Standalone Performance: The performance testing described focuses on the device's technical performance (electrical safety, EMC, heart rate accuracy, mechanical robustness, environmental resistance). It does not explicitly mention "algorithm only" performance. The device records and stores signals for later review by professionals, suggesting a human-in-the-loop component for interpretation of the waveforms in its intended use.

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

Type of Ground Truth: Not specified in the provided document. For tests like "Heart Rate Accuracy," it is implied that a reference standard was used, but the nature of that standard is not detailed.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/mentioned. The device is a monitor, not an AI/ML algorithm that undergoes a training phase as typically understood in machine learning. Its performance is validated against compliance standards and specific functional tests.

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

Ground Truth for Training Set: Not applicable. As noted above, this document does not describe an AI/ML algorithm requiring a training set with established ground truth in this context.

Summary

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DEC 2 2 2011

510(k) SUMMARY (as required by 807.92(c))

Regulatory Correspondent:	AJW Technology Consultants, Inc.962 Allegro LaneApollo Beach, FL 33572Jon Wardwardjp@ajwtech.comPhone: 813-645-2855Fax: 813-677-4787
Submitter of 510(k):	CardioComm Solutions, Inc.201-3060 Cedar Hill RoadVictoria, BC V8T 3J5Mona Palfreymanmona@cardiocomm.comPhone: 250-744-1122Fax: 250-744-1866
Date of Summary:	March 31, 2011
Trade/Proprietary Name:GEMS Home	HeartCheck Pen Handheld Heart Rhythm with
Classification Name:	Class II
Product Code:	DPS
Regulation:	870.2340
Intended Use:

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Device Description:

The applicant device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor.

Predicate Device(s):

Handheld ECG Monitor MD100 (K093872) Read My Heart Model RMH 2.0 (K052303)

Substantial Equivalence:

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The proposed device is substantial equivalent to the Handheld ECG Monitor MD100 (K093872) and Read My Heart Model RMH 2.0 (K052303) devices. The proposed device has a similar intended use, technological, and design characteristics as the predicate device. Any minor differences do not introduce new issues of safety or effectiveness.

Performance Testing:

The device complies with IEC60601-1, IEC 60601-1-2 and AAMI EC38 standards. A Low Voltage Indication Validation Test, Shock Test, Random Vibration Test, Sinusoidal vibration Test, Heart Rate Accuracy Test (Shelf Life) and High, low temperature & humidity Test were all performed on the applicant device to validate its performance.

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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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2011

Cardio Comm Solutions, Inc. c/o Jonathan Ward President AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572

Re: K111159

Trade Name: HeartCheck Pen Handheld ECG with GEMS Home Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: December 16, 2011 Received: December 19, 2011

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreases of to the enactment date of the Medical Device Amendments, or to conninered prior to 1118) 2011-12-11 in accordance with the provisions of the Federal Food, DNA 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 1 ou may, mereloro, manel also as 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), If your device is classified (600 a00 - 5) . 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. publish turner announce of a substantial equivalence determination does not mean I has be advised that I Dris beaund that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I cocraf statutes and regairements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Jonathan Ward

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Detlef Stein

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

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510(k) Number (if known):

Device Name: HeartCheck Pen Handheld Heart Rhythm with GEMS Home

The HeartCheck™ Pen Handheld with GEMS Home software is an over-the-counter device intended to record, store, transfer single channel Heart Rhythm signals and, for users under a physician's care, display Heart Rhythm waveforms. The HeartCheck™ Pen Handheld device along with GEMS Home software is not intended to substitute a hospital diagnostic ECG device. The device is not intended for simultaneously recording and transmitting a user's Heart Rhythm. Users with an implanted pacemaker or a defibrillator are not recommended to use this device. GEMS Home is a simple software user interface for managing Heart Rhythm recordings and associated data.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
12/22/2011
510(k) Number K111159

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Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).