GlobalCardio is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. GlobalCardio includes a QRS Algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation.

GlobalCardio will be accessed over the Internet and data will be stored at either the client site or at the central GlobalCardio data warehouse. Data will be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their patients' needs. GlobalCardio is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GlobalCardio does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

Device Description

GlobalCardio is a cardiology software product, delivered over the web using the Application Service Provider (ASP) model. GlobalCardio operates on IBM compatible PCs and runs within an Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an interface for health care professionals to input, store, query and output data from a centrally hosted, or client based relational database.

The product is a web-based database system for the secure storage of all aspects of a patient's cardiology record including: arrhythmia follow-up and diagnosis, transtelephonic pacemaker follow-up, implantable cardioverter defibrillator (ICD) follow-up, in-clinic follow-up, 12 Lead ECG testing, cardiac rehabilitation data, stress test data pathological diagnosis, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries.

GlobalCardio is a comprehensive ECG management system. GlobalCardio is sold in two ways:

Per-use or fee-for-service. Software is not shipped and installed, but instead customer accounts are set up for access and record management from the centrally hosted web application. Login IDs and passwords are created for each authorized client. Databases reside in the secure, firewall protected, warehouse at the application host site.
Technology licensing. GlobalCardio technology is licensed to another company which then hosts a complete service, as described above, including secure data warehousing.

All activity on GlobalCardio is recorded by User ID. User IDs are provided for each customer to access their own secure database(s).

GlobalCardio is designed as a multi-user system capable of supporting large volumes of simultaneous users.

Data can be entered via keyboard, mouse, bar code reader, sound card, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed.

GlobalCardio is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

The purpose of this submission is to include the 12 Lead ECG and Digital Device Integration modules.

AI/ML Overview

The provided 510(k) summary for K111320 (GlobalCardio) describes performance testing as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases." It then lists the types of activities:

Scenario validations
Report viewing and customization testing
Algorithm confirmation testing
Device functional testing

However, specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity, or specific functional requirements) and the quantitative results of these tests are not provided in this 510(k) summary. The summary only confirms that "predetermined acceptance criteria were met in all cases."

2. Sample Size Used for the Test Set and Data Provenance:

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly mentions "verification and validation activities."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The summary does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The summary does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

There is no mention of an MRMC comparative effectiveness study being performed. The device is a data management tool and includes a QRS algorithm to produce measurements and textual interpretation, but it explicitly states: "GlobalCardio does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data." This suggests the device is not intended as a standalone diagnostic tool that would typically undergo an MRMC study to compare performance with human readers.

6. Standalone (Algorithm Only) Performance:

An "Algorithm confirmation testing" was performed, indicating that the QRS algorithm's performance was evaluated. However, specific metrics, results, or the methodology of this standalone evaluation are not disclosed in this summary. The device's intended use emphasizes human oversight, so while the algorithm was tested, its standalone performance isn't presented as a primary performance metric for regulatory purposes.

7. Type of Ground Truth Used:

The summary does not explicitly state the type of ground truth used for "Algorithm confirmation testing." Given the nature of a QRS algorithm, it would typically involve comparison against a gold standard derived from expert consensus or highly accurate, manually annotated ECG recordings.

8. Sample Size for the Training Set:

The 510(k) summary does not provide any information regarding the sample size used for the training set of the QRS algorithm.

9. How Ground Truth for the Training Set Was Established:

The 510(k) summary does not provide any information on how the ground truth for the training set was established.

Summary

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K-111320

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

AJW Technology Consultants Inc. Regulatory Correspondent: 962 Allegro Lane Apollo Beach, FL, 33572 Jon Ward wardjp@ajwtech.com (813) 645-2855 (813) 645-2856 CardioComm Solutions Inc. Submitter of 510(k): 201-3060 Cedar Hill Rd. Victoria, BC, V8T 3J5 Mona Palfreyman mona@cardiocomm.com Date of Summary: September 9, 2011 Trade/Proprietary Name: GlobalCardio Classification Name: Medical magnetic tape recorder (21 CFR 870.2800, Product Code DSH) Common Name: Health monitoring data management device

Intended Use:

GlobalCardio is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. GlobalCardio includes a QRS Algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation.

OCT - 7 2011

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Device Description:

2/3

211 1320

GlobalCardio is a comprehensive ECG management system. GlobalCardio is sold in two ways:

Per-use or fee-for-service. Software is not shipped and installed, but instead customer . accounts are set up for access and record management from the centrally hosted web application. Login IDs and passwords are created for each authorized client. Databases reside in the secure, firewall protected, warehouse at the application host site.
Technology licensing. GlobalCardio technology is licensed to another company . which then hosts a complete service, as described above, including secure data warehousing.

All activity on GlobalCardio is recorded by User ID. User IDs are provided for each customer to access their own secure database(s).

GlobalCardio is designed as a multi-user system capable of supporting large volumes of simultaneous users.

The purpose of this submission is to include the 12 Lead ECG and Digital Device Integration modules.

Predicate Device:	GlobalCardio (K013354)
	CardioView 32 Review Module (K083321)

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Substantial Equivalence:

The proposed device is substantial equivalent to the GlobalCardio (K033037) device. The proposed device has t similar intended use technological, and design characteristics as the predicate devices. Any minor differences do not introduce new issues of safety or effectiveness.

3/3

Performance Testing:

Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases. The activities included scenario validations, report viewing and customization testing, algorithm confirmation testing, and device functional testing.

Conclusion:

The results of the non-clinical performance testing and device comparison demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

CardioComm Solutions, Inc. c/o Mr. Jon Ward AJW Technology Consultants Inc. 962 Allegro Lane Apollo Beach, Florida 33572

OCT - 7 2011

Re: [510(k)] K111320

Trade/Device Name: GlobalCardio Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: DSH, DPS Dated: September 13, 2011 Received: September 13, 2011

Dear Mr. Ward:

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 misbianding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations of class III (PMA)
found in the Code of Federal Recultive - Title as 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.

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Page 2 - Mr. Jon Ward

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); medical device reporting (reporting of medical 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 331-542 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/CDRHQffices/ucm115809.htm1 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/ReportalProblem/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.

سل ا

Sincerely yours,

Ram D. Zuckerman, M.D.

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): K111320

Device Name: GlobalCardio

Prescription Use: X Prescription Use: Δ

AND/OR

Over-The-Counter Use: (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)

Poivision Sign-C ivision of Cardiovascular Devices

Page 1 of 1

510(k) Number K111320

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).