GLOBALCARDIO

K111320 · Cardiocomm Solutions, Inc. · DSH · Oct 7, 2011 · Cardiovascular

Device Facts

• Record ID: K111320
• Device Name: GLOBALCARDIO
• Applicant: Cardiocomm Solutions, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Oct 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Software as a Medical 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, 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 Story

GlobalCardio is a web-based cardiology data management system (ASP model) for storing/reporting ECG and cardiac data (arrhythmia, pacemaker, ICD, stress test, rehab). Inputs include ECG data from single/multilead devices via keyboard, mouse, barcode, sound card, serial, or IrDA ports. System uses a QRS algorithm to analyze 12-lead ECGs, generating measurements and textual interpretations. Operated by clinicians/technicians in hospitals/clinics via web browser. Data stored in secure, firewall-protected central or client-site databases. Output displayed on monitors or printed. Clinicians use output to support clinical judgment; system does not provide automated diagnosis or alarms; human intervention required for all clinical decisions.

Clinical Evidence

Bench testing only. Verification and validation activities included scenario validations, report viewing/customization testing, algorithm confirmation testing, and functional testing. No clinical data presented.

Technological Characteristics

Web-based database system; ASP model; runs on IBM-compatible PCs via Microsoft Internet Explorer. Connectivity via Internet; secure firewall-protected data warehousing. Supports multi-user access. Data input via keyboard, mouse, barcode, sound card, serial, or IrDA. Software-based QRS algorithm for ECG measurement and interpretation.

Indications for Use

Indicated for use by cardiologists, GPs, ECG technicians, nurses, and monitoring staff to manage, store, and report ECG data from single/multilead sources. No specific patient age or gender restrictions; intended for patients requiring cardiac monitoring or ECG analysis in clinical settings. Not for diagnosis or medical alarms; requires human intervention.

Regulatory Classification

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.

Predicate Devices

• GlobalCardio (K033037)
• CardioView 32 Review Module (K083321)

Submission Summary (Full Text)

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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 [e-mail] [phone] [phone] CardioComm Solutions Inc. Submitter of 510(k): 201-3060 Cedar Hill Rd. Victoria, BC, V8T 3J5 Mona Palfreyman [e-mail] 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.

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.

OCT - 7 2011

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#### 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.

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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.

| 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.

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#### 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 [phone] or [phone] 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

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.

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)

A

Poivision Sign-C ivision of Cardiovascular Devices

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**510(k) Number** K111320