GLOBALCARDIO

K013354 · Cardiocomm Solutions, Inc. · DSH · Jan 31, 2002 · Cardiovascular

Device Facts

• Record ID: K013354
• Device Name: GLOBALCARDIO
• Applicant: Cardiocomm Solutions, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Jan 31, 2002
• 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 data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio will be accessed over the internet. 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) operating as a client-server application via Microsoft Internet Explorer. It functions as a secure, centralized database for storing and retrieving cardiac records, including ECGs, arrhythmia/pacemaker follow-up, cardiac rehabilitation data, and physician notes. Data input occurs via keyboard, mouse, bar code reader, sound card, or serial/parallel ports. The system supports multi-user access with secure, firewall-protected databases. It does not perform automated diagnosis or generate medical alarms; it serves as a repository for clinical data to be reviewed and interpreted by healthcare professionals (cardiologists, nurses, technicians). The system facilitates clinical decision-making by providing organized access to patient history and cardiac reports. It is not life-supporting or life-sustaining.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Web-enabled client/server application; utilizes Internet/Intranet connectivity. Database-driven storage for cardiac records. Supports standard PC peripherals (keyboard, mouse, serial/parallel ports). Security features include user IDs, passwords, and firewall-protected databases. No specific materials or energy sources defined beyond standard PC hardware requirements.

Indications for Use

Indicated for use by cardiologists, general practitioners, cardiac/ECG technicians, nurses, and monitoring service technicians to manage, store, retrieve, and report cardiac data, including ECGs, arrhythmia follow-up, pacemaker follow-up, cardiac rehabilitation data, and clinical history. Intended for use in clinics, hospitals, and physician offices. No contraindications specified.

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

• Mercator (K982384)
• Brentwood PC-ECG (K955023)

Submission Summary (Full Text)

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JAN 3 1 2002

Image /page/0/Picture/1 description: The image shows the logo for CardioComm Solutions Inc. The logo features a stylized heart symbol above the company name. The heart symbol is formed by two curved lines that meet at the bottom and a circle in the middle. The text "CARDIOCOMM" is in bold, and "SOLUTIONS INC" is in a smaller font size below it.

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# Submitter

| Name: | CardioComm Solutions Inc. |
|----------|-----------------------------------------------------------------|
| Address: | 201 – 3060 Cedar Hill Road<br>Victoria, B.C., Canada<br>V8T 3J5 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Angela Halwas |
| Date: | January 29, 2002 |

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted This summary of 810(k) balely entronomis of SMDA 1990 and 21 CFR 807.92. .

The assigned 510(k) number is: K013354.

### Device

GlobalCardio Name:

Substantial Equivalence is claimed to: Mercator (K982384) Brentwood PC-ECG (K955023)

### Description:

GlobalCardio is a cardiology software product, delivered over the web using the GrobalCardio is a carcleiogy (ASP) model. GlobalCardio operates on IBM Application Dervice Provider in Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an GlobalCafulo operator as a client of the more of the 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 The product is a wob bardiology record including: arrhythmia follow-up and aspecis of a pation: 0 caranology maker follow-up, cardiac rehabilitation data, diagnosis, trans-telephonic passmakis, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries.

GlobalCardio is a comprehensive ECG management system that is to be sold on GlobalCardio is a comprenents 200 mare will not be shipped and installed, but a per-use of icc-ior-service business and record management from father, customer accounts which in the sand passwords will be created

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# GlobalCardio (K013354) -- 510(k) Summary

for each authorized client. All activity on GlobalCardio will be recorded by User for each admonized bilent. An access their own somer to access their own secure ID: User IDs will be provided for ouch casino, firewall protected, warehouse database(s). Databases may roomizations computer network, managed by their own firewall.

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 Data Can De Chicand stored to and retrieved from any computer media. port, or frer port, a displayed on the computer monitor or printed.

GlobalCardio is not a life-supporting or life-sustaining system. It is intended that GlobalCardio is not a mo capporting be involved before any impact on health occurs. competent numan interrontion be incontract and interpret the data.

### Intended Use:

GlobalCardio is intended to be used as a data management tool for cardiologists, GlobalOardio intoneourdiac or ECG technicians, nurses, monitoring service general practitions, and other cardiac related institutions or care givers to store, retrieve, technicians; and binor safahas roll ECG data acquired from a variety of ECG communicate und reggle and multi-lead ECG devices. GlobalCardio will be sources including bingle and mailate will be stored at either the client site or at accessed over the miomer an warehouse. Data will be secure, and with separate the Central Click ourdle duta nes will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their matialing patient ourdice is intended for use in clinics, hospitals, physician's patients Treeus. OlobalOurche is interns 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.

# Technological Characteristics:

There are additional features contained in GlobalCardio, which are not available in the predicate devices. These will be explained in the following paragraphs.

GlobalCardio is a web-enabled client/server application designed for setup as an GlobalGardio is a wob Chables chance there conser based and has been developed intranover intornet ASP tools. The predicate products do not have these features, using Microson Rion 10esktop PC applications. This architecture enables the as they are tradilional acom. Spection in a new environment (the world wide web. and local Intranets) but in no way changes the clinical aspects of intended use for the product.

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GlobalCardio (K013354) -- 510(k) Summary

GlobalCardio includes the ability to store cardiac rehab information. This feature allows for the collection of patient data as related to protocols defined for a allows for the collection of patient addition of these protocols and GlobalCardio is merely a tool for retaining and reporting this information.

The elements listed in the sections for Security and Audit Tracking pertain only to The elements insted in the costions provide enhanced security levels exceeding the GlobalCardio. These fouter of the two predicate devices. These elements ensure security available in only be seen/used by intended persons. The Audit Tracking that data can only be scurity by way of tracking all activity as it perfains to a provides additional obony by by these enhanced security features enable Specific, Secaro, abon to function in existing and new PC operating the GlobalCardio application canne the clinical aspects of intended use for the product.

GlobalCardio has substantially equivalent indications for use, and similar target population, design, performance, and feature set compared to the predicate population, action, porternally equivalent to the combination of the predicate devices.

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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 symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2002

Ms. Angela Halwas Quality System Manager CardioComm Solutions, Inc. 201 - 3060 Cedar Hill Road Victoria, British Columbia Canada

Re: K013354

Trade Name: GlobalCardio Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: DSH Dated: January 9, 2002 Received: January 10, 2002

### Dear Ms. Halwas:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premated is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regary marketed provice Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the chaculeur with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while toproval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, sucject to answares for ammal registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the rict merate requirements of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into exist one regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may may be subject to such additional controls: Extrang many to 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Rogister be found in the Code of Featur Regeralises
publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Angela Halwas

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a subscriber with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmanon alat your are res by other Federal agencies. You must or any Federal statutes and regulations administered or registration and listing (21 l
comply with all the Act's requirements, including, but not time the securements as set comply with all the Act s requirements, monating practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Fart 800); government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the market of a low and starticles as your device to legal This letter will anow you to begin mancemig your article equivalence of your device to a legally premarket notification. The PDA intellig of successification 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 CFF Part 801 and If you desire specific advice for your device diagnostic devices), please contact the Office of additionally 21 CPR Part 809.10 for in vitto unestions on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and adv Compliance at [phone]. Additionally, 16. queenses of 9 594-4639. Also, please note the your device, prease comace the office of every of concerners on the times of contributions were and the regulation entitled, "Misoranding by reference to promoter the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Lh

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

GlobalCardio Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

GlobalCardio is intended to be used as a data management tool for cardiologists, general GlobalCardio is intended to be used as a nationing service technicians, and other
practitioners, cardiac or ECG technicians, nurses, munitoring service technicians, and repor practitioners, cardiac or ECG technicals, nurses, nother and report ECG and cardiac related institutions or care given induding single and multi-lead ECG devices.
ECG data acquired from a variety of ECG sources including single at multi-lead ECG devi ECG data acquired from a variety of ECG sources including single of either the client site GlobalCardio will be accessed over the intentions. Data will be secure, and with separate data
or at the central GlobalCardio data warehouse. Data will be secure, and with or at the central GlobalCardio data will be able to access specific modiles for managing patient
stores for each client. Users will be able to access specific modiles for a stores for each client. Users will be actess specinents' needs. GlobalCardio is
cardiac related data such as arthythmia data that fiftheir patients' needs. GlobalCardio de cardiac related data such as arrhythmla data that it then panonee a medical doctor deems
intended for use in clinics, hospitals, physical is offices, or anywhere a medical do intended for use in clinics, hospitals, physican s oneos, eli call alarms. It is intended that
appropriate. GlobalCardio does not offer diagnosis or medical alarns. Clinical appropriate. GlobalCardio does not only of the dagliosis on health occurs. Clinical
competent human intervention be involved before any impact on health competent numan intervention be involved and interpret the data.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) There of the forme Concurrence of CDRH, Office of Device Evaluation (ODE)

he

Division of Cardiovascular & Respirat
510(k) Number K013354

(Optional Format 3-10-98)