CARDIONAVIGATOR +

K051960 · Del Mar Reynolds Medical, Ltd. · DXH · Aug 19, 2005 · Cardiovascular

Device Facts

• Record ID: K051960
• Device Name: CARDIONAVIGATOR +
• Applicant: Del Mar Reynolds Medical, Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CardioNavigator Plus, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.

Device Story

CardioNavigator Plus is a software-based database management system and control panel for Del Mar Reynolds cardiology monitoring devices. It replaces dedicated software previously used for individual devices. Input consists of patient cardiology data (ECG or blood pressure) downloaded from compatible monitoring devices. The software organizes this data into a common database, allowing clinicians to configure devices and retrieve reports. It operates on a PC, either as a standalone unit or in a server-workstation configuration. The user interacts with the software via a graphical interface, selecting device-specific icons to access original device operation screens. It does not perform ECG analysis itself but can interface with the Pathfinder Holter analysis program. The system facilitates centralized data management, enabling clinicians to review patient records and manage device settings efficiently.

Clinical Evidence

No clinical data. The device was validated through non-clinical testing, including validation of the software by itself and in conjunction with associated Del Mar Reynolds Medical devices.

Technological Characteristics

Software-based database management system; operates on standard personal computers (PC); supports standalone or server-workstation network configurations; provides a centralized interface for device configuration and data retrieval; compatible with existing and future Del Mar Reynolds monitoring products.

Indications for Use

Indicated for clinicians wishing to consolidate, organize, and manage databases for compatible Del Mar Reynolds Medical monitoring products (ECG or blood pressure) and to serve as a control panel for device configuration and data retrieval.

Regulatory Classification

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.

Predicate Devices

• CardioNavigator (K011345)

Reference Devices

• Pathfinder Holter analysis program

Submission Summary (Full Text)

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## CardioNavigator Plus 510(k) Summary

## Kosiged

Page A 1

Del Mar Reynolds Medical Ltd. Special 510(k) Submission CardioNavigator Plus

> 510(k) Summary June 24, 2005

- Submitter Information (1)
Name: Del Mar Reynolds Medical Ltd.

Address:

1 Harforde Court John Tate Court Hertford, Herts SG137NW ENGLAND

Telephone Number: 44-1992-507700

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

- (2) Name of Device
Trade Name: CardioNavigator Plus Common Name: Central Data Base for Cardiology Devices Classification name: Computers and Software, Medical

- Equivalent legally marketed devices. (3)
- 1. Del Mar Reynolds Medical Ltd. CardioNavigator, K011345
- (4) Description

CardioNavigator Plus, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds monitoring products and

AUG 1 9 2005

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KOSIG60

CardioNavigator Plus 510(k) Summary

also to act as a "control panel" for these products. The software that formerly was used with these devices has been transferred to sections of CardioNavigator Plus. The program itself is supplied with all products.

The individual products are all data-gathering devices used to collect cardiology patient data (ECG or blood pressure). These devices were previously sold with dedicated software programs that allow the devices to be set-up or configured both to program the devices, and to receive downloaded data from the devices and produce reports. In general, the dedicated programs also have a database uniquely for data from that device. As noted before, these dedicated databases are replaced by the Cardio Navigator Plus database.

CardioNavigator Plus maintains a common cardiology database for the data collected by the compatible devices, and also permits the user to operate the various devices in a manner identical to the way they were operated as individual products. As a common database, CardioNavigator Plus stores data collected from each patient in the section of the database dedicated to that patient. When used as a method for operating the device, the user selects the icon associated with the device. The user then sees the opening screen for the operation of that device, and all succeeding screens, as they were seen when the device was used with its dedicated program.

CardioNavigator Plus has no capacity for analyzing electrocardiograms. When CardioNavigator Plus is uses with the Pathfinder Holter analysis program, the Pathfinder program is loaded into the same computer, and CardioNavigator can call Pathfinder, but there are no other links.

CardioNavigator Plus can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. CardioNavigator Plus will work with products already owned by the user, or with new products (included in the list of compatible products) that the user may purchase later.

CardioNavigator Plus will work on a single computer, but it has also been reconfigured to use as a server-workstation system (where the server and the workstation are still personal computers). If a single CardioNavigator Plus will still work on a single computer, but it has been re-configured to use a server-workstation system (where the server and the workstation are still personal computers). If a single computer is used, the server and workstation are combined in that computer

## Intended Use (ર)

CardioNavigator Plus, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical monitoring products and also to act as a "control panel" for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.

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K051960

Page A 3

(6) Performance Data

(a) Non-clinical tests

CardioNavigator Plus has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices.

(b) Clinical tests

Clinical tests are not necessary, since CardioNavigator Plus uses the same technology as the predicate device.

(c) Conclusions

CardioNavigator Plus is equivalent in safety and efficacy to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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AUG 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Del Mar Reynolds Medical, Inc. c/o George Meyers, Sc.D. President Medsys, Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604

Re: K051960

Trade Name: CardioNavigator Plus Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: July 14, 2005 Received: July 19, 2005

Dear Dr. Meyers:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) presidentially equivalent (for the indications
referenced above and have determined the device is substantially interests a for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manator provide in the Medical Device American brug commerce province to May 20, 1970, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a provide approval approval special and Cosment Act (Act) that to hot require approval controls provisions of the Act. The Act. The Y ou may, therefore, market the device, believe to the go
general controls provisions of the Act include requirements for annual registration, includes and general controls provisions of the 110 libeling, and prohibitions against 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 (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation, EDA may be subject to such additional controlist Existing mays of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Peacharing your device in the Federal Register.

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Page 2 - Dr. George Meyers

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase or advisou may i bromination that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must or any I catal statures and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR_Part 8Q1); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comiles pour device as described in your device as described in your Section 510(k) This letter will and in yourse out finding of substantial equivalence of your device to a legally prematice notineation. "The 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 If you desire of Compliance at [phone]. 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 other general international 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,

Blymmima 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 (if known): K051960

Device Name: CardioNavigator Plus

Indications for Use:

CardioNavigator Plus, a software product, is a computer program intended to organize and manage the Catabases for compatible Del Mar Reynolds Monitoring products and also to act as a "control panel" for these ualabases for compation bet rial respects to consolidate the databases of his Del Mar Reynolds products.

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Prescription Use _ X (Part 21 CFR 801 Subpart D)

. '

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

تت تت ته ته

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumena

(Division of Cardiovascular Devices (Division of Cardiovas (D 151960 510(k) Number_

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