CARDIONAVIGATOR + by DEL MAR REYNOLDS MEDICAL, LTD.

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 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 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

AI/ML Overview

Based on the provided 510(k) summary for CardioNavigator Plus, here's an analysis of the acceptance criteria and study information:

It's important to note that the CardioNavigator Plus is a software product for organizing and managing databases for compatible cardiology monitoring devices and acts as a "control panel." It does not analyze electrocardiograms or other medical data. Therefore, the acceptance criteria and study design are focused on software functionality and equivalence, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Organize and manage databases for compatible Del Mar Reynolds monitoring products.	"CardioNavigator Plus has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." (Implies successful organization and management of databases)
Act as a "control panel" for compatible Del Mar Reynolds monitoring products.	"CardioNavigator Plus permits the user to operate the various devices in a manner identical to the way they were operated as individual products." (Implies successful control panel functionality)
Replace dedicated databases of individual monitoring devices with a common cardiology database.	"As noted before, these dedicated databases are replaced by the Cardio Navigator Plus database." (Implies successful database consolidation)
Store data collected from each patient in the section of the database dedicated to that patient.	"CardioNavigator Plus stores data collected from each patient in the section of the database dedicated to that patient." (Directly states this functionality)
Operate on a personal computer (PC) that meets specifications (single computer or server-workstation system).	"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... CardioNavigator Plus can be used on a single computer, but it has also been reconfigured to use as a server-workstation system." (Confirms compatibility and functionality in specified environments)
Equivalence in safety and efficacy to legally marketed predicate devices.	"CardioNavigator Plus is equivalent in safety and efficacy to the legally marketed predicate devices." (Direct statement from the conclusion)

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

Test Set Sample Size: Not explicitly stated. The document mentions "extensively validated," but no specific number of test cases, patient data sets, or usage scenarios is provided for the non-clinical validation.
Data Provenance: Not explicitly stated for the validation data. The product itself manages data from "Del Mar Reynolds monitoring products," which collect "cardiology patient data (ECG or blood pressure)." Whether the validation used synthetic data, existing patient data, or a mix is not specified. The study is prospective in the sense that the new software was developed and then "validated," rather than analyzing existing outcomes.

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

This information is not provided. Given that this is a software utility product for data management and control, rather than a diagnostic device, the concept of "expert ground truth" in the typical clinical sense (e.g., radiologists interpreting images) is not directly applicable. The validation would likely be against functional requirements and software specifications.

4. Adjudication Method for the Test Set

This information is not provided. As above, for a software utility, formal adjudication by clinical experts is unlikely to be the primary validation method. Validation would likely involve software testing methodologies, functional verification, and integration testing.

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

No, an MRMC comparative effectiveness study was not done.
The CardioNavigator Plus does not involve AI or analysis of medical data. It is a data management and control application. Therefore, there is no concept of human readers improving with or without AI assistance in the context of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone validation was done, but it's not an "algorithm" in the diagnostic sense. The document states: "CardioNavigator Plus has been extensively validated by itself and in conjunction with the associated Del Mar Reynolds Medical devices." This indicates that the software was tested independently for its functional requirements (standalone) and its interaction with other devices (without human-in-the-loop diagnostic performance being the metric).

7. The Type of Ground Truth Used

The type of "ground truth" used would be based on software specifications and functional requirements. For example, ground truth for database management would be correct storage, retrieval, and organization of data according to predefined rules. Ground truth for control panel functionality would be successful execution of commands to compatible devices. It is not clinical ground truth like pathology or outcomes data, as the device is not diagnostic.

8. The Sample Size for the Training Set

This information is not applicable and not provided.
CardioNavigator Plus is a rule-based software product for data management and control, not a machine learning or AI algorithm. Therefore, it does not have a "training set" in the context of machine learning.

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

This information is not applicable and not provided, as there is no training set for this type of software.

Summary

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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 201-727-1703 Fax 201-727-1708

(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.

Intended Use (ર)

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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.

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

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the caduceus symbol.

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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.

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

. '

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page of __

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).