SENTINEL

K062397 · Del Mar Reynolds Medical, Ltd. · DXH · Jan 25, 2007 · Cardiovascular

Device Facts

• Record ID: K062397
• Device Name: SENTINEL
• Applicant: Del Mar Reynolds Medical, Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Sentinel, 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

Sentinel is a software-based central database and control panel for Del Mar Reynolds Medical cardiology monitoring devices. It replaces individual dedicated software programs previously used for device configuration, data downloading, and report generation. The software organizes and manages patient data (ECG or blood pressure) collected from compatible devices into a common database. It functions as a control panel, allowing users to operate connected devices via a familiar interface identical to the original dedicated software. Sentinel does not perform ECG analysis; it can launch the Pathfinder Holter Analysis program if installed on the same PC, but maintains no other control links. It operates on a PC in either standalone or networked environments. Healthcare providers use the output to manage patient records and configure monitoring equipment, facilitating centralized data access and streamlined clinical workflows.

Clinical Evidence

No clinical data. Bench testing only. The device was extensively validated through non-clinical testing to ensure performance and safety in conjunction with associated Del Mar Reynolds Medical devices.

Technological Characteristics

Software-based database management and control system. Operates on standard PCs in standalone or networked configurations. No specific hardware materials or energy sources. Software-based interface mimics legacy device-specific control panels. Connectivity via local network or standalone PC. No automated analysis algorithms; relies on external software (e.g., Pathfinder) for clinical analysis.

Indications for Use

Indicated for users of Del Mar Reynolds Medical monitoring products who wish to consolidate databases and manage device configurations.

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

• DelMar Reynolds CardioNavigator Plus (K051960)

Submission Summary (Full Text)

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K062397

Q 1/2

Del Mar Reynolds Medical Ltd. Special 510(k) Submission Sentinel 510(k) Summary

(1) Submitter Information

Name: DelMar Reynolds Medical Ltd.

Address:

1-2 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]

Date Prepared: July 27, 2006

(2) Name of Device

Trade Name: Sentinel Common Name: Central Data Base for Cardiology Devices Classification name: Computers and Software, Medical

(3) Equivalent legally-marketed devices.

1. DelMar Reynolds CardioNavigator Plus, K051960

(4) Description

Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Reynolds Monitoring program finended to organize and manage the databases tor
compatible Reynolds Monitoring products and also to act as a "control panel" for thes

JAN 2 5 2007

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that formerly was used with these devices has been transferred to sections of Sentinel. The program itself can be >plied 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 data bases are replaced by the Sentinel database.

Sentinel 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 data base, Sentinel 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 iron associated with the device. The user then sees the opening screen for the operation of that device, even all socceeding screens, as they were seen when the device was used with its dedicated program.

Sentinel has no capacity for analyzing electrocardiograms. When Sentinel is used with the Pathfinder Holter Analysis program, the Pathfinder program is loaded into the same computer, and Pathfinder cannove alled by Sentinel, but there are no other control links

Sentinel can be used on a personal computer (PC) that meets specifications established by Del Mar Reynolds Medical. Sentinel 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.

Sentinel will work on a single computer, but it has been re-configured to be also used in a network

、) Intended Use

Sentinel, a software product, is a computer program intended to organize and manage the databases for compatible Del Mar Reynolds Medical Monitoring products and minutes and manyales for these products. It is indicated when a user wishes to consolidate the databases of his Del Mar Reynolds Medical products.

(6) Performance Data

(a) Non-clinical tests

Sentinel 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 Sentinel uses the same technology as the predicate device.

(c) Conclusions

Sentinel is equivalent in safety and efficacy to the legally-marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2007

Medsys, Inc. c/o Dr. George Myers Official Correspondent 377 Route 17 S Hasbrouck Heights, NJ 07604

Re: K062397

Trade Name: Sentinel Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II (two) Product Code: DXH Dated: January 5, 2007 Received: January 8, 2007

Dear Mr. Myers:

This letter corrects our substantially equivalent letter of January 25, 2006.

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 (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 misbranding and adulteration.

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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In

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Page 2 - Mr. Myers

addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 contact the Office 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 Manufacturers, 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,

B. Armimotor for

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

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## Indications for Use

K062397 510(k) Number (if known):

Device Name: Sentinel

Indications for Use:

Sentinel, 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(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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