PMP4 APPLICATION

K061428 · Card Guard Scientific Survival , Ltd. · MSX · Oct 16, 2006 · Cardiovascular

Device Facts

• Record ID: K061428
• Device Name: PMP4 APPLICATION
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: MSX · Cardiovascular
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The PMP4 Application is intended for: a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data

Device Story

PMP4 Application facilitates remote monitoring of patient vital signs. Patients use the system to acquire, display, and transmit physiological data to a web-based call center. Medical professionals access this data for analysis, follow-up, and clinical response. The system acts as a communication bridge between patient and physician, enabling remote medical testing and data-driven clinical decision-making. It supports both patient self-use for data transmission and physician use for review and intervention. The device aims to improve patient access to care and facilitate timely clinical responses to vital sign trends.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use characteristics.

Technological Characteristics

Network and communication physiological system; web-based architecture for data transmission; software-based interface for vital sign display and analysis.

Indications for Use

Indicated for patients requiring remote acquisition, display, and transmission of vital signs to medical professionals for analysis, and for physicians conducting medical testing, follow-up, and response to transmitted patient vital sign data.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 2006

Card Guard Scientific Survival LTD c/o Alex Gonorovsky 2 Perkins St. Rehovot, TX 76100

Re: K061428

Trade/Device Name: PMP4 Application Regulation Number: 21 CFR 870.2300 Regulation Name: Network and Communication Physiological System Regulatory Class: Class II Product Code: MSX Dated: August 10, 2006 Received: September 6, 2006

Dear Mr. Gonorovsky:

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 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 such additional controls. Existing major regulations 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.

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

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## Page 2 - Mr. Gonorovsky

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 begin 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/industry/support/index.html.

Sincerely yours.

Bhimmar fr

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 and Intended Use PMP4 Application

510(k) Number (if known):

K061428 pg lofl

The PMP4 Application Device Name:

Indication for Use:

The PMP4 Application is intended for:

a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response

Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and b) response to patient's transmitted data

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✔ (Per 21 CFR 801.109) (Optional Format 1-2-96)

OR

Over-The-Counter Use V

B. Zimmerman