PMP4 MEDICAL WEB CENTER

K050940 · Card Guard Scientific Survival , Ltd. · DXH · Jul 1, 2005 · Cardiovascular

Device Facts

• Record ID: K050940
• Device Name: PMP4 MEDICAL WEB CENTER
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The PMP4 Medical Web Center is a Software application intended for supporting remote monitoring of Electrocardiographic (ECG), Spirometric, Fetal/Maternal, Blood Pressure, Heart Rate, Blood Glucose, Blood Oxygen Saturation, Body Weight and optionally other patients' vital signs and parameters. The data is received from transducers/monitors, which are external to the system.

Device Story

PMP4 Medical Web Center is a web-based communication system for remote patient monitoring. It receives health data wirelessly from external monitors (ECG, spirometer, pulse oximeter, blood pressure, blood glucose, weight scale). Data is transmitted to a secure web-based center accessible via internet browser. Physicians use the system to store, display, and manage patient medical files, diagnoses, and health trends. Patients use the system to view their own health measurements and educational content. The system notifies healthcare providers of new data. It aims to improve patient compliance, disease management, and reduce hospitalizations. Operated by patients and healthcare providers in various settings (home, clinic).

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Web-based software application accessed via internet browser. Integrates with external medical monitors via wireless transmission. Supports data management for ECG, spirometry, blood pressure, pulse rate, glucometry, and other vital signs. System architecture includes a secure patient database and personal web pages for data storage and display.

Indications for Use

Indicated for remote monitoring of vital signs and health parameters including ECG, spirometry, fetal/maternal data, blood pressure, heart rate, blood glucose, oxygen saturation, and body weight in patients requiring remote health management.

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

• TM2005 Receiving Center (K024365)

Submission Summary (Full Text)

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Image /page/0/Figure/1 description: The image shows the logo for Card Guard. The logo features the words "CARD GUARD" in bold, black letters. Below the words is the text "Scientific Survival LTD." The logo also includes a stylized electrocardiogram (ECG) waveform, which is a visual representation of the electrical activity of the heart.

# PMP4 Medical Web Center Special 510(k) Summary

## 1. System Definition

The Card Guard® PMP4 Medical Web Center is a medical communication system using the latest cellular technologies, a mobile device (e.g. PDA, Cellular Phone), and personal medical monitors. It allows the patient to monitor his health and interact with the physician from anywhere and at anytime. As a web-based application, all the data is accessed through a common internet browser.

The PMP4 Medical Web Center provides round-the-clock monitoring services from any location for healthcare providers and patients. The Center generates and manages electronic medical files for each patient who can be accessed from any handheld or PC browser. Patients receive a secure personal web page to send, view and store their health measurements, physician diagnosis, and disease-specific health trends. Physicians receive a secure patient database to host patient's medical files and test results. The Center also features educational content and health tips specific to the subscribers' health condition.

The Center enables receiving, storing, displaying, updating, printing and forwarding of patient health and other patient related data, (such as demographics, doctors, medical history, diagnoses, etc.).

Each user has a unique access to the Center. The system enables the administrator to add users, set user permissions and link between users.

After recording a test on PMP4 monitors, the measurement can be sent wirelessly to the PMP4 Center, and the healthcare provider is notified of new patient data. The PMP system can help patients improve compliance and clinical outcomes, improve disease management and may reduce unnecessary hospitalizations, and emergency room visits.

The PMP4 medical line of products include a 1/12-lead ECG event monitor, Spirometer, Pulse Oximeter, and monitors for measuring Blood Pressure, and Blood Glucose. Other monitors, such as Body Fat, Heart Rate, Body Temperature, and Weight Scale are proposed as future options.

#### 2. Name: Classification and Trade

PMP4 Medical Web Center Trade name: PMP4 Center Classification name: Class II medical devices (21 C.F.R. Par. 870.2920 (1992)

### 3. Substantial Equivalence

The basis PMP4 Medical Web Center is substantially equivalent the TM2005 Receiving Center K024365: it has similar intended use and main principles of operation. The main difference between the systems is that in PMP Center is designed to monitor spirometric, blood pressure and pulse rate, glucometric, and cardiac data (ECG), while TM2005 is a cardiac center only.

- 4. Proposed Labeling
- The PMP4 Medical Web Center is a medical communication system used to 1 . monitor patient's health parameters.
- The PMP4 Center is a web-based application used to access data through an 2. internet browser.
- The PMP4 Center enables receiving, storing, displaying, updating, printing and 3. forwarding of patient health and other related data, (e.g. demographics, doctors, medical history, diagnoses, etc.).

This document contains proprietary information of CARD GUARD Scientific Survival Ltd.

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Image /page/1/Picture/1 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 often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 - 2005

Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Manager, Regulatory Affairs 2 Pekeris St. P.O.B. 527 Rehovot 76100 Israel

Re: K050940

Trade Name: PMP4 Medical Web Center Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: June 9, 2005 Received: June 13, 2005

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.

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Page 2 - Mr. Alex Gonorovsky

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 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.

Sincerely yours,

Donna R. Wachner

Image /page/2/Picture/5 description: The image shows a hand-drawn symbol that resembles a stylized mountain range or a waveform. It consists of two peaks connected by a curved line at the bottom. The symbol is simple and lacks shading or color, giving it a minimalist appearance.

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

K050940/s

The PMP4 Medical Web Center is a Software application intended for supporting remote monitoring of Electrocardiographic (ECG), Spirometric, Fetal/Maternal, Blood Pressure, Heart Rate, Blood Glucose, Blood Oxygen Saturation, Body Weight and optionally other patients' vital signs and parameters.

The data is received from transducers/monitors, which are external to the system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1

una R. hchner

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number_K050940