TM2000, MODEL 1

K013879 · Card Guard Scientific Survival , Ltd. · DXH · Feb 1, 2002 · Cardiovascular

Device Facts

• Record ID: K013879
• Device Name: TM2000, MODEL 1
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Telemedicine 2000 (TM2000) Transtelephonic Receiving Center is a software system designed and intended for supporting a remote (transtelephonic) monitoring ECG, Spirometric and Fetal/Maternal patient parameters. The enhanced TM2000 enables receiving, storing, displaying, measuring, updating, printing and re-transmitting of patient ECG, Spirometric and Fetal/Maternal parameters and other patient related data, (such as demographics, doctors, medical history and status, diagnoses, etc.), and business information (e.g. billing, inventory sales etc.).

Device Story

TM2000 is a software-based receiving center for remote patient monitoring. It receives, stores, displays, measures, and re-transmits ECG, spirometric, and fetal/maternal physiological signals transmitted via telephone or web. The system manages patient demographics, medical history, and administrative data (billing/inventory). Operated by clinical staff at a receiving facility, the software runs on MS Windows, utilizing a GUI for data visualization and report generation. It provides clinicians with a centralized platform to review transmitted data, facilitating clinical decision-making through remote monitoring. The system includes security features like discretionary access control to protect patient data. It benefits patients by enabling remote access to specialized monitoring services without requiring physical presence at a clinic.

Clinical Evidence

Bench testing only. The system underwent rigorous design evaluation, verification, and validation testing to ensure compliance with design specifications. System safety and risk analysis were performed to identify potential failures. No clinical trial data was required for this 510(k) submission.

Technological Characteristics

Software system running on MS Windows OS. Utilizes JVM and C/C++ native methods with Windows API functions. Features include database management (up to 2GB, 10-40k transmissions), GUI for signal/data display, web transmission capability, and report generation. Security includes discretionary access control. Moderate level of concern software.

Indications for Use

Indicated for the remote (transtelephonic) monitoring of ECG, Spirometric, and Fetal/Maternal parameters in patients requiring such physiological data transmission.

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

• Telemedicine 2000, the Transtelephonic Receiving Center (K992164)

Submission Summary (Full Text)

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| CARD GUARD<br>Scientific Survival LTD | 510(k) Summary of Safety and Effectiveness<br>TM2000 Transtelephonic Receiving Center | | K013379<br>P.1/2 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|------------------|
| Submitter: | Card Guard Scientific Survival Ltd.,<br>2 Pekeris St. P.O.B. 527<br>Rehovot 76100, Israel<br>Tel: [phone] | | FEB 01 2002 |
| Contact Person: | Fax: [phone]<br>Alex Gonorovsky,<br>Deputy Chief Engineer, Regulatory Affairs<br>Tel: [phone]<br>E-mail: [e-mail] | | |
| Date Prepared: | August 12, 2001 | | |

- 1. Definition and Intended Use
The Telemedicine 2000 (TM2000) Transtelephonic Receiving Center is a software system designed and intended for supporting a remote (transtelephonic) monitoring ECG, Spirometric and Fetal/Maternal patient parameters.

The enhanced TM2000 enables receiving, storing, displaying, measuring, updating, printing and re-transmitting of patient ECG, Spirometric and Fetal/Maternal parameters and other patient related data, (such as demographics, doctors, medical history and status, diagnoses, etc.), and business information (e.g. billing, inventory sales etc.).

### 2. Device Class

The TM2000 Transtelephonic Receiving Center system is classified as Class II medical device (21 C.F.R. Par. 870.2920 (1992)).

## 3. Applicable Requlatory Documents and Card Guard Procedures

No performance standards have been developed under Section 514 of the Federal Food, Drug and Cosmetic Act for telephone ECG and Spirometric transmitter devices.

The complete list of the Applicable Documents referenced and/or incorporated in this project is provided in the FDA submission package: Chapter 19, Applicable Normative Documents: Standards, Regulations, Guidances, Procedures; Publications

Chapter 19 includes the following sections:

- Applicable FDA Documents .
- American National Standards Institute (ANSI), Association for the Advancement . of Medical Instrumentation (AAMI)
- International Electrotechnical Commission (IEC/CEI), International Organization ● for Standardization (ISO), European Norm (EN)
- Code of Federal Regulations .
- International Special Committee On Radio Interference (CISPR) .
- Institute of Electrical and Electronics Engineers (IEEE) ●
- Card Guard Ltd: Applicable Procedures .
- Card Guard Ltd: Product Definitive Reference .
- Articles, Publications .

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Image /page/1/Picture/0 description: The image shows the words "CARD GUARD" in bold, black font. Underneath this text is the phrase "Scientific Survival LTD" in a smaller, black font. There is a horizontal line separating the two phrases. To the right of the text is a jagged, vertical line.

# 510(k) Summary of Safety and Effectiveness TM2000 Transtelephonic Receiving Center

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- Operational Characteristics, Features and Functions ধ
- 1. Runs on any MS Windows operating system
- Maximum database file size of 2 GB, 2. Storage of up to 10 - 40 thousand transmissions (depending on transmitter type)
- 3. Accessing and updating the receiving center DB. Manual entry of patient and physician detail
- 4. Receiving and processing patients' transmitted signals and medical data
- 5. Graphic representation of ECG, Spirometric and FM signals
- 6. Intuitive, user friendly HMI
- 7. Availability for signal/data transmission over Web
- 8. Localization
- 9. Reports generation
- 10. Reports previewing and printing
- 11. Manageable security, fail-safe protection against unauthorized access. Discretionary access control (restrictions based on privileges)
- ട്. User Interface

The TM2000 Graphic User Interface (GUI) features pull down menus and dialog boxes for representation and updating of data. Generation of GUI and implementation of the related DB connectivity mechanism shall utilize JVM and the C/C++ native methods in conjunction with the Windows API functions.

### Substantial Equivalence 6.

Card Guard hereby claims that the TM2000 is substantially equivalent to Telemedicine 2000, the Transtelephonic Receiving Center, K992164

The proof of substantial equivalence in all that concerns the intended use, principles of operation, features and technological characteristics is provided in Chapter 7. Substantial Equivalence to Cleared Devices.

### Design Controls and Hazard Analysis 7.

The Card Guard's product design procedure, and QA and QC policy, formalize the design and production process and assure that all the respective requirements are met. In the framework of the Design Controls the testing was conducted to verify the system compliance with all its design specifications.

The device Level of Concern criteria were evaluated and the system was determined to be a moderate level of concern system.

The rigorous design evaluation and the System Safety and Risk analysis expose potential failures or possible system flaws which could directly or indirectly effect the patient.

#### Conclusions 8.

The system constitutes a safe and reliable means for receiving, storing, analyzing, updating, printing and re-transmitting of patient ECG and Spirometric parameters and other patient related data.

Its operation present no adverse health effect or safety risks to patients when used as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the eagle's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Mr. Alex Gonorovsky Deputy Chief Engineer, Regulatory Affairs Card Guard Scientific Survival, Ltd. 2 Pekeris Street Rehovot ISRAEL

Re: K013879

Trade Name: TM2000 Telemedicine Receiving Center Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DXH Dated: November 20, 2001 Received: November 23, 2001

Dear Mr. Gonorovsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conniner of they 20, 1978, is accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains 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 If your device is classinos controls. Existing major regulations affecting your device can may or sations 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 I loase of actived that I Dr. Pression that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odolar butther and regirements, 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 rordly in and quand) 25thons (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) I ma lotet watification. The FDA finding of substantial equivalence of your device to a legally premaince noticated wice 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 and 11 you dellionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 01 ) 594-4646. Additionally, for questions on the promotion and advertising of Compliance please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Nilocrania on your responsibilities under the Act may be obtained from the Other general mironmances turers, 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,

H

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Card Guard Scientific Survival LTD. The logo is in black and white and features the text "CARD GUARD" in bold letters, with "Scientific Survival LTD" written in a smaller font underneath. To the right of the text is a graphic that resembles an electrocardiogram (ECG) waveform.

The TM2000 Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of Electrocardiography (ECG), Spirometric and Fetal/Maternal parameters of patients.

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)

Over-The-Counter Use OR

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013879