NETLINK/NETSCAN

K020213 · Rozinn Electronics, Inc. · DXH · Apr 5, 2002 · Cardiovascular

Device Facts

• Record ID: K020213
• Device Name: NETLINK/NETSCAN
• Applicant: Rozinn Electronics, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Apr 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

This transmission software will transfer ECG, ambulatory blood pressure, EKG, spirometry and any other data files from a remote site to a central station for analysis using modem, cable modem, ISDN lines, T1 lines, DSL, Internet or Intranet for analysis and send the analyzed data back to the remote site from the central site using the same transmission media.

Device Story

Netlink/Netscan is a software accessory for Northeast Monitoring's Holter for Windows Holter Scanner. It facilitates the transmission of cardiac data (ECG, ambulatory blood pressure, EKG, spirometry) from remote sites to a central analysis site. Data is transferred via modem, cable modem, ISDN, T1, DSL, Internet, or Intranet. The system uses encrypted, password-protected channels with automated data integrity checks and retransmission protocols to prevent loss or corruption. At the central site, the Holter for Windows software analyzes the data; results are then transmitted back to the remote site. Trained medical personnel at the remote site interpret the analyzed data to diagnose patients. The device enables remote clinical workflows, allowing for centralized analysis of patient data collected at disparate locations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and performance characteristics of the transmission system.

Technological Characteristics

Software-based transmission system operating on IBM PC AT compatible hardware (minimum 550MHz Pentium, 256MB RAM at remote site). Connectivity includes modem, cable modem, ISDN, T1, DSL, Internet, and Intranet. Data is encrypted and password-protected. Includes automated data integrity checks and retransmission logic.

Indications for Use

Indicated for the transmission of ECG, ambulatory blood pressure, EKG, spirometry, and other data files between remote sites and a central station for analysis by trained medical personnel to diagnose patients with cardiac rhythm patterns.

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

• PaceArt HomeTrak Plus EASI Event Recorder System (K982090)

Reference Devices

• Northeast Monitoring's Holter for Windows Holter Scanner (K930564)

Submission Summary (Full Text)

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K020213/ page 1 of 3

Image /page/0/Picture/1 description: The image shows the logo for ROZINN, with the tagline "The genius of simplicity." below it. To the right of the logo is a circular seal that says "QUALITY ASSURED FIRM" around the top and contains the text "ISO 9001" in the center. There is a checkmark below the text and the letters "DQS" below the checkmark.

510 (k) Summary

Submitter:

APR - 5 2002

| Mark Rosoff, President | |
|--------------------------|-----------------------------------------------------------------------------------|
| Rozinn Electronics, Inc. | |
| 71-22 Myrtle Avenue | |
| Telephone: | 718-386-5526 |
| Fax: | 718-366-4574 |
| E-mail: | [e-mail] |
| Contact: | Mark Rosoff |
| Date of Summary: | 11-07-01 |
| Name of Device: | Netlink/Netscan |
| Common Name: | ECG Transmission System |
| Classification Name: | Transmitters and receivers, Electrocardiograph telephone<br>(per 21 CFR 870.2920) |

Substantial Equivalence claimed to legally marketed device: PaceArt HomeTrak Plus EASI Event Recorder System- 510(k) K982090

## Description of Device:

Netlink/Netscan is an accessory to Northeast Monitoring's Holter for Windows Holter Scanner (K930564) that sends recorded cardiac ECG data from remote sites to a central site using standard TCP/IP transfer protocols and where the central site is equipped with Northeast Monitoring's Holter for Windows Holter Scanner for analysis. equipped Monitoring's Holter for Windows Holter Scanner software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data which is analyzed and provides reports on eforms and patterns of consecutive waveforms. The analysis is then returned to the remote site and interpreted by trained medical personnel to diagnose patients with cardiac rhythm patterns.

Netlink/Netscan is an accessory that provides a means to transmit data to and from Northeast Monitoring's Holter for Windows Holter Scanning System . Data can be transferred via modem, cable modems, ISDN lines, T1 lines, DSL, Internet or Intranet. All transferred data is encrypted and is only accessed through a password controlled by the remote and central sites. Netlink/Netscan software contains data checks to prevent the loss or corruption of data during transmission. Nelink/Netscan will resend data if transmission is interrupted.

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K020213/Page
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# Intended use of Device:

This transmission software will transfer ECG, ambulatory blood pressure, EKG, spirometry and any other data files from a remote site to a central station for analysis using modem, cable modem, ISDN lines, T1 lines, DSL, Internet or Intranet for analysis and send the analyzed data back to the remote site from the central site using the same transmission media.

Comparison of Technology characteristics compared to predicate device:

| Specifications | Predicate Device<br>Paceart HomeTrak Plus<br>EASI Event Recorder<br>System | New Device<br>Netlink/Netscan<br>Central Site |
|----------------|----------------------------------------------------------------------------|-----------------------------------------------|
| Type | IBM PC AT Compatible | IBM PC AT Compatible |
| CPU | 166 Mhz Pentium or greater | 550MHz Pentium or greater |
| RAM | 2 Mbytes Minimum | 2 Mbytes Minimum |
| Hard disk | 2.1 Gbytes Minimum | 2.1 Gbytes Minimum |
| Display | SVGA | SVGA |
| Modem | 28.8K with dedicated line | Yes |
| Cable Modem | No | Yes |
| Internet | No | Yes |
| ISDN Line | No | Yes |
| T1 Line | No | Yes |
| DSL | No | Yes |
| Specifications | Predicate Device<br>Paceart HomeTrak Plus<br>EASI Event Recorder<br>System | New Device<br>Netlink/Netscan<br>Remote Site |
| Type | IBM PC AT Compatible | IBM PC AT Compatible |
| CPU | 166 Mhz Pentium or greater | 550 MHz Pentium or greater |
| RAM | 32 Mbytes Minimum | 256 Mbytes Minimum |
| Hard disk | 2.1 Gbytes Minimum | 2.1 Gbytes Minimum |
| Display | SVGA | SVGA |
| Modem | 28.8K with dedicated line | Yes |
| Modem Cable | No | Yes |
| Internet | No | Yes |
| ISDN Line | No | Yes |
| T1 Line | No | Yes |
| DSL | No | Yes |
| Network Card | No | Yes |

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Conclusion:

The only difference between the Netlink/Netscan and the Paceart HomeTrak Plus EASI Event Recorder System is the use of transmission systems used. The Netlink/Netscan will transmit data using Internet, ISDN Lines, DSL, T1 Lines, Cable Modem and Modem whereas the PaceArt HomeTrak Plus EASI Event Recorder System only transmits data using a modem. In summary the performance between the two systems were nearly identical and supports the claim that they are substantially equivalent.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 5 2002

Mr. Mark Rosoff President Rozinn Electronics, Inc. 71-22 Myrtle Avenue Glendale, NY 11385-7254

Re: K020213

Trade Name: Netlink/Netscan Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DXH Dated: January 11, 2002 Received: January 22, 2002

Dear Mr. Rosoff:

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. Mark Rosoff

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 corply 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 Of It Fat 607), and may (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 premated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

ch

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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# STATEMENT OF INDICATIONS FOR USE

K020213 510(K) Number (if known):

Device Name: Netlink/Netscan

Indications for Use:

The Netlink/Netscan is a transmission software which will transmit ECG, ambulatory blood pressure, EKG, spirometry, and any other data files from a remote site to a central station for analysis using a modem, cable modem, ISDN line, T1 lines, DSL, Internet or Intranet and send the analyzed data back to the remote site from the central * site using the same transmission media.

Division of Cardiovasc
510(k) Number K020213

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Image /page/5/Picture/8 description: The image shows the word "ROZINN" in a bold, sans-serif font. There are two horizontal lines, one above and one below the word. The lines appear to be part of a logo or branding element. The letters are all capitalized and evenly spaced.