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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) summary for the Netlink/Netscan device, an ECG Transmission System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use. The document does not contain information about specific acceptance criteria, comprehensive device performance studies, sample sizes for testing, expert adjudication, or MRMC studies. It mainly compares the technical specifications and transmission methods of the new device with a predicate device.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states, "In summary the performance between the two systems were nearly identical and supports the claim that they are substantially equivalent," but does not provide specific performance metrics or acceptance criteria that were met. The comparison focuses on hardware specifications and transmission modalities.

Acceptance Criteria	Reported Device Performance
Not specified	"Nearly identical" performance to predicate device for data transmission capacity and method.

2. Sample Size Used for the Test Set and Data Provenance

Not available. The document does not describe any specific test set or data provenance for a performance study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not available. The document does not describe the establishment of ground truth by experts for a test set.

4. Adjudication Method for the Test Set

Not available. The document does not describe any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention an MRMC study or any comparison of human reader performance with or without AI assistance. This device is a data transmission system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. The device is a transmission system, not an algorithm providing diagnostic outputs. The "analysis" of ECG data is performed by "Northeast Monitoring's Holter for Windows Holter Scanner software," and then "interpreted by trained medical personnel." The Netlink/Netscan facilitates the transmission of this data.

7. The Type of Ground Truth Used

Not applicable in the context of a diagnostic algorithm. The "ground truth" implicitly refers to the accuracy and integrity of data transmission, not diagnostic accuracy based on expert consensus, pathology, or outcomes data, as this device does not perform diagnosis. The document states that the software "contains data checks to prevent the loss or corruption of data during transmission," implying that the "ground truth" for its function would be successful, uncorrupted data transfer.

8. The Sample Size for the Training Set

Not applicable. The device is a data transmission system, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, the device is not an AI/ML model requiring a training set.

Summary

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K020213/ page 1 of 3

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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:	mark@rozinn.com
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(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:

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K020213/Page
2 of 3

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 DevicePaceart HomeTrak PlusEASI Event RecorderSystem	New DeviceNetlink/NetscanCentral 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 DevicePaceart HomeTrak PlusEASI Event RecorderSystem	New DeviceNetlink/NetscanRemote 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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K020213/$\frac{page}{3 of 3}$

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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:

Division of Cardiovasc
510(k) Number K020213

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Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).