(73 days)
No
The description focuses solely on data transmission and basic data integrity checks, with the analysis being performed by separate software (Northeast Monitoring's Holter for Windows Holter Scanner) and interpreted by trained medical personnel. There is no mention of AI or ML in the transmission software itself.
No.
The device is a transmission software that sends data from a remote site to a central station for analysis and returns the analyzed data. It is explicitly described as an "accessory" to a Holter scanner and does not directly provide therapy.
No
This device is described as "transmission software" and an "accessory" that "sends recorded cardiac ECG data ... to a central site for analysis." It facilitates the transfer of data, but the analysis and diagnosis occur with separate systems (the Holter Scanner software and trained medical personnel), not by the device itself.
Yes
The device description explicitly states "Netlink/Netscan software" and describes its function as transmitting data, acting as an accessory to existing software and hardware systems (Holter for Windows Holter Scanner). It does not appear to include any new or modified hardware components.
Based on the provided information, the Netlink/Netscan device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Netlink/Netscan's Function: The Netlink/Netscan is described as transmission software. Its primary function is to transmit existing data files (ECG, blood pressure, spirometry, etc.) from one location to another for analysis by a separate device (Northeast Monitoring's Holter for Windows Holter Scanner). It does not collect, prepare, or examine specimens from the human body.
- Accessory to a Non-IVD: It is explicitly stated as an "accessory" to Northeast Monitoring's Holter for Windows Holter Scanner (K930564). While the scanner analyzes physiological data, it is not an IVD itself as it analyzes electrical signals from the body, not specimens.
- Data Transmission, Not Analysis: The software's role is solely data transfer. The analysis and interpretation are performed by the Holter Scanner software and trained medical personnel, respectively.
Therefore, the Netlink/Netscan falls outside the scope of an In Vitro Diagnostic device. It is a data transmission tool for medical information.
N/A
Intended Use / 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.
Product codes
DXH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel / remote site to a central station
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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:
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
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 Device
Paceart HomeTrak Plus
EASI Event Recorder
System | New Device
Netlink/Netscan
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
Paceart HomeTrak Plus
EASI Event Recorder
System | New Device
Netlink/Netscan
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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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,
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
5
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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