K Number
K032346
Device Name
UNITY NETWORK IS PATIENT VIEWER
Date Cleared
2003-08-05

(6 days)

Product Code
Regulation Number
870.2300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Unity Network® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor. The Unity Network® IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).
Device Description
The Unity Network® IS Patient Viewer provides remote access to waveform, parameter data and trend data at a Web browser on a standard personal computer. The server resides on the hospital's intranet and remote access is gained through secured access to the hospital's intranet. The data relayed from the patient monitors over the Unity® MC network includes patient name, unit and bed name, parameter data, and waveform data monitored by the bedside monitors. The user can view up to nine waveforms from the Unity® MC network as well as the parameter information in near real-time. Neither alarm messages nor parameter status messages are displayed. The Unity Network® IS Patient Viewer system provides a secondary view of patient information, and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions. In the event that data is not available via the Unity Network® IS Patient Viewer, the clinician is instructed to obtain the data from the primary bedside monitor.
More Information

Not Found

No
The document describes a system for remotely viewing physiological data from bedside monitors, focusing on data transmission and display, with no mention of AI/ML algorithms for analysis or interpretation.

No.
The device provides a remote view of physiological parameter data and is explicitly stated as NOT intended for primary monitoring and NOT a patient monitoring device. It only displays data and does not provide any therapeutic intervention.

No

Explanation: The device provides a remote view of physiological parameter data from bedside monitors and is explicitly stated as NOT being intended for primary monitoring or as a patient monitoring device. It functions as a data viewer, not for diagnosing conditions.

Yes

The device description explicitly states it provides remote access to data via a Web browser on a standard personal computer and the server resides on the hospital's intranet. This indicates it is a software application running on existing hardware infrastructure, without including dedicated hardware components as part of the device itself.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Function: The Unity Network® IS Patient Viewer provides a remote view of physiological parameter data and waveform data collected directly from bedside patient monitors. This data is generated by devices monitoring the patient's body in real-time, not from analyzing samples taken from the body.
  • Intended Use: The intended use clearly states it's for viewing physiological data on patients, not for performing diagnostic tests on samples.
  • Device Description: The description reinforces that it relays data from patient monitors, including parameter and waveform data.

The device is a patient monitoring accessory or information system, not an IVD.

N/A

Intended Use / Indications for Use

The Unity Network® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor.

The Unity Network® IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

Product codes

MSX

Device Description

The Unity Network® IS Patient Viewer provides remote access to waveform, parameter data and trend data at a Web browser on a standard personal computer. The server resides on the hospital's intranet and remote access is gained through secured access to the hospital's intranet.

The data relayed from the patient monitors over the Unity® MC network includes patient name, unit and bed name, parameter data, and waveform data monitored by the bedside monitors. The user can view up to nine waveforms from the Unity® MC network as well as the parameter information in near real-time. Neither alarm messages nor parameter status messages are displayed.

The Unity Network® IS Patient Viewer system provides a secondary view of patient information, and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions. In the event that data is not available via the Unity Network® IS Patient Viewer, the clinician is instructed to obtain the data from the primary bedside monitor.

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

adult, pediatric and neonatal patients

Intended User / Care Setting

licensed healthcare practitioner. The Unity Network® IS Patient Viewer is intended for use ... within a hospital or facility providing patient care.

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

The Unity Network® IS Patient Viewer complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network® IS Patient Viewer:

  • Risk Analysis .
  • Requirements Reviews .
  • Design Reviews
  • Testing on unit level (Module verification) .
  • Integration testing (System verification) .
  • Final acceptance testing (Validation) ●
  • Performance testing
  • Safety testing .
  • Environmental testing .

Key Metrics

Not Found

Predicate Device(s)

K020661 Unity Network® IS Patient Viewer

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).

0

AUG - 6 2003

Section 2 Summary and Certification

510(k) Summary of Safety and Effectiveness

Date:July 29, 2003
Submitter:GE Medical Systems Information Technologies
8200 West Tower Avenue
Milwaukee, WI 53223 USA
Contact Person:Diana M. Thorson
Regulatory Affairs Specialist
GE Medical Systems Information Technologies
Phone: (714) 247-4135
Fax: (414) 918-8114
Device: Trade Name:Unity Network® IS Patient Viewer
Common/Usual Name:Computer, Information Network Server
Classification Names:21 CFR 870.2300 System, Network and Communication, Physiological
Predicate Devices:K020661 Unity Network® IS Patient Viewer
Device Description:The Unity Network® IS Patient Viewer provides remote access to
waveform, parameter data and trend data at a Web browser on a
standard personal computer. The server resides on the hospital's
intranet and remote access is gained through secured access to the
hospital's intranet.

The data relayed from the patient monitors over the Unity® MC network
includes patient name, unit and bed name, parameter data, and
waveform data monitored by the bedside monitors. The user can view
up to nine waveforms from the Unity® MC network as well as the
parameter information in near real-time. Neither alarm messages nor
parameter status messages are displayed.

The Unity Network® IS Patient Viewer system provides a secondary
view of patient information, and is NOT a patient monitoring device.
The clinician is instructed to always reference the primary bedside
monitor before making any patient care decisions. In the event that
data is not available via the Unity Network® IS Patient Viewer, the
clinician is instructed to obtain the data from the primary bedside
monitor. |

1

Intended Use: The Unity Network® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor. -

The Unity Network® IS Patient Viewer is intended to provide near-realtime physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

The Unity Network® IS Patient Viewer system employs the same Technology: functional technology as the predicate device. Changes made reflect the recent advancements in wireless technology, offering improved performance and mobility.

Test Summary:

The Unity Network® IS Patient Viewer complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network® IS Patient Viewer:

  • Risk Analysis .
  • Requirements Reviews .
  • Design Reviews
  • Testing on unit level (Module verification) .
  • Integration testing (System verification) .
  • Final acceptance testing (Validation) ●
  • Performance testing
  • Safety testing .
  • Environmental testing .

Conclusion:

The results of these measurements demonstrated that the Unity Network® IS Patient Viewer is as safe, as effective, and perform as well as the predicate device.

2

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is rendered in black and white.

AUG - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies Ms. Diane M. Thorson Corporate Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K032346

Trade Name: Unity Network® IS Patient Viewer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: July 29, 2003 Received: July 30, 2003

Dear Ms. Thorson:

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 10 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. Iisting 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.

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

3

Page 2 - Ms. Diane M. Thorson

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 (OS) 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 (301) 594-4646. 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 (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.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Page 1 of 1

510(k) Number (if known):

510(k) filed on July 29, 2003

Device Name:

Unity Network® IS Patient Viewer

Indications for Use:

The Unity Network® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor.

The Unity Network® IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

(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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Nole Te

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number