UNITY IS PATIENT VIEWER

K020661 · General Electric Medical Systems Information Techn · MSX · May 24, 2002 · Cardiovascular

Device Facts

• Record ID: K020661
• Device Name: UNITY IS PATIENT VIEWER
• Applicant: General Electric Medical Systems Information Techn
• Product Code: MSX · Cardiovascular
• Decision Date: May 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Unity® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity® 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® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor. The Unity® 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 Story

Unity® IS Patient Viewer provides remote access to physiological data (waveforms, parameters, trends) from bedside monitors. Input: data from patient monitors via Unity® MC network. Transformation: server relays data to web browsers on standard PCs via hospital intranet. Output: near-real-time display of up to nine waveforms and parameter info. Used in hospitals by clinicians (nurses, physicians) on local/remote PCs. System acts as secondary view; does not display alarms or status messages. Clinicians must reference primary bedside monitor for care decisions. Benefits: enables remote patient data access for improved clinical workflow efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included risk analysis, requirements/design reviews, module verification, system integration testing, and final acceptance testing to ensure safety and performance equivalence.

Technological Characteristics

1U rack-mountable server platform. Interfaces with proprietary Unity® Network and hospital Intranet. Software-based server/client architecture for web-browser-based data visualization. Connectivity via standard hospital LAN/WAN. No specific material standards or advanced AI/ML algorithms described; functions as a network-based data relay system.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital or care facilities to provide remote viewing of physiological parameter data and graphical trends. Not for primary monitoring; must be used with bedside monitors under licensed healthcare practitioner supervision.

Regulatory Classification

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.

Predicate Devices

• GE Marquette Prism Information Server Applications (MPIS) (K001268)
• Quantitative Sentinel System (K993008)

Submission Summary (Full Text)

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MAY 2 4 2002

# Section 2 Summary and Certification

510(k) Summary of Safety and Effectiveness Date: February 28, 2002 Submitter: GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223 USA Contact Person: Karen Webb Sr. Regulatory Affairs Specialist GE Medical Systems Information Technologies Phone: [phone] Fax: [phone] Device: Trade Name: Unity® IS Patient Viewer Common/Usual Name: Computer, Information Network Server 21 CFR 870.2300 System, Network and Communication, Physiological Classification Names: Predicate Devices: K001268 GE Marquette Prism Information Server Applications (MPIS) K993008 Quantitative Sentinel System (Specific features) Device Description: The Unity® 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 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® 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® IS Patient Viewer, the clinician is instructed to

obtain the data from the primary bedside monitor.

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K020661
p 2/2

Intended Use: The Unity® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity® 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® IS Patient Viewer is NOT intended for primary monitoring but is to be used in coniunction with the bedside monitor.

> The Unity® 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).

Technology: The Unity® IS Patient Viewer system consists of a 1U Rack Mountable Server with server and client software packages.

> The two software pieces reside on the 1U Rack Mountable Server, which is a standard hardware server platform for hosting network applications. The hardware server is connected to two networks: Unity® Network and the hospital's Intranet. The Unity® Network is a currently marketed proprietary network connecting patient monitors. The hospital's Intranet refers to the existing Local Area Network (LAN) within the hospital that connects a number of personal computers (PCs).

#### Test Summary:

The Unity® 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® IS Patient Viewer:

- Risk Analysis ●
- Requirements Reviews .
- Desian 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® IS Patient Viewer are as safe, as effective, and perform as well as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 4 2002

Ms. Karen Webb Sr. Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 W. Tower Avenue Milwaukee, WI 53223

Re: K020661

Trade Name: Unity® IS Patient Viewer Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulation Number: 21 CFR 870.2300 Regulatory Class: Class II (two) Product Code: MSX Dated: February 28, 2002 Received: March 1, 2002

## Dear Ms. Webb:

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.

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

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## Page 2 – Ms. Karen Webb

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 (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 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 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 vours,

Afganmyna

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Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

Unknown; 510(k) filed on February 28, 2002 510(k) Number (if known):

Unity® IS Patient Viewer Device Name:

Indications for Use:

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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vascular & Respiratory Devic 4020666 0(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)