MODIFICATION TO UNITY NETWORK ID

K033672 · Ge Medical Systems Information Technologies · MWI · Dec 18, 2003 · Cardiovascular

Device Facts

• Record ID: K033672
• Device Name: MODIFICATION TO UNITY NETWORK ID
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 18, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.

Device Story

Unity Network ID acts as a data gateway/bridge; acquires digital patient data from eight serial ports of independent bedside devices; converts data to Unity Network protocols; transmits data over monitoring network to clinical information systems, central stations, or GE patient monitors. Used in clinical environments; operated by healthcare staff. Device does not perform monitoring or control functions; serves solely as a communication interface to facilitate data integration and management.

Clinical Evidence

No clinical data. Bench testing only, including module verification, system integration testing, performance testing, safety testing, and environmental testing.

Technological Characteristics

Data gateway system; features eight serial ports for data acquisition; converts non-GE device data to Unity Network protocols for transmission over monitoring networks. No patient monitoring or device control capabilities.

Indications for Use

Indicated for data collection and clinical information management via networks connected to independent bedside devices. Not intended for patient monitoring or controlling connected clinical devices.

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

• Unity Network ID (K021524)

Submission Summary (Full Text)

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DEC 1 8 2003

| Section 2 Summary | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary of Safety and Effectiveness | |
| Date: | November 21, 2003 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Diana M. Thorson<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: | Unity Network ID |
| Common/Usual Name: | 21 CFR 870.2300 Monitor, Physiological, Patient |
| Classification Name: | 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) |
| Predicate Device: | K021524 Unity Network ID |
| Device Description: | The Unity Network ID system communicates patient data from sources<br>other than GE Medical Systems Information Technologies equipment to<br>a clinical information system, central station, and/or GE Medical<br>Systems Information Technologies patient monitors.<br>The Unity Network ID acquires digital data from eight serial ports,<br>converts the data to Unity Network protocols, and transmits the data<br>over the monitoring network to a Unity Network device such as a patient<br>monitor, clinical information system or central station. |
| Intended Use: | The Unity Network ID is indicated for use in data collection and clinical<br>information management through networks with independent bedside<br>devices.<br>The Unity Network ID is not intended for monitoring purposes, nor is the<br>Unity Network ID intended to control any of the clinical devices<br>(independent bedside devices/ information systems) it is connected to. |
| Technology: | The Unity Network ID employs the same functional technology as the<br>predicate device. |

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Test Summary:

The Unity Network ID 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 system:

- 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 .
- The results of these measurements demonstrated that the Unity Conclusion: Network ID is as safe, as effective, and performs as well as the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2003

GE Medical Systems Information Technology c/o Ms. Diana M. Thorson Regulatory Affairs Specialist 8200 West Tower Ave. Milwaukee, WI 53223

Re: K033672

Trade Name: Unity Network ID Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: November 21, 2003 Received: November 24, 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 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 - Ms. Diana Thorson

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 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), please contact the Office of Compliance at [phone]. 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 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.

Ova Deenhu for

Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K033672 510(k) Number (if known):

510(k) filed on November 21, 2003

Device Name: Unity Network ID

Indications For Use:

The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to

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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)

Dma Deenlu

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