MODIFICATION TO UNITY NETWORK ID

K040559 · Ge Medical Systems Information Technologies · MWI · Jun 4, 2004 · Cardiovascular

Device Facts

• Record ID: K040559
• Device Name: MODIFICATION TO UNITY NETWORK ID
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 4, 2004
• 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 network gateway/interface; acquires digital data from eight serial ports; converts data to Unity Network protocols; transmits data over monitoring network to patient monitors, clinical information systems, or central stations. Used in clinical environments; operated by healthcare staff. Device facilitates data integration from non-GE equipment into GE clinical information systems. Does not perform monitoring or control functions; serves as a communication bridge to support clinical information management.

Clinical Evidence

Bench testing only. No clinical data provided. System verification and validation included risk analysis, requirements/design reviews, module/integration testing, and performance/safety/environmental testing.

Technological Characteristics

Network gateway/interface; 8 serial ports; converts non-GE digital data to Unity Network protocols; networked connectivity; software-based data conversion.

Indications for Use

Indicated for data collection and clinical information management via networks connected to independent bedside devices. Not for patient monitoring or control of 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 (K033672)

Submission Summary (Full Text)

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K04-0559

## JUN - 4 2004

| Section 2 Summary<br>510(k) Summary of Safety and Effectiveness | |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 1, 2004 |
| 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 |
| Trade Name: | |
| 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: | K033672 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2004

Mr. Andrew Kluessendorf Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223

Re: K040559

Trade/Device Name: Unity Network ID Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: April 21, 2004 Received: May 11, 2004

Dear Mr. Kluessendorf:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de roses was a cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or an 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 If your device is clabories (so as additional controls. Existing major regulations affecting (I MA), it may of subject to same and of Federal Regulations, Title 21, Parts 800 to 898. In your device ean or round in further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I icase that FDA has made a determination that your device complies with other requirements moan that I Dr. Inde made statutes and regulations administered by other Federal agencies. of the Act of ally rederal and of the requirements, including, but not limited to: registration

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## Page 2 -- Mr. Andrew Kluessendorf

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practices and listing (21 CFR 1 art 807), laceming (21 cegulation (21 CFR Part 820); and if requirents as set form in the quality of economic (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to objamiations.
The First with anow you to of substantial equivalence of your device to a premiarket notification. The PDF milling of succem.
Iegally 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), If you desire specific ad not for your as at [phone]. Also, please note the regulation in prease contact the Office or Ochiphan promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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 yours,

Ken Muluy
for Chiu Lin, Ph.D.

Chiu Lin. Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

510(k) filed on March 1, 2004

.

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 (D is management ufrough networks with macpondont boutle vork ID intended to control any of not miended for monitoring purposes, from to the Unity reation systems) it is connected to.

Prescription Use X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(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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Auybulion

(Division Sign-Off) Division of Anesthesiol - General Hospital, Infection Control, Dental Devices

204055 510(k) Number:

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