UNITY NETWORK ID

K051518 · Ge Medical Systems Information Technologies · MWI · Jul 8, 2005 · Cardiovascular

Device Facts

• Record ID: K051518
• Device Name: UNITY NETWORK ID
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 8, 2005
• 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/interface; acquires digital data from eight serial ports connected to independent bedside devices; converts data to Unity Network protocols; transmits data over monitoring network to central stations, clinical information systems, or GE patient monitors. Used in clinical environments; operated by healthcare staff. Device does not perform patient monitoring or control connected equipment; serves solely as a communication bridge for data integration. Benefits include centralized clinical information management and improved data accessibility across hospital networks.

Clinical Evidence

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

Technological Characteristics

Data gateway device; acquires digital data from eight serial ports; converts data to Unity Network protocols for transmission over monitoring networks. Complies with voluntary standards for safety and performance. Software-based data conversion.

Indications for Use

Indicated for data collection and clinical information management via networks connected to independent bedside devices. Not intended 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 (K040559)

Submission Summary (Full Text)

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JUL - 8 2005

Pg 1/2

K 05/518

| Section 2 Summary<br>510(k) Summary of Safety and Effectiveness | |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 23, 2005 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223<br>USA |
| Contact Person: | Ronald N. Blaski<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | 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: | K040559 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><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><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. |

. I

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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 Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2005

GE Medical Systems Information Technologies c/o Mr. Ronald N. Blaski Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K051518

Trade Name: Unity Network ID V4 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: June 6. 2005 Received: June 10, 2005

Dear Mr. Blaski:

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 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

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## Page 2-Mr. Ronald N. Blaski

or any Federal statutes and regulations administered by other Federal agencies. You must or ally it catal statutes and regulations and 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 (21 CFR Part 820); and if applicable, the electronic forth in the quality by becalls (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro nein marketing your device as described in your Section 510(k) I ms letter will anow you to cognifinating of substantial equivalence of your device to a legally prematics notification. "The elassification 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 If you desire specific acreoliance at [phone]. Also, please note the regulation entitled, Contiact the Office of Company of Set notification" (21CFR Part 807.97) you may obtain. IMISOranuing of reference to preveresponsibilities under the Act may be obtained from the Other general 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,

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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# Indications for Use

510(k) filed on March 1, 2004

510(k) Number (if known):

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.

Prescription Use
(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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K051518

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