MODIFICATION TO: UNITY NETWORK ID

K071982 · Ge Medical Systems Information Technologies · MWI · Sep 21, 2007 · Cardiovascular

Device Facts

• Record ID: K071982
• Device Name: MODIFICATION TO: UNITY NETWORK ID
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 21, 2007
• 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 clinica! devices (independent bedside devices/ information systems) it is connected to.

Device Story

Unity Network ID acts as a data gateway; 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 facilitates data integration; does not perform monitoring or control functions. Benefits include centralized data management and improved clinical information flow.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of risk analysis, requirements reviews, design reviews, subsystem verification, integration testing, final acceptance testing, performance testing, safety testing, and environmental testing.

Technological Characteristics

Data gateway device; features eight serial ports for data acquisition; converts serial data to Unity Network protocols for transmission over monitoring networks. Complies with voluntary standards. Software-based data conversion and network communication.

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 (K051518)

Submission Summary (Full Text)

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K071982

SEP 2 1 2007

| 510(k) Summary of Safety and Effectiveness |
|--------------------------------------------|
|--------------------------------------------|

| Date: | July 18, 2007 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies |
| | 8200 West Tower Avenue |
| | Milwaukee, WI 53223 USA |
| Contact Person: | Lisa M. Baumhardt |
| | Regulatory Affairs Program Manager |
| | GE Medical Systems Information Technologies |
| | Phone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Secondary Contact<br>Person: | John Pendergast |
| | Regulatory Affairs Specialist |
| | GE Medical Systems Information Technologies |
| | Phone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Device Trade Name: | Unity Network ID |
| Common /Usual Name: | Physiological Patient Monitor |
| Classification Names: | 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) |
| Predicate Devices: | K051518 Unity Network ID |
| Device Description: | The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors. |
| | The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station. |
| Intended 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 clinica! devices (independent bedside devices/ information systems) it is connected to. |
| Technology: | The Unity Network ID employs the same functional technology as the predicate device. |

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## Test Summary:

The subject of this 510(k) is a design modification for the Unity Network ID. The Unity Network ID complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:

- Risk Analysis .
- Requirements Reviews ◆
- Design Reviews .
- Subsystem 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 ID is as safe, as effective, and performs as well as the predicate device.

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SEP 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Lisa Baumhardt Regulatory Affairs Program Manager 8200 West Tower Ave Milwaukee, WI 53223

Re: K071982

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: August 23, 2007 Received: August 24, 2007

Dear Ms. Baumhardt:

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. Lisa Baumhardt

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 (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 240-276-0120. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B.Bommemafor

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 K071982

510(k) Number (if known):

Unity Network ID

Indications for Use:

Device Name:

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 _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use AND/OR . (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumma
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number k071982

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