UNITY NETWORK ID

K103432 · Ge Medical Systems Information Technologies, Inc. · MWI · Dec 17, 2010 · Cardiovascular

Device Facts

• Record ID: K103432
• Device Name: UNITY NETWORK ID
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 17, 2010
• 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 functions as a data gateway/bridge; acquires digital data from eight serial ports of third-party clinical devices; converts data to proprietary Unity Network protocols; transmits data over monitoring network to patient monitors, central stations, or clinical information systems. Used in clinical environments; operated by healthcare staff. Device does not perform patient monitoring; does not control connected bedside equipment. Benefits include centralized data management and integration of disparate clinical information into GE monitoring infrastructure.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through risk analysis, requirements reviews, design reviews, subsystem verification, integration testing, final acceptance testing, and environmental testing.

Technological Characteristics

Data gateway with eight serial ports. Converts third-party serial data to Unity Network protocols for transmission over monitoring networks. Design modification of predicate device. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for data collection and clinical information management via networks connected to independent bedside clinical 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 (K071982)

Submission Summary (Full Text)

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# DEC 1: 7 2010

#### 510(k) Summary of Safety and Effectiveness Date: November 18, 2010 Submitter: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue USA Milwaukee, WI 53223 Contact Person: Robert Casarsa Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Phone: [phone] Fax: [phone] E-mail: [e-mail] Secondary Contact Robin Fitzgerald Person: Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. 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 Device: K071982 Unity Network ID Device Description: The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. 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. The Unity Network ID is indicated for use in data collection and Intended Use: information management through networks with clinical The Unity Network ID is not independent bedside devices.

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.

19

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#### Technology:

ﺮ

The Unity Network ID employs the same functional technology as the predicate device.

#### 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 9.2 - 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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# DEC 1: 7 2010

GE Medical Systems Information Technologies, Inc. c/o Mr. Robert L. Casarsa Regulatory Affairs Leader 8200 West Tower Avenue Milwaukee, WI 53223

Re: K103432

Trade/Device Name: Unity Network ID V6 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 22, 2010 Received: November 29, 2010

### Dear Mr. Casarsa:

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 commence 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 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 – Mr. Robert L. Casarsa

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerelv vours.

K

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) Number (if known): Klo 343 Z

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 ctinical devices (independent bedside devices/ information systems) it is connected to.

Prescription Use _ Over-The-Counter Use X 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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

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