UNITY NETWORK ID

K021454 · General Electric Medical Systems Information Techn · MWI · Oct 1, 2002 · Cardiovascular

Device Facts

• Record ID: K021454
• Device Name: UNITY NETWORK ID
• Applicant: General Electric Medical Systems Information Techn
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

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; acquires digital data from eight serial ports connected to independent bedside clinical devices; converts data to Unity Network protocols; transmits data over monitoring network to central stations, clinical information systems, or patient monitors. Used in clinical environments; operated by healthcare professionals. Device does not perform monitoring or control functions; serves solely as a communication bridge for data integration. Benefits include centralized access to patient data from disparate bedside equipment.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of module verification, system integration testing, performance testing, safety testing, and environmental testing to ensure compliance with voluntary standards.

Technological Characteristics

Data gateway with eight serial ports; converts serial data to Unity Network protocols for network transmission. Operates as a communication interface between bedside devices and clinical information systems. Does not perform physiological monitoring or device control. Development followed quality assurance measures including risk analysis, design reviews, and verification/validation testing.

Indications for Use

Indicated for data collection and clinical information management via networks connecting 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

• Phillips Medical Systems, Inc., M2376A Device Link System (K012094)

Submission Summary (Full Text)

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# OCT 01 2002

### Section 2 Summary and Certification

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 2, 2002 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Joelle Neider<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device: Trade Name: | Unity Network ID |
| Common/Usual Name: | Monitor, Physiological, Patient (without arrhythmia detection or alarms) |
| Classification Names: | 21 CFR 870.2300 |

Classification for the externally connected devices are as follows:

| Regulation Number | Classification Name | Panel | Procode |
|-------------------|-----------------------------------------------------|------------------|---------|
| 870.1110 | Computer, blood pressure | Cardiovascular | 74 DSK |
| 870.1130 | System, measurement, blood pressure,<br>noninvasive | Cardiovascular | 74 DXN |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 876.1800 | Urinometer | Gastro-urology | 78 EXS |
| 880.5725 | Pump, infusion | General hospital | 80 FRN |
| 870.3535 | System, balloon, intra-aortic and control | Cardiovascular | 74 DSP |
| 868.5895 | Continuous ventilator | Anesthesiology | 73 CBK |
| 868.1730 | Computer, oxygen uptake | Anesthesiology | 73 BZL |
| 870.2700 | Oximeter | Cardiovascular | 74 DQA |
| 868.1400 | Carbon Dioxide Gas Analyzer | Anesthesiology | 73 CCK |
| 870.1915 | Thermodilution probe | Cardiovascular | 74 QGL |
| 868.2375 | Breathing Frequency Monitor | Anesthesiology | 73 BZQ |
| 868.2480 | Monitor, Carbon Dioxide, Cutaneous | Anesthesiology | 74 LKD |

Predicate Devices:

Phillips Medical Systems, Inc., M2376A Device Link System – K012094

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K021454
p. 2/2

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:

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.

#### Technology:

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

#### Test Summary:

The Unity Network ID and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:

- . 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

#### Conclusion:

The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and perform as well as the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 01 2002

GE Medical Systems Information Technologies c/o Ms. Joelle Neider Regulatory Affairs Specialist 8200 W. Tower Ave. Milwaukee, WI 53223

Re: K021454

Trade Name: Unity Network ID module Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: August 15, 2002 Received: August 16, 2002

Dear Ms. Neider:

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 cither 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. Joelle Neider

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Kalkman

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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Page 1 of 1

510(k) Number (if known):

K021454 Unknown; 510(k) filed on May 2, 2002

Device Name: Unity Network ID

Indications for Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

Oak Tun
Division of Cardiovascular & Respiratory Devices
510(k) Number K021454