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 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.

AI/ML Overview

The provided documentation does not contain information about acceptance criteria, device performance metrics, or a study that evaluates the device's diagnostic performance for medical insights in the way one would typically assess an AI/ML medical device.

The GE Medical Systems Information Technologies Unity Network ID (K021454) is a data communication and management system, not a diagnostic device that generates interpretations or analyses of patient data. Its purpose is to acquire digital data from various medical devices, convert it to a common protocol, and transmit it to other systems like patient monitors, clinical information systems, or central stations.

The "Test Summary" section describes quality assurance measures applied during development, such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, acceptance, performance, safety, environmental). However, these are developmental tests to ensure the system functions as designed and is safe and effective in its intended role as a data conduit, not to assess its ability to provide clinical insights or make diagnoses.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this device and are not present in the provided submission.

Based on the provided text, here’s a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied)	Reported Device Performance
Functionality	Acquire digital data from 8 serial ports, convert to Unity Network protocols, transmit data over the network to a Unity Network device.	Device described as performing this function. No specific numerical performance metrics (e.g., data transfer speed, error rates) are provided beyond the general statement that "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."
Safety	Compliance with voluntary standards (as detailed in Section 9 of the submission, but not provided here). Risk analysis conducted.	Safety testing performed. Conclusion: "The results of these measurements demonstrated that the Unity Network ID is as safe... as the predicate device."
Effectiveness	Perform as well as the predicate device (Phillips Medical Systems, Inc., M2376A Device Link System – K012094) in terms of data collection and clinical information management.	Performance testing performed. Conclusion: "The results of these measurements demonstrated that the Unity Network ID is... as effective, and perform as well as the predicate device."
Connectivity/Protocol Conversion	Employ same functional scientific technology as predicate device for data acquisition and conversion.	"The Unity Network ID employs the same functional scientific technology as its predicate device."
Quality Assurance	Adherence to specified development processes (Risk Analysis, Requirements Reviews, Design Reviews, Unit testing, Integration testing, Final acceptance testing).	All listed quality assurance measures were applied.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The device is a data communication system. The testing described includes unit, integration, and final acceptance testing, as well as performance, safety, and environmental testing. These types of tests typically involve controlled lab environments and specific test cases designed to test system functionality, communication integrity, and adherence to power/environmental standards, rather than a "test set" of patient data in the context of diagnostic performance. There is no mention of patient data being used for device performance evaluation in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth for diagnostic accuracy is not relevant for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Not provided. This device is not an AI/ML diagnostic tool; it's a data network interface.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided. The device's function is purely data transmission and conversion; it does not provide an "algorithm only" diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Not provided. The "truth" for this device relates to whether data is accurately acquired, converted, and transmitted without corruption, and whether it functions according to its specifications and regulatory standards. There is no diagnostic ground truth.

8. The sample size for the training set

Not applicable / Not provided. This device is not an AI/ML model that would require a "training set" of data in that sense.

9. How the ground truth for the training set was established

Not applicable / Not provided.

Summary

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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 Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Joelle NeiderRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (203) 949-8232Fax: (414) 918-8113Email: joelle.neider@med.ge.com
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,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.

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

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

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).