The Unity Network® Patient Data Server (PDS) is intended for use under the direct supervision of a licensed healthcare practitioner. The Unity Network® Patient Data Server is intended to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network® Patient Data Server can be accessed via any (authorized) device that implements the PDS data exchange protocol. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station.

Device Description

The Unity Network® Patient Data Server provides a caregiver the ability to view patient centric events and physiological data that was collected from acquisition devices on the Unity Network prior to the current monitoring session. The Unity Network® Patient Data Server stores at least 500 alarm histories (400 arrhythmia events and 100 ST history events) and at least 72 hours of physiological data per unique patient identifier. Information from the Unity Network® Patient Data Server can be accessed by a GEMS-IT device that implements the Unity Network® Patient Data Server's proprietary data exchange protocol.

The Unity Network® Patient Data Server is a system of hardware and software that operates on standard commercially available server class hardware and interfaces with the Unity Network®. The Unity Network® Patient Data Server system obtains and stores data from devices that are connected and admitted to a monitoring device on the Unity Network® and relays that data to connected clients for viewing. Only clients that are connected to Unity Network® and have access to a proprietary application protocol interface can access the data stored in the Unity Network® Patient Data Server.

The Unity Network® Patient Data Server system provides data to central station monitoring devices, and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions. In the event that data is not available via the Unity Network® Patient Data Server, the clinician is instructed to obtain the data from the primary bedside monitor.

AI/ML Overview

The Unity Network® Patient Data Server is a medical device, and the information provided details its intended purpose and the general testing conducted to ensure its safety and effectiveness. However, it does not present specific acceptance criteria in the form of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, data retention rates within a certain tolerance) that a study would then prove the device meets.

Instead, the submission focuses on validation of the development process and system functionality rather than a statistical performance study against defined clinical endpoints or ground truth.

Here's an breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Derived from document)	Reported Device Performance (Derived from document)
Compliance with Voluntary Standards	Complies with voluntary standards as detailed in Section 9 of the submission.
Risk Analysis Conducted	Applied in development.
Requirements Reviews Conducted	Applied in development.
Design Reviews Conducted	Applied in development.
Unit Level Testing (Module Verification)	Conducted.
Integration Testing (System Verification)	Conducted.
Final Acceptance Testing (Validation)	Conducted.
Performance Testing	Conducted.
Safety Testing	Conducted.
Environmental Testing	Conducted.
Functional Equivalence to Predicate Device	"The results of these measurements demonstrated that the Unity Network® Patient Data Server is as safe, as effective, and perform as well as the predicate device."
Storage Capacity (Events)	Stores at least 500 alarm histories (400 arrhythmia events and 100 ST history events).
Storage Capacity (Physiological Data)	Stores at least 72 hours of physiological data per unique patient identifier.

Important Note: The document does not provide specific numerical "acceptance criteria" for metrics like data integrity, retrieval speed, or specific error rates. The acceptance is based on the successful completion of various testing phases within the product development lifecycle and a general claim of equivalence to the predicate device.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical cases to evaluate performance against a ground truth. The testing described (unit, integration, acceptance, performance, safety, environmental) refers to software and hardware validation, not a clinical performance study with annotated data. Therefore, information on sample size and data provenance (e.g., retrospective/prospective, country of origin) is not applicable in the sense of a diagnostic or predictive AI device.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Since there is no mention of a "test set" requiring ground truth established by experts for clinical performance, this information is not provided. The device is a data server, not a diagnostic tool that interprets physiological data.

4. Adjudication Method

Not applicable. As there's no clinical performance test set, there's no need for an adjudication method by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The Unity Network® Patient Data Server is a data storage and retrieval system, not an AI algorithm that assists human readers in interpreting medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or described.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a data server. While its software has functionalities and performance metrics (e.g., data storage capacity, retrieval speed, which are alluded to with "performance testing"), it's not a standalone "algorithm" in the sense of a medical AI that generates diagnostic or prognostic outputs. Its performance is evaluated through system tests and validation of its intended functions.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/medical device performance studies (e.g., pathology reports, follow-up outcomes, expert consensus on disease presence) is not applicable to this device. The "ground truth" for a data server would more appropriately be the accurate storage, retrieval, and integrity of the original physiological data and events as generated by the monitoring devices. The document implies that the "tests" (unit, integration, acceptance) verified this functional accuracy.

8. Sample Size for Training Set

Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset. It is a software and hardware system designed for data management.

9. How Ground Truth for Training Set Was Established

Not applicable. Since there is no training set for an AI algorithm, this information is not relevant.

Summary

{0}------------------------------------------------

K032582 p1/2

SEP 1 7 2003

Unity Network® Patient Data Server 510k Premarket Notification Submission

Section 2 Summary and Certification

510(k) Summary of Safety and Effectiveness
Date:	August 18, 2003
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Karen LundeSr. Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (414) 362-3329Fax: (414) 918-8114
Device:
Trade Name:	Unity Network® Patient Data Server
Common/Usual Name:	Computer, Information Network Server
Classification Names:	21 CFR 870.2300 System, Network and Communication, Physiological
Predicate Device:	K001268 GE Marquette Prism Information Server Applications (MPIS)
Device Description:	The Unity Network® Patient Data Server provides a caregiver the abilityto view patient centric events and physiological data that was collectedfrom acquisition devices on the Unity Network prior to the currentmonitoring session. The Unity Network® Patient Data Server stores atleast 500 alarm histories (400 arrhythmia events and 100 ST historyevents) and at least 72 hours of physiological data per unique patientidentifier. Information from the Unity Network® Patient Data Server canbe accessed by a GEMS-IT device that implements the Unity Network®Patient Data Server's proprietary data exchange protocol.The Unity Network® Patient Data Server is a system of hardware andsoftware that operates on standard commercially available server classhardware and interfaces with the Unity Network®. The Unity Network®Patient Data Server system obtains and stores data from devices thatare connected and admitted to a monitoring device on the UnityNetwork® and relays that data to connected clients for viewing. Onlyclients that are connected to Unity Network® and have access to aproprietary application protocol interface can access the data stored inthe Unity Network® Patient Data Server.The Unity Network® Patient Data Server system provides data tocentral station monitoring devices, and is NOT a patient monitoringdevice. The clinician is instructed to always reference the primarybedside monitor before making any patient care decisions. In the eventthat data is not available via the Unity Network® Patient Data Server,the clinician is instructed to obtain the data from the primary bedside

{1}------------------------------------------------

K052582 p2/2

Unity Network® Patient Data Server 510k Premarket Notification Submission

Intended Use: The Unity Network® Patient Data Server (PDS) is intended for use under the direct supervision of a licensed healthcare practitioner. The Unity Network® Patient Data Server is intended to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network® Patient Data Server can be accessed via any (authorized) device that implements the PDS data exchange protocol. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station.
- Technology: The Unity Network® Patient Data Server system consists of standard server class hardware purchased from an OEM and loaded with application software developed by GE Medical Systems Information Technologies.

The server is connected to two networks: Unity Network® and the hospital's Intranet. The Unity Network® is a currently marketed proprietary network connecting patient monitors. Applications communicate over the Unity Network® using a proprietary protocol in order to obtain or provide data to devices on the network. The hospital's Intranet refers to the existing network within the hospital from which a user can gain access to the product for configuration and servicing.

Test Summary:

The Unity Network® Patient Data Server 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 Unity Network® Patient Data Server:

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® Patient Data Server is as safe, as effective, and perform as well as the predicate device.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows a black and white seal. The seal is circular and contains an image of an eagle with three lines representing its wings. The text around the seal reads "HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2003

GE Medical Systems Information Technologies c/o Ms. Karen Lunde Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K032582

Trade Name: Unity Network® Patient Data Server Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm). Regulatory Class: Class II (two) Product Code: MSX Dated: August 18, 2003 Received: August 21, 2003

Dear Ms. Lunde:

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

{3}------------------------------------------------

Page 2 - Ms. Karen Lunde

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), please contact the Office of Compliance at (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Prem D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

Unknown; 510(k) filed on August 11, 2003 510(k) Number (if known):

Unity Network® Patient Data Server Device Name

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Valeria

510(k) |

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).