The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS).

The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.

The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use.

The device is for use by qualified personnel only.

Device Description

The Datex-Ohmeda Network (also referred as D-O Network in the related documentation) is a system, which consists of networked devices (which have separate 510(k) clearance) and the actual networking hardware. The networked devices are Datex-Ohmeda and GE products containing a network adapter for physical access to the D-O Network or to the GE Unity Network as well as software modules supporting network access.

The Datex-Ohmeda iCentral (also referred to as D-O iCentral in the related documentation) is the primary maintainer of communication between other networked devices in Datex-Ohmeda Network and is, thus, an essential part of the Datex-Ohmeda Network. The structure and functionality of the revised network corresponds to the structure and functionality of the substantially equivalent predicate device GE Datex-Ohmeda S/5 Network and iCentral '03 (510(k) number: K042771). The only addition to the predicate is that the capability to interface with GE Unity Network has been implemented this being accomplished by an additional network interface card and appropriate new software in the iCentral PC.

The Datex-Ohmeda Network will be used for real-time communication between devices, for record keeping and for data management in a hospital. Practical examples of currently available features are:

Transmission and display of measured values and alarms in the Datex-Ohmeda iCentral screen (central monitoring) and on the screen of another networked monitor (monitor-tomonitor communication). The source of the transferred data can be either a D-O monitor or a Unity Network monitor. In monitor-to-monitor communication the destination is always a D-O monitor.
Anesthesia record keeping.
Storing and transferring of trend and record keeping data in the network. When the patient is moved from one monitor to another, the data can be transferred with the patient. This feature includes also transferring data from/to an external system (HIS, laboratory, etc.) to/from Datex-Ohmeda Network.
Storing and displaying selected waveforms over the whole patient case (Full Disclosure).
Printing of anesthesia records, ICU reports, trend printouts, spirometry loop printouts, waveform snapshot printouts, etc.

The actual networking hardware consists of cabling, patch panels, racks, connectors, repeaters, access points with antennas etc.

AI/ML Overview

The provided text describes a medical device, the Datex-Ohmeda Network and iCentral '05, Sales Revision 4.3, and its 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance metrics in the way one might find for an AI/ML-driven diagnostic device.

Therefore, many of the requested fields regarding acceptance criteria, study design, ground truth, and expert evaluation cannot be directly extracted from the provided text. The submission is for a networking and central station system, not a device that generates diagnostic outputs requiring performance metrics like sensitivity, specificity, or reader improvement.

However, I can extract information related to the device's validation against standards and the general conclusions regarding its safety and effectiveness.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a network and central station system, the "acceptance criteria" are predominantly related to compliance with recognized standards for medical device safety, software, and electromagnetic compatibility, as well as demonstrating substantial equivalence to a predicate device. There are no performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy) for a diagnostic output.

Acceptance Criteria Category	Specific Criteria (Standard/Guidance)	Reported Device Performance / Compliance Status
Electrical Safety	EN60950: 2000 (IEC60950 3rd edition) - Safety of information technology equipment	Assessed against this standard; "device has been thoroughly tested through validation and verification of specifications."
	CAN/CSA-C22.2 No 60950: Information Technology Equipment	Assessed against this standard.
	UL60950: Information Technology Equipment	Assessed against this standard.
EMC/EMI	EN 55022: 1994 (IEC-CISPR 22) - Information technology equipment Radio disturbance characteristics	Assessed against this standard.
	EN 55024: 1998 (IEC-CISPR 24) – IT Equipment Immunity characteristics	Assessed against this standard.
	EMC Directive 89/336/EEC	Assessed against this standard.
Risk Management	ISO 14971 - Medical Devices Application of risk management to medical devices	Assessed against this standard; "possible implications of these modifications to safety and effectiveness were analyzed with Risk Analysis and the conclusion was, that they do not compromise either safety or effectiveness."
Alarm Signals	EN 475 - Medical devices Electrically-generated alarm signals	Assessed against this standard.
	ISO 9703-1, ISO 9703-2 - Anesthesia and respiratory care alarm signals	Assessed against these standards.
Programmable Medical Systems	IEC 60601-1-4 - Medical electrical equipment. Part 1: General requirements for safety. Collateral Standard: Safety requirements for programmable medical systems.	Assessed against this standard.
Software	FDA/ODE Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005	Assessed against this guidance.
	FDA/ODE Guidance for the Off-The-Shelf Software Use in Medical Devices, September 9, 1999	Assessed against this guidance.
Networking	ISO/IEC 8802-3 (ANSI/IEEE 802.3), EIA/TIA-568, EIA/TIA-TSB40 - International network cabling standards	Assessed against these standards.
	ETS 300 826 (1997-11) - Radio Wideband Systems	Assessed against this standard.
Substantial Equivalence	Comparison to predicate device: GE Datex-Ohmeda S/5 Network and iCentral '03 (K042771)	"Substantially equivalent in safety and effectiveness"; "closely corresponds to the structure and functionality" of the predicate.

Study-Specific Information

The provided document describes nonclinical testing primarily focused on compliance with various international and national standards, and internal validation/verification processes. It is not a clinical study with a test set of patient data, ground truth established by experts, or statistical performance metrics as would be typical for a diagnostic algorithm.

Sample size used for the test set and the data provenance: Not applicable in the context of an algorithmic diagnostic study. The "testing" refers to verification and validation of the system against standards and specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic algorithm is not relevant for this type of network system submission.
Adjudication method for the test set: Not applicable.
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. This device is a network and central monitoring system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm for diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device. The "ground truth" for the system's functionality would be adherence to its design specifications and compliance with the referenced technical standards.
The sample size for the training set: Not applicable, as this is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K052972

Page 1 of 4

DEC 2 9 2005

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda Network and iCentral '05,Sales Revision 4.3

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

October 21, 2005

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Datex-Ohmeda Network and iCentral '05,Sales Revision 4.3

COMMON NAME:

Clinical network and central station

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

CFR Section Classification Name Product Code System, network and communication, physiological monitors 870.2300 MSX

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda Network and iCentral '05 is substantially equivalent in safety and effectiveness to the GE Datex-Ohmeda S/5 Network and iCentral '03 (K042771).

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DEVICE DESCRIPTION as required by 807.92(a)(4)

Datex-Ohmeda S/5 Anesthesia Monitor 1 .
Datex-Ohmeda S/5 Compact Anesthesia Monitor 2.
Datex-Ohmeda S/5 Critical Care Monitor 3.
Datex-Ohmeda S/5 Compact Critical Care Monitor 4.
Datex-Ohmeda S/5 Light Monitor રું.
Datex-Ohmeda S/5 Cardiocap 5 Monitor 6.
GE Dash 3000, 4000 and 5000 Patient Monitor 7.
GE Solar 8000M Patient Monitor 8.

Datex-Ohmeda S/5 PocketViewer/WebViewer with L-WEB03 9.
Datex-Ohmeda Network and iCentral, included in this 510(k) 10.

The DeioRecorder for Anesthesia (formerly named as Datex-Ohmeda AS/3 Record Keeper) is also related to the D-O Network as an application using the services provided by the D-O Network. No changes must be made to the Datex-Ohmeda Network and iCentral itself due to a new type of networked device. As a consequence, adding new types of Datex-Ohmeda or GE devices to Datex-Ohmeda Network and GE Unity Network does not in any way affect the safety and effectiveness of Datex-Ohmeda Network or iCentral, if the devices are using the same protocols and the same design principles are followed as in the currently networked Datex-Ohmeda Network and GE Unity Network devices. In such cases, no new 510(k) application will be submitted to update the list of networked devices.

The Datex-Ohmeda Network will be used for real-time communication between devices, for record keeping and for data management in a hospital. Practical examples of currently available features are:

Transmission and display of measured values and alarms in the Datex-Ohmeda iCentral . screen (central monitoring) and on the screen of another networked monitor (monitor-tomonitor communication). The source of the transferred data can be either a D-O monitor or a Unity Network monitor. In monitor-to-monitor communication the destination is always a D-O monitor.
Anesthesia record keeping. .
Storing and transferring of trend and record keeping data in the network. When the . patient is moved from one monitor to another, the data can be transferred with the patient. This feature includes also transferring data from/to an external system (HIS, laboratory, etc.) to/from Datex-Ohmeda Network.
. Storing and displaying selected waveforms over the whole patient case (Full Disclosure).
Printing of anesthesia records, ICU reports, trend printouts, spirometry loop printouts, . waveform snapshot printouts, etc.

The actual networking hardware consists of cabling, patch panels, racks, connectors, repeaters, access points with antennas etc.

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All these products are also provided as part of separate upgrade products, namely U-LIFE3 & C-LIFE3 (parts of a larger S/5 L.I.F.E. upgrade program).

INTENDED USE as required by 807.92(a)(5)

Indications for use:

The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity NetworkTM. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS).

The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use.

The device is for use by qualified personnel only.

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda Network and iCentral '05 is substantially equivalent in safety and effectiveness to the GE Datex-Ohmeda S/5 Network and iCentral '03 (K042771) currently in distribution.

Similarities:

The indications for use are almost the same as in the predicate. The intended use for the modified device is the same as for the predicate; only the product name has changed from 'GE Datex-Ohmeda S/5 Network and iCentral' to 'Datex-Ohmeda Network and iCentral' and the ability to communicate with devices in GE Unity Network has been added. The structure and functionality of the Datex-Ohmeda Network and iCentral '05 closely corresponds to the structure and functionality of the GE Datex-Ohmeda S/5 Network and iCentral '03 (predicate). The basic architecture of Datex- Ohmeda Network and iCentral '05 is the same as that of GE Datex-Ohmeda S/5 Network and iCentral '03 (predicate).

Differences: The following functionalities were modified since the predicate device clearance of GE Datex-Ohmeda S/5 Network and iCentral '03

1. Operating system image corrections
1. Modifications related to Sales Revision 3.4
1. Modifications related to Sales Revision 3.5
1. Modifications related to Sales Revision 3.6 (in parallel with iC '05 ver 4.3)
1. Operating system image corrections
1. Modifications related to Sales Revision 4.0
1. Modifications related to Sales Revision 4.1
1. Modifications for Sales Revision 4.2

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A new PC model HP xw4200 has been validated as the network computer C-2KNET3 for Datex-Ohmeda iCentral.
Modifications related to Sales Revision 4.3

The possible implications of these modifications to safety and effectiveness were analyzed with Risk Analysis and the conclusion was, that they do not compromise either safety or effectiveness.

Summary:

In summary, the new Datex-Ohmeda Network and iCentral '05, described in this submission is substantially equivalent to the predicate device (K042771).

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda Network and iCentral '05 has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

EN60950: 2000 (IEC60950 3rd edition) Safety of information technology . equipment, including electrical business equipment
EN 55022: 1994 (IEC-CISPR 22) Information technology equipment Radio . disturbance characteristics. Limits and methods of measurement
EN 55024: 1998 (IEC-CISPR 24) –IT Equipment Immunity characteristics .
EMC Directive 89/336/EEC .
Low Voltage Directive 73/23/EEC .
ISO 14971, Medical Devices Application of risk management to medical . devices
EN 475, Medical devices Electrically-generated alarm signals ISO 9703-1, ISO . 9703-2, Anesthesia and respiratory care alarm signals
IEC 60601-1-4Medical electrical equipment. Part 1: General requirements for . safety4. Collateral Standard: Safety requirements for programmable medical systems.
CAN/CSA-C22.2 No 60950: Information Technology Equipment Including . Electrical Business Equipment
UL60950: Information Technology Equipment Including Electrical Business ◆ Equipment
FDA/ODE Guidance for the Content of Premarket Submission for Software . Contained in Medical Devices, May 11, 2005
FDA/ODE Guidance for the Off-The-Shelf Software Use in Medical Devices, . September 9, 1999
ISO/IEC 8802-3 (ANSI/IEEE 802.3), EIA/TIA-568, EIA/TIA-TSB40, t international network cabling standards
ETS 300 826 (1997-11) Radio Wideband Systems .

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda Network and iCentral '05 and it is substantially equivalent to the GE Datex-Ohmeda S/5 Network and iCentral '03 (K042771).

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Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus-like symbol with three curved lines emanating from a central point, representing health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2005

GE Healthcare c/o Mr. Joel Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

Re: K052972

K052972
Trade Name: Datex-Ohmeda Network and iCentral '05, Sales Revision 4.3 Regulation Number: 21 CFR 870.2300 Regulation Name: 21 CF CF CF CF CF 070.2500
Regulation Name: Cardiac Monitor (including cardiotachometer and alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: December 03, 2005 Received: December 05, 2005, 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(t) premained is substantially equivalent (for the indications relerenced and nave determined we as a credicate devices marketed in interstate for use stated in the clerosure) to regars nament date of the Medical Device Ameralments, or to commerce prior to May 26, 1970, the enaounce with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the relie devices that have been reclassified in accordains we a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The You may, merciole, market the device, belower to the ments for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 above) and existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs announcements concerning your device in the Federal Register.

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Page 2 - Mr. Joel Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a bucking with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that I DA has made a decommiation administered by other Federal agencies. You must or any Pederal Statutes and regulations daminders, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercedes, and manufacturing practice requirements as set CFR Part 607), labeling (21 CFR Part 807), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons of a concelled in your Section 510(k)
This letter will allow you to begin marketing your device as described in your since to Ja I his letter will anow you to begin manetally your intial equivalence of your device to a legally premarket nothication. The PDA miang of backanna 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 if you desire specific advice for Jour as 110 % 0120. Also, please note the regulation entitled, contact the Office of Compunation as (217) = 15 = 1 807.97). You may obtain Misoranting by reference to premanovaibilities under the Act from the Division of Small other gelleral informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Colisanel Processes of the markets http://www.fdindex.html.

Sincerely vours,

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda Network and iCentral '05,Sales Revision 4.3.

Indications for use:

The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.

The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use.

The device is for use by qualified personnel only.

Prescription Use X AND/OR Over-The-Counter Use ___________
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
for Bram D Zuckerman MD	Page ___ of ___
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K052972

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).