The GE Datex-Ohmeda S/5™ Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several iCentrals. Within one Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices.

The GE Datex-Ohmeda S/5™ iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in GE Datex-Ohmeda 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 GE Datex-Ohmeda S/5TM Network as well as between the GE Datex-Ohmeda Network and Hospital Information Systems (HIS).

The GE Datex-Ohmeda S/5™ 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 GE Datex-Ohmeda S/5™ 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 GE Datex-Ohmeda S/5 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 products containing a network adapter for physical access to the D-O Network as well as software modules supporting network access. Examples of currently available networked devices are:

1 . Datex-Ohmeda S/5 Anesthesia Monitor
1. Datex-Ohmeda S/5 Compact Anesthesia Monitor
1. Datex-Ohmeda S/5 Critical Care Monitor
1. Datex-Ohmeda S/5 Compact Critical Carc Monitor
1. Datex-Ohmeda S/5 Light Monitor
Datex-Ohmeda S/5 Cardiocap 5 Monitor 6.
1. Datex-Ohmeda S/5 WebViewcr
1. Datex-Ohmeda S/5 PocketViewer/WebViewer with L-WEB03
ੇ GE Datex-Ohmeda S/5 Network and iCentral, included in this 510(k)

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 GE Datex-Ohmeda S/5 Network and iCentral itself due to a new type of networked device. As a consequence, adding new types of Datex-Ohmeda devices to GE Datex-Ohmeda Network does not in any way affect the safety and effectivencss of GE Datex-Ohmeda Network or iCentral, if the devices are using the same protocol and the same design principles are followed as in the currently networked Datex-Ohmeda devices. In such cases, no new 510(k) application will be submitted to update the list of networked devices. The GE Datex-Ohmeda S/5 iCentral (also referred to as D-O iCentral in the rclated documentation) is the primary maintainer of communication between other networked devices and is, thus, an essential part of the network. The structure and functionality of the revised network corresponds to the structure and functionality of the substantially equivalent predicate device Datex-Ohmeda Network and Central '03 (510(k) number: K033281).

The GE 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 GE Datex-Ohmeda S/5 iCcntral screen (central monitoring) and on the screen of another networked monitor (monitor-to-monitor communication).
- 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 GE Datex-Ohmeda S/5 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. The networking hardware is similar to the networking hardware of the substantially equivalent predicate device Datex-Ohmeda Network and Central '03 (510(k) number: K033281).

Modifications to the predicate device Datex-Ohmeda Network and iCentral '03 K033281

Navigating PDF printouts based on patient names. 1.
1. Change of the display option D-LCC19.
1. Revision change of the display option D-CFLT17.
1. Using the latest display driver for the Matrox G450 display card.
1. A new PC for the S/5 iCentral network computer.
Distributed patient data over several networked S/5 iCentrals. (). 7. Limited iCentral functionality with iCentral Client product.
1. Localization to 11 languages.
্ Compatibility with Symantec virus scanner
1. Improved Full Disclosure printout.
】 1 . Possibility to generate an event history printout.
1. Improved Multi View patient sector setup.
I 3. Possibility to define the defaults to use in a patient sector.
14 Support for Datex-Ohmeda S/5 FM monitor.
ા રે . Improved time synchronization.

AI/ML Overview

This FDA submission (K042771) describes a medical device, the GE Datex-Ohmeda S/5 Network and iCentral '03, Sales Revision 3.3. However, this document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or accuracy for diagnostic purposes. Instead, it is a Premarket Notification 510(k) Summary focused on demonstrating substantial equivalence to a previously cleared predicate device (Datex-Ohmeda S/5 Network and iCentral '03, K033281).

The "acceptance criteria" discussed in this document relate to compliance with regulatory standards and the device performing its intended functions as a network and central station for physiological monitors, similar to its predicate.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for substantial equivalence of a network and central station, the "performance" is primarily about compliance with standards and successful new functionalities rather than diagnostic accuracy metrics.

Acceptance Criteria (Compliance/Functionality)	Reported Device Performance
Safety and Effectiveness	"GE Datex-Ohmeda S/5 Network and iCentral '03,Sales Revision 3.3 complies with the safety standards below and is therefore safe and effective for the intended use."
Regulatory Standards Compliance	Verified compliance with: EN60950, EN 55022, EN 55024, EMC Directive 89/336/EEC, Low Voltage Directive 73/23/EEC, EN 1441, EN 475, ISO 9703-1, ISO 9703-2, IEC 60601-1-4, CAN/CSA-C22.2 No 60950, UL60950, FDA/ODE Guidances, ISO/IEC 8802-3, EIA/TIA-568, EIA/TIA-TSB40, ETS 300 826.
Intended Use Fulfillment	The device "transfers information between networked Datex-Ohmeda devices," "maintains network connections," and "coordinates the transfer of information." It also supports "remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information."
New Functionalities Performance	The document implies successful implementation and functionality of the 15 listed modifications (e.g., navigating PDF printouts, distributed patient data, localization, virus scanner compatibility, improved printouts, time synchronization). Risk analysis concluded these "do not compromise either safety or effectiveness."
Substantial Equivalence	Concluded to be substantially equivalent to the predicate device (K033281).

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

No specific sample size for a test set is mentioned in the context of clinical performance or diagnostic accuracy, as this is not a diagnostic device with performance claims.
The "testing" mentioned is primarily nonclinical testing for compliance with safety standards and verification of new functionalities. This would generally involve internal testing, not a clinical "test set" with patient data.
Data provenance is not applicable in the same way it would be for a clinical trial. The device manufacturer (Datex-Ohmeda, an affiliate of GE) is based in Needham, MA, USA, but testing would have occurred internally or at certified labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document does not describe a study involving expert-established ground truth for a test set, as it's not a diagnostic AI/ML device but rather a network and central station for existing physiological monitors. The "experts" involved would likely be engineers, quality assurance personnel, and regulatory specialists validating the device's adherence to technical standards and specifications.

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

Not applicable. No clinical test set or adjudication method is described.

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

No. This type of study is completely irrelevant to the device described (a clinical network and central station).

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

Not applicable. This device is a system for managing and displaying data from other medical devices, not a standalone diagnostic algorithm. Its performance is evaluated in terms of its networking capabilities, data integrity, and compliance with standards.

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

Not applicable. For this type of device, "ground truth" would relate to the correct functioning of the network, accurate data transmission, proper display of information, and adherence to established technical specifications and regulatory standards. This is verified through engineering tests, software validation, and hardware testing, not clinical "ground truth" labels.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that employs a "training set."

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

Not applicable. As no training set is used, no ground truth for a training set was established.

In summary: This 510(k) submission primarily demonstrates that the updated GE Datex-Ohmeda S/5 Network and iCentral '03, Sales Revision 3.3 is substantially equivalent to a previously cleared predicate device. The "acceptance criteria" are met through nonclinical testing verifying compliance with a comprehensive list of safety and performance standards, and through risk analysis confirming that modifications do not compromise the device's safety or effectiveness. This is a crucial distinction from AI/ML diagnostic devices, which typically require extensive clinical performance studies with defined acceptance criteria and ground truth derived from expert review, pathology, or outcomes data.

Summary

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OCT 15 2004

Image /page/0/Picture/1 description: The image shows the text "K042771" in a handwritten style. Below the text, it says "Page 1 of 5" in a smaller font. The text appears to be a page number or document identifier.

Premarket Notification 510(k) Summary As required by section 807.92 GE Datex-Ohmeda S/5 Network and iCentral '03,Sales Revision 3.3

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

COMPANY NAME/ADDRESS/PHONE/FAX:

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

NAME OF CONTACT:

Mr. Jocl Kent

DATE:

July 28, 2004

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

TRADE NAME:

GE Datex-Ohmeda S/5 Network and iCentral '03,Sales Revision 3.3

COMMON NAME:

Clinical network and central station

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

MSX System, network and communication, physiological monitors 870.2300

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

The GE Datex-Ohmeda S/5 Network and iCentral '03 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmcda S/5 Network and iCentral '03 (K033281).

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

1 . Datex-Ohmeda S/5 Anesthesia Monitor
1. Datex-Ohmeda S/5 Compact Anesthesia Monitor
1. Datex-Ohmeda S/5 Critical Care Monitor
1. Datex-Ohmeda S/5 Compact Critical Carc Monitor
1. Datex-Ohmeda S/5 Light Monitor
Datex-Ohmeda S/5 Cardiocap 5 Monitor 6.
1. Datex-Ohmeda S/5 WebViewcr
1. Datex-Ohmeda S/5 PocketViewer/WebViewer with L-WEB03
ੇ GE Datex-Ohmeda S/5 Network and iCentral, included in this 510(k)

The GE 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 GE Datex-Ohmeda S/5 iCcntral screen (central monitoring) and on the screen of another networked monitor (monitor-to-monitor communication).
- 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 GE Datex-Ohmeda S/5 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.

Modifications to the predicate device Datex-Ohmeda Network and iCentral '03 K033281

Navigating PDF printouts based on patient names. 1.
1. Change of the display option D-LCC19.
1. Revision change of the display option D-CFLT17.
1. Using the latest display driver for the Matrox G450 display card.
1. A new PC for the S/5 iCentral network computer.

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

Distributed patient data over several networked S/5 iCentrals. (). 7. Limited iCentral functionality with iCentral Client product.
1. Localization to 11 languages.
্ Compatibility with Symantec virus scanner
1. Improved Full Disclosure printout.
】 1 . Possibility to generate an event history printout.
1. Improved Multi View patient sector setup.
I 3. Possibility to define the defaults to use in a patient sector.
14 Support for Datex-Ohmeda S/5 FM monitor.
ા રે . Improved time synchronization.

Modifications to Labeling

Modifications to the User's Manual: .
. Modifications are related to distributed patient data access and iCentral Client
. Modifications to the Technical Reference Manual:
Modifications are related to distributed patient data access and iCentral Client .

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

Intended use:

The GE Datex-Ohmeda S/5 Network and Central is intended to be used with Datcx-Ohmeda devices for displaying, storing, printing and otherwise processing information received from other networked devices.

Indications for use:

The GE Datex-Ohmcda S/5TM Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several iCentrals. Within onc Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices.

The GE Datex-Ohmeda S/5TM iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in GE Datex-Ohmeda 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 GE Datex-Ohmeda S/5TM Network as well as between the GE Datex-Ohmeda Network and Hospital Information Systems (HIS).

The GE Datex-Ohmeda S/5TM 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 GE Datex-Ohmeda S/5TM 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.

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

The GE Datex-Ohmeda S/5 Network and iCentral '03 is substantially cquivalent in safety and effectiveness to the Datex-Ohmeda S/5 Network and iCentral '03 (K033281) currently in distribution.

Similarities:

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

Differences:

The following functionalities were modified

Navigating PDF printouts based on patient names.
Change of the display option D-LCC19.
Revision change of the display option D-CFLT17.
Using the latest display driver for the Matrox G450 display card.
A new PC for the S/5 iCentral network computer.
Distributed patient data over several networked S/5 iCentrals.
Limited iCentral functionality with iCentral Client product.

8 Localization to 11 languages.

Compatibility with Symantec virus scanner.

10 Improved Full Disclosure printout.

11 Possibility to generate an event history printout.

Improved Multi View patient sector setup.
Possibility to define the defaults to use in a patient sector.
Support for Datex-Ohmeda S/5 FM monitor.

15.1mproved time synchronization.

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 GE Datex-Ohmeda S/5 Network and iCentral, described in this submission is substantially equivalent to the predicate device (K033281).

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

GI: Datex-Ohmeda S/5 Network and iCentral '03,Sales Revision 3.3 complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made:

EN60950: 2000 (IEC60950 3rd edition) Product Safety .
EN 55022: 1998 (IEC-CISPR 22) -- Radio Frequency Interface .
EN 55024: 1998 IT Equipment -Immunity characteristics .
EMC Directive 89/336/EEC (including amendments) .
Low Voltage Directive 73/23/EEC(amended by 93/68/EEC) .
EN 1441, Medical devices Risk analysis .
EN 475, Medical devices Electrically-generated alarm signals .
ISO 9703-1, ISO 9703-2, Anesthesia and respiratory care alarm signals .
IEC 60601-1-4 Medical electrical equipment. Part 1: General requirements for safety 4. . 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 29,1998
FDA/ODE Guidance for the Off-The-Shelf Software Use in Medical Devices, September 9, � 1 9999
ISO/IEC 8802-3 (ANSI/IEEE 802.3),EIA/TIA-568, EIA/TIA-TSB40,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 GE Datex-Ohmeda S/5 Network and iCentral '03,Sales Revision 3.3 as compared to the predicate device.

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Image /page/5/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of an eagle.

Roo

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 15 2004

Datex-Ohmeda c/o Mr. Joel Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

Re: K042771

K042771
Trade Name: GE Datex-Ohmeda S/5 Network and iCentral `03, Sales Revicion 3.3
Trade Name: GE Datex-Ohment and ance Regulation Number: 21 CFR 870.2300 Regulation Number: 21 CFR 870.2300
Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MSX Dated: October 2, 2004 Received: October 5, 2004

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 3 IQ(x) premaise is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed prodical Device Amendments, for use stated in the enclosure) to tegally intakect te of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment with the neovisions of the Feder commerce prior to May 28, 1976, the claculties with the provisions of the Federal Food, Drug, devices that have been reclassined in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval annusions of the Act. The and Cosmetic Act (Act) that do not require approval or the general controls of the Act. The
You may, therefore, market the device, subject to the general controls of listin You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act Include requirements of the security 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 (sec above) in critics and in perculations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additional controlist Listing may or 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, 11 be found in the Couc of Pederal Regarations, your device in the Federal Register.

{6}------------------------------------------------

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 Dri 3 issuation of a basice complies with other requirements of the Act
that FDA has made a determination that your device complies with other requir that IDA has made a decormination administered by other Federal agencies. You must of any iredical statutes and regulations and and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), ademig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (overies (overies as described in your Section 510(k) This letter will anow you to begin manically your manitoung your device of your device to a legally premarket nothcation: "The FDA maing of basis.ification 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 davice for your as (301) 594-4646. Also, please note the regulation entitled, Colliact the Office of Compilance w (s st notification" (21CFR Part 807.97) you may obtain. IMISoranumly by reference to premarsponsibilities under the Act may be obtained from the Other general information on your responsional 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,

Blumeno for

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: GE Datex-Ohmeda S/5 Network and iCentral '03,Sales Revision 3.3

Indications for Use:

The GE Datex-Ohmeda S/5™ 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.

Over-The-Counter Use Prescription Use_ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummenroe
Division Sign-Off

ardiovascul 510(k) Number

Page | of |

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).