Indication for use for S/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for S/5 Pocket Viewer: The Datex-Ohmeda S/5 Pocket Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Pocket Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Pocket Viewer clients. The S/5 Pocket Viewer client runs on a generic handheld computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for S/5 Cellular Viewer: The Datex-Ohmeda S/5 Cellular Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Cellular Viewer client runs on a generic cellular phone that is connected to the hospital local area network. The Datex-Ohmeda S/5 Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 CellularViewer is not a primary alarm source. The device is for use by qualified personnel only.

Device Description

The Datex-Ohmeda S/5 Web Viewer is a supplementary monitoring application running on a generic PC that is connected to the hospital LAN, either directly or via the Internet. It is based on the World Wide Web and Java technologies, and it is intended to be used for remote viewing of real-time patient information and trends from patient monitors that are connected to the Datex-Ohmeda S/5 Network and Central. The Pocket Viewer is a Web Viewer version running on a Pocket PC PDA that is connected to the hospital LAN via wireless access within the hospital, or via a mobile connection outside the hospital. The PDA uses a standard WLAN (802,111b) or mobile connections (GSM, GPRS, HSCSD, CDMA) to gain access to the Hospital LAN and Web Server. The Cellular Viewer is a Web Viewer version running on a generic cellular phone that is connected to the hospital LAN via a mobile connection. The mobile phone uses standard mobile connections (GSM, GPRS, HSCSD) to gain access to the Hospital LAN and Web Server. The Web Viewer, Pocket Viewer and Cellular Viewer are not primary alarm sources but decisionmaking support tools that offer clinicians access to the patient data also outside the patient care area. The network architecture of the S/5 Web/Pocket/Cellular Viewer system consists of the following components:

Datex-Ohmeda S/5 Network that connects D-O monitors to one or more D O S/5 Centrals
The Hospital LAN to which the office PCs in the hospital are connected to .
. The S/5 Web Server that is connected to both of these networks
S/5 Web Viewer client programs running in desktop and laptop PCs, S/5 Pocket Viewer client . programs running in PDAs and S/5 Cellular Viewers running in generic cellular phones
. Optional VPN (virtual private network) or dial-up solutions enabling remote connection to patient monitoring data with the S/5 Web Viewer, Pocket Viewer and Cellular Viewer

The hospital is responsible for ensuring a secure and functional interface between the Datex-Ohmeda S/5 Network and the Hospital LAN, by utilizing, for example, a gateway, router, switch or firewall, as shown in the figure above. If the Web Viewer clients are not connected to a hospital Intranet, a regular hub can be used instead. Wireless LAN access points are required to connect the Pocket Viewer to the WLAN. For Cellular phones the proper subscriptions with the telephone operators are needed.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or accuracy compared to a ground truth, and details about the study design with test sets, experts, etc.).

Instead, the document is a 510(k) Premarket Notification summary for the Datex-Ohmeda S/5 Web Viewer, Pocket Viewer, and Cellular Viewer with L-WEB04 software. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (K033078), rather than presenting a performance study with specific acceptance criteria met by numerical results.

The "Summary of Nonclinical Testing" section (page 3) states that "Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications." It then lists various safety and EMC (Electromagnetic Compatibility) standards that the device was assessed against.

Here's a breakdown of the specific points you requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table with quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) derived from a clinical or analytical study, nor does it report such performance metrics. The "acceptance criteria" discussed are compliance with international and national safety and EMC standards.

Acceptance Criteria (Standards Compliance)	Reported Device Performance (Compliance Statement)
EN60950: 2000 (IEC60950 3rd edition) Product Safety	Assessed against the standard
EN 55022: 1998 (IEC-CISPR 22) Radio Frequency Interface	Assessed against the standard
EN 55024: 1998 (IEC-CISPR 24) Electromagnetic Immunity	Assessed against the standard
EN 61000-3-2:1995 + A1/A2/A14, Harmonic Currents	Assessed against the standard
EN 61000-3-3:1995, Voltage Fluctuation and Flicker	Assessed against the standard
EMC Directive 89/336/EEC (including amendments)	Assessed against the standard
Low Voltage Directive 73/23/EEC (amended by 93/68/EEC)	Assessed against the standard
ISO 14971:2000, Medical devices - Risk analysis	Assessed against the standard
IEC 60601-1-4 Medical electrical equipment. Part 1: General requirements for safety. Collateral Standard: Safety requirements for programmable medical systems.	Assessed against the standard
CAN/CSA-C22.2 No. 60950-00: Safety on Information Technology Equipment.	Assessed against the standard
UL: IEC 60950 (1999) Third Edition	Assessed against the standard
Overall Conclusion	"no new questions of safety and effectiveness"

2. Sample size used for the test set and the data provenance:

Not applicable. The document describes compliance with safety and EMC standards through "validation and verification of specifications," not through a test set of patient data.

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

Not applicable. This is not a study involving ground truth established by experts for a test set of data.

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

Not applicable.

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 MRMC study was mentioned. The device is a remote viewing application, not an AI diagnostic tool.

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

Not applicable. This device is a viewing application for physiological monitoring data, not an algorithm performing a standalone diagnostic or assistive function on its own.

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

Not applicable in the context of a performance study. The "ground truth" here is compliance with technical specifications and recognized safety/EMC standards.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence based on safety, EMC, and functional similarities to a predicate device. It does not present a clinical or analytical performance study with acceptance criteria, test sets, or expert-established ground truths as typically associated with diagnostic or AI-powered devices. The "testing" referred to is against various engineering and safety standards.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K052975" in a large, bold font. Below this, the text "Page 1 of 4" is printed in a smaller font size. The text suggests that this is the first page of a document that is four pages long, and "K052975" may be a document or identification number.

JAN 2 0 2006

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software

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 20, 2005

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

TRADE NAME:

Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software

COMMON NAME:

Remote monitoring device

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

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

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

The revised Datex-Ohmeda S/5 Web Viewer version and S/5 Pocket Viewer version and the new S/5 Cellular Viewer are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer versions (K033078) currently in distribution.

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

The Datex-Ohmeda S/5 Web Viewer is a supplementary monitoring application running on a generic PC that is connected to the hospital LAN, either directly or via the Internet. It is based on the World Wide Web and Java technologies, and it is intended to be used for remote viewing of real-time patient information and trends from patient monitors that are connected to the Datex-Ohmeda $/5 Network and Central. The Pocket Viewer is a Web Viewer version running on a Pocket PC PDA that is connected to the hospital LAN via wireless access within the hospital, or via a mobile connection outside the hospital. The PDA uses a standard WLAN (802,111b) or mobile connections (GSM, GPRS, HSCSD, CDMA) to gain access to the Hospital LAN and Web Server. The Cellular Viewer is a Web Viewer version running on a generic cellular phone that is connected to the hospital LAN via a mobile connection. The mobile phone uses standard mobile connections (GSM, GPRS, HSCSD) to gain access to the Hospital LAN and Web Server. The Web Viewer, Pocket Viewer and Cellular Viewer are not primary alarm sources but decisionmaking support tools that offer clinicians access to the patient data also outside the patient care area. The network architecture of the S/5 Web/Pocket/Cellular Viewer system consists of the following components:

Datex-Ohmeda S/5 Network that connects D-O monitors to one or more D O S/5 Centrals ◆
The Hospital LAN to which the office PCs in the hospital are connected to .
. The S/5 Web Server that is connected to both of these networks
S/5 Web Viewer client programs running in desktop and laptop PCs, S/5 Pocket Viewer client . programs running in PDAs and S/5 Cellular Viewers running in generic cellular phones
. Optional VPN (virtual private network) or dial-up solutions enabling remote connection to patient monitoring data with the S/5 Web Viewer, Pocket Viewer and Cellular Viewer

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

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

Similarities:

The indications for use for the S/5 Web Viewer is identical to the predicate.

The indications for use for the S/5 Pocket Viewer is identical to the predicate.

The indications for use for the S/5 Cellular Viewer is the same as in predicate S/5 Pocket Viewer except that the term 'generic handheld computer' has been replaced by a term 'generic mobile phone'.

The structure and functionality of the revised Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer and the new S/5 Cellular Viewer corresponds to the structure and functionality of the Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer (predicate). The basic architecture of the revised Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer and the new Cellular Viewer is the same as that of Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer (predicate).

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The revised Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer and the new S/5 Cellular Viewer can show real-time curves, numeric information, graphical and numerical trends and visual alarms from bedside monitors just like the predicate.

The physical network components used by the revised S/5 Web Viewer and S/5 Pocket Viewer and the new S/5 Cellular Viewer are the same as in the predicate.

Differences:

The following functionality has been added to the revised Datex-Ohmeda S/5 Web Viewer, S/5 Pocket Viewer and the new S/5 Cellular Viewer:

User interface changes:

A new viewer type Cellular Viewer is available .
Up to 30 concurrent Cellular Viewer users .
Entropy parameter numeric values and trends are provided ●
User specific configurations are possible through User Configuration Pages .
. User can change her/his own password
. No more support for S/5 Light Monitor trends

In addition to the functional changes, the following technical improvements have been implemented in the revised S/5 Web Viewer and S/5 Pocket Viewer:

. The new version supports standard mobile phone technology
Support for HTTPS tunneling with advanced communication security is available .
PC hardware: A new version of the PC for the Web Server computer has been . specified because manufacturing of the earlier one was discontinued

Summary:

The changes above do not effect safety and effectiveness of the system, and the new Datex-Ohmeda S/5 Web Viewer, S/5 Pocket Viewer and S/5 Cellular Viewer, described in this submission, are substantially equivalent to the predicate device.

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

Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

EN60950: 2000 (IEC60950 3rd edition) Product Safety .
EN 55022: 1998 (IEC-CISPR 22) Radio Frequency Interface �
EN 55024: 1998 (IEC-CISPR 24) Electromagnetic Immunity .
EN 61000-3-2:1995 + A1/A2/A14, Harmonic Currents .
EN 61000-3-3:1995, Voltage Fluctuation and Flicker .
EMC Directive 89/336/EEC (including amendments) .
Low Voltage Directive 73/23/EEC (amended by 93/68/EEC) .
. ISO 14971:2000, Medical devices - Risk analysis
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. 60950-00: Safety on Information Technology Equipment. .
. UL: IEC 60950 (1999) Third Edition,

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the revised Datex-Ohmeda S/5 Web Viewer version and S/5 Pocket Viewer version and the new S/5 Cellular Viewer and they are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer versions (K033078).

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2006

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

Re: K052975

Trade Name: Datex-Ohmeda S/5 Web Viewer, Pocket Viewer and Cellular Viewer with L-WEB04 software Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Monitors Network and Communication System Regulatory Class: Class II (two) Product Code: MSX Dated: December 19, 2005 Received: December 21, 2005

Dear Mr. Kent:

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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Joel C. Kent

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 (OS) 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 (240) 276-0120. 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 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.

B/Bummar 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: Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software.

Indications for use:

Indication for use for $/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for S/5 Pocket Viewer: The Datex-Ohmeda S/5 Pocket Viewer displays information received from other networked devices. It is comprised of a $/5 Web Server and S/5 Pocket Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Pocket Viewer clients. The S/5 Pocket Viewer client runs on a generic handheld computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda $/5 Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for S/5 Cellular Viewer: The Datex-Ohmeda S/5 Cellular Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Cellular Viewer client runs on a generic cellular phone that is connected to the hospital local area network. The Datex-Ohmeda $/5 Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 CellularViewer is not a primary alarm source. The device is for use by qualified personnel only.

Prescription Use (Part 21 CFR 801 Subpart D)

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)


(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K052976
	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).