(17 days)
No
The document describes a system for viewing and processing data from bedside monitors using standard web and network technologies. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision support beyond simple data display.
No
The device is described as a viewing and processing tool for information from monitors, meant for consultation and remote monitoring, and explicitly states it is not a primary alarm source or a therapeutic device. It supports decision-making by providing access to patient data but does not directly treat or diagnose.
No
The device is described as a "decision-making support tool" for viewing patient data from other monitors, not for performing diagnostic assessments itself. It explicitly states it is "not a primary alarm source."
Yes
The device is described as software running on a generic PC and utilizing existing network infrastructure. While it interacts with hardware (monitors, servers, PCs), the device itself is the software component that processes and displays data. The description focuses on the software architecture and its function.
Based on the provided text, the Datex-Ohmeda S/5 Web Viewer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- Intended Use of the S/5 Web Viewer: The intended use clearly states that the device is for "viewing or otherwise processing of information from several bedside monitors or other networked devices." It displays "real-time patient information and trends from patient monitors."
- Nature of the Data: The data being displayed comes from patient monitors, which are measuring physiological parameters directly from the patient (e.g., heart rate, blood pressure, oxygen saturation). This is not data derived from analyzing a specimen taken from the patient.
- Device Description: The description reinforces that it's a "supplementary monitor" for "remote viewing of real-time patient information and trends from patient monitors."
The S/5 Web Viewer is a device for displaying and processing data already collected by other medical devices that are monitoring the patient directly. It does not perform any analysis on biological specimens.
N/A
Intended Use / Indications for Use
The Datex-Ohmeda S/5 Web Viewer is intended to be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.
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 networked devices in 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 will 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.
Product codes
MSX
Device Description
The Datex-Ohmeda S/5 Web Viewer is a supplementary monitor 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 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 product is not a primary alarm source but a decision-making support tool that offers clinicians access to the patient data outside the patient care area.
The network architecture of the S/5 Web Viewer system consists of the following components
- Datex-Ohmeda S/5 Network that connects Datex-Ohmeda monitors to one or more Datex Ohmeda S/5 ● Centrals.
- . The Hospital LAN network to which the desktop and laptop PC's in the hospital are connected to.
- The S/5 Web Server that is connected to both of these networks that provides the S/5 Web Viewer ● clients with patient monitoring data from the D-O monitors.
- . S/5 Web Viewer client programs running in desktop and laptop PC's
- Optionally VPN (virtual private network) or dial-up solutions enabling remote connection to patient . monitoring data with the S/5 Web Viewer.
Modifications to the predicate device (Datex-Ohmeda S/5 Web Viewer, K013387) include:
PC hardware: A new version of the PC for the Web Server computer has been specified because manufacturing of the earlier one was discontinued. The requirements for the PC have remained the same. The revised version of Datex-Ohmeda S/5 Web Viewer software L-6WV02 adds the following features to the product:
- The user can freeze and print the real-time data of the selected patient. ●
- The user can print the numerical trends of the selected patient. .
- . Netscape Navigator browser support has been included in addition to Internet Explorer.
- The previous S/5 Web Viewer was an applet that executed inside the web browser. The revised version ● is an application that is browser independent.
- . Support for optional VPN (virtual private network) or dial-up solutions has been added.
- The number of S/5 Centrals the Web Viewer can connect to has been increased from 4 to 8. .
- System administration software has been improved. ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel only / in the hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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4 2002 NOV
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Image /page/0/Picture/2 description: The image is a black and white logo. The logo is a circle with a white letter D inside. There is a small square in the upper right corner of the circle, resembling a camera flash.
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 Web Viewer with L-6WV02 software
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. Joel Kent
DATE:
October 12, 2002
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda S/5 Web Viewer with L-6WV02 software
COMMON NAME:
Remote monitoring device
CLASSIFICATION NAME:
The following Class II classification appears applicable:
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 revised Datex-Ohmeda S/5 Web Viewer with L-6WV02 software version is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer version (K013387).
1
DEVICE DESCRIPTION as required by 807.92(a)(4)
The intended use for the modified device Datex-Ohmeda S/5 Web Viewer with L-6WV02 software is the same as the predicate, Datex-Ohmeda S/5 Web Viewer (K013387). There has been no change to the basic technology from the predicate. The Datex-Ohmeda S/5 Web Viewer is a supplementary monitor 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 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 product is not a primary alarm source but a decision-making support tool that offers clinicians access to the patient data outside the patient care area.
The network architecture of the S/5 Web Viewer system consists of the following components
- Datex-Ohmeda S/5 Network that connects Datex-Ohmeda monitors to one or more Datex Ohmeda S/5 ● Centrals.
- . The Hospital LAN network to which the desktop and laptop PC's in the hospital are connected to.
- The S/5 Web Server that is connected to both of these networks that provides the S/5 Web Viewer ● clients with patient monitoring data from the D-O monitors.
- . S/5 Web Viewer client programs running in desktop and laptop PC's
- Optionally VPN (virtual private network) or dial-up solutions enabling remote connection to patient . monitoring data with the S/5 Web Viewer.
Modifications to the predicate device (Datex-Ohmeda S/5 Web Viewer, K013387) include:
PC hardware: A new version of the PC for the Web Server computer has been specified because manufacturing of the earlier one was discontinued. The requirements for the PC have remained the same. The revised version of Datex-Ohmeda S/5 Web Viewer software L-6WV02 adds the following features to the product:
- The user can freeze and print the real-time data of the selected patient. ●
- The user can print the numerical trends of the selected patient. .
- . Netscape Navigator browser support has been included in addition to Internet Explorer.
- The previous S/5 Web Viewer was an applet that executed inside the web browser. The revised version ● is an application that is browser independent.
- . Support for optional VPN (virtual private network) or dial-up solutions has been added.
- The number of S/5 Centrals the Web Viewer can connect to has been increased from 4 to 8. .
- System administration software has been improved. ●
INTENDED USE as required by 807.92(a)(5)
Intended use:
The Datex-Ohmeda S/5 Web Viewer is intended to be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.
Indications for use:
The Datex-Ohmeda S/S 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 networked devices in 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 will 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.
2
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The revised Datex-Ohmeda S/5 Web Viewer with L-6WV02 software version is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer version (K013387) currently in distribution.
Similarities:
The indications for use are the same as in the predicate.
The structure and functionality of the revised Datex-Ohmeda S/5 Web Viewer corresponds to the structure and functionality of the Datex-Ohmeda S/5 Web Viewer (predicate). The basic architecture of the revised Datex-Ohmeda S/5 Web Viewer is the same as that of Datex-Ohmeda S/5 Web Viewer (predicate). The revised Datex-Ohmeda S/5 Web 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 and the PC hardware components used by the revised S/5 Web Viewer are the same as in the predicate.
Differences:
The following functionality has been added to the revised Datex-Ohmeda S/5 Web Viewer:
- The user can freeze and print the real-time data of the selected patient 0
- The user can print the numerical trends of the selected patient o
- The number of S/5 Centrals the Web Viewer can connect to has been increased from 4 to o 8. It is possible to view only one monitor at a time.
In addition to the functional changes, the following technical improvements have been implemented in the revised S/5 Web Viewer:
- Optional VPN (virtual private network) or dial-up solutions enabling remote connection o to patient monitoring data with the S/5 Web Viewer is now supported.
- Microsoft Internet Explorer and Netscape Navigator browsers are supported by the new o Web Viewer version. The previous version supported the Internet Explorer only.
- Microsoft Windows 95/98/ME/NT4.0/2000/XP and Mac OS X operating systems are o supported. The previous version supported Microsoft operating systems only.
- The previous S/5 Web Viewer was an applet that executed inside the web browser. The ಂ revised version is an application that is browser independent .
- The web server software has been changed to a pure Java web server. The previous o version used Microsoft IIS server software.
- The system administration has been improved. 0
In summary, the new Datex-Ohmeda S/5 Web Viewer with L-6WV02 software, described in this submission is substantially equivalent to the predicate device.
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
The Datex-Ohmeda S/5 Web Viewer with L-6WV02 software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made:
- EN60950: 2000 (IEC60950 3rd edition) Product Safety ●
3
- EN 55022: 1998 (IEC-CISPR 22) Radio Frequency Interface .
- EN 55024: 1998 (IEC-CISPR 24) -- Electromagnetic Immunity .
- IEC 61000-3-2, Harmonic Currents (IEC 61000-3-2) .
- IEC 61000-3-3, Voltage Fluctuation and Flicker (IEC-61000-4-2) .
- EN 1441, Medical devices Risk analysis ●
- . IEC 60601-1-4
- CAN/CSA-C22.2 No 950-95: Safety on Information Technology Equipment, Including Electrical . Business Equipment
- UL1950: Information Technology Equipment Including Electrical Business Equipment .
- ISO/IEC 8802-3 (ANSI/IEEE 802.3), EIA/TIA-568, EIA/TIA-TSB40, international network cabling ● standards
Conclusion:
The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5 Web Viewer with L-6WV02 software as compared to the predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH · HUMAN SERVICES · USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines representing hair or clothing. The profiles are black, and the background is white.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Image /page/4/Picture/4 description: The image shows the date November 4, 2002. The month is abbreviated to NOV. The day is the number 4. The year is 2002.
Datex Ohmeda c/o Mr. Joel C. Kent Manager, Ouality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492
Re: K023497
Trade Name: Datex-Ohmeda S/5 Web Viewer with L-6WV02 Software Regulation Name: Cardiac Monitor Regulation Number: 21 CFR 870.2300 Regulatory Class: Class II (two) Product Code: MSX Dated: October 16, 2002 Received: October 18, 2002
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. Iisting 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.
5
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nalgetta
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: Datex-Ohmeda S/5 Web Viewer with L-6WV02 software Indications For Use:
The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of an S/5 Web Server and S/5 Web Viewer clients.
The Datex-Olumeda S/5 Web Server maintains and coordinates the network connections between the networked devices in 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 will 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
Review Number: K023497