(17 days)
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.
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.
This document is a 510(k) Premarket Notification for the Datex-Ohmeda S/5 Web Viewer with L-6WV02 software. It focuses on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda S/5 Web Viewer, K013387) rather than presenting a study with specific acceptance criteria and performance metrics for a novel medical AI device.
Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document, as this submission predates widespread AI in medical devices and focuses on software and hardware updates for a remote monitoring system.
Here's an analysis based on the provided text, indicating where information is present or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to predicate device (K013387) in safety and effectiveness. | "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." |
| Compliance with Standards | Compliance with specific mandatory and voluntary safety and EMC standards. | "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." |
| Standards listed include: EN60950, EN 55022, EN 55024, IEC 61000-3-2, IEC 61000-3-3, EN 1441, IEC 60601-1-4, CAN/CSA-C22.2 No 950-95, UL1950, ISO/IEC 8802-3. | ||
| Functional Equivalence/Performance | Display real-time curves, numeric information, graphical/numerical trends, and visual alarms from bedside monitors as reliably as the 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." |
| System Stability/Reliability (Implied by software validation) | Software validation demonstrates no new questions of safety and effectiveness, implying stable and reliable operation despite added features. | "The device has been thoroughly tested including... software validation and verifications." |
| "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." | ||
| Hardware Compatibility | Requirements for the PC hardware remain the same as the predicate. | "The requirements for the PC have remained the same." (Referencing the new web server PC). |
| Increased S/5 Centrals Connection | Ability to connect to up to 8 S/5 Centrals (increase from 4). | "The number of S/5 Centrals the Web Viewer can connect to has been increased from 4 to 8." |
| Printing Functionality | Ability to freeze and print real-time data and numerical trends. | "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." | ||
| Browser/OS Support | Broader compatibility with browsers (Netscape Navigator in addition to Internet Explorer) and operating systems (Mac OS X in addition to Microsoft OS). | "Netscape Navigator browser support has been included in addition to Internet Explorer." |
| "Microsoft Internet Explorer and Netscape Navigator browsers are supported by the new Web Viewer version." | ||
| "Microsoft Windows 95/98/ME/NT4.0/2000/XP and Mac OS X operating systems are supported." | ||
| Remote Connection Support | Support for optional VPN or dial-up solutions. | "Support for optional VPN (virtual private network) or dial-up solutions has been added." |
| Application Type | Transition from applet to browser-independent application. | "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." |
2. Sample size used for the test set and the data provenance
This document does not describe a clinical study with a "test set" in the context of an AI device's performance evaluation. The testing described is primarily non-clinical: electrical safety, EMC, mechanical/environmental tolerance, and software validation. Therefore, sample size and data provenance are not applicable in the way they would be for an AI-driven diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a diagnostic test set is described as this is a software update for a remote physiological monitoring viewer.
4. Adjudication method for the test set
Not applicable. No diagnostic test set or adjudication process 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
Not applicable. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a viewer for human use to monitor patient data; it is not a standalone algorithm performing automated analysis or diagnosis. Its function is to display information for qualified medical personnel.
7. The type of ground truth used
Not applicable. The validation is against engineering and software standards, functional requirements, and substantial equivalence to a predicate, not against a clinical "ground truth" for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This document describes a software and hardware update for a remote monitoring system, not an AI algorithm trained on a dataset.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).