(30 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 Pocket Viewer is intended to be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.
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 an 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 an 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.
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 (802.11b) or mobile connections (GSM, GPRS, HSCSD) to gain access to the Hospital LAN and Web Server. The Web Viewer and Pocket Viewer are not primary alarm sources but decision-making support tools that offer clinicians access to the patient data also outside the patient care area.
The Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software is a remote monitoring device intended for viewing or otherwise processing information from several bedside monitors or other networked devices. It is meant for consultation and remote monitoring use by qualified medical personnel. It is explicitly stated that it is not a primary alarm source.
The study presented focuses on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda S/5 Web Viewer version K023497), rather than establishing new performance acceptance criteria for a novel medical device. Therefore, a direct table of acceptance criteria with quantified performance metrics for a new device is not provided. Instead, the document outlines the device's adherence to relevant safety and performance standards.
Here's the information regarding the device's evaluation, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a submission for substantial equivalence based on modifications to an existing device, the "acceptance criteria" are primarily compliance with relevant safety and technical standards and demonstrating that the changes do not negatively impact safety or effectiveness compared to the predicate device. Direct measurable performance metrics as one might see for a diagnostic AI device are not applicable here.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device (S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software) is substantially equivalent in safety and effectiveness to the legally marketed predicate device (Datex-Ohmeda S/5 Web Viewer, K023497). This includes similar intended use, indications for use, basic technology, structure, functionality, and performance characteristics for remote viewing of patient information. | The changes to the device (user interface enhancements, support for Pocket PC PDAs, SSL encryption, enhanced licensing, automatic log-off, event logging, access control, viewing of EEG waveforms) do not affect safety and effectiveness of the system. The new device is substantially equivalent to the predicate. |
| Software Validation | Thorough testing through validation and verification of specifications. Compliance with FDA/ODE Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (May 29, 1998) and FDA/ODE Guidance for Off-The-Shelf Software Use in Medical Devices (September 9, 1999). | The device has been "thoroughly tested through validation and verification of specifications" and complies with relevant FDA/ODE software guidances. |
| Safety Standards | Compliance with relevant international and national safety standards for medical electrical equipment and IT equipment. This includes: |
- 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)
- EN 1441, Medical devices Risk analysis
- 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. 60950-00: Safety on Information Technology Equipment.
- UL: IEC 60950 (1999) Third Edition. | The device "complies with the safety standards below and is therefore safe and effective for the intended use." Verification of compliance with all listed mandatory and voluntary standards has been made. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The evaluation focuses on compliance with standards and demonstrating that software/hardware modifications do not alter safety or effectiveness, rather than a clinical performance study with a test set of patient data.
- Data Provenance: Not applicable. The submission describes functional and technical improvements to a device that displays patient data, not a device that generates or interprets diagnostic data from a patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission, as it relates to a remote viewing system's functionality and adherence to standards, not a diagnostic or AI-driven interpretive tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described in the document.
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 device is a remote monitoring viewer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an information display system with a human-in-the-loop by design (medical personnel viewing data). It does not perform standalone algorithmic interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As noted in point 3, the evaluation of this remote viewing device does not involve ground truth based on patient data, but rather verifying its functionality, safety, and adherence to technical specifications.
8. The sample size for the training set:
- Not applicable. This document describes a software and hardware update to a remote viewing system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As noted in point 8, there is no training set for an AI/ML algorithm relevant to this submission.
§ 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).