(74 days)
The 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 Centrals. 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 Datex-Ohmeda S/5™ Central maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Datex-Ohmeda monitor network. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda S/5™ Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS).
The Datex-Ohmeda S/5™ Central can be used for remote monitor management, storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.
The Datex-Ohmeda S/5™ ViewStation can be used for remote monitor management, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.
The 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.
The 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 510k 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:
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Datex-Ohmeda S/5 Anesthesia Monitor
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Datex-Ohmeda S/5 Compact Anesthesia Monitor
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Datex-Ohmeda S/5 Critical Care Monitor
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Datex-Ohmeda S/5 Compact Critical Care Monitor
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Datex-Ohmeda S/5 Light Monitor
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Datex-Ohmeda S/5 Cardiocap 5 Monitor
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Datex-Ohmeda S/5 Network and Central, included in this 510(k)
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Datex-Ohmeda S/5 Telemetry System
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 Datex-Ohmeda S/5 Network and Central itself due to a new type of networked device.
The Datex-Ohmeda S/5 Central (also referred to as D-O Central in the related 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 (510(k) number: K000647).
The 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:
O Transmission and display of measured values and alarms in the Datex-Ohmeda S/5 Central screen (central monitoring) and on the screen of another networked monitor (monitor-to-monitor communication).
O 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 Datex-Ohmeda S/5 Network.
D 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, etc. The networking hardware is similar to the networking hardware of the substantially equivalent predicate device Datex-Ohmeda Network and Central (510(k) number: K000647).
The Datex-Ohmeda S/5 ViewStation is a D-0 Central version that can show real-time curves and numeric information from any monitor residing in the Datex-Ohmeda Network. It also allows printing to laser printer or recording to a strip-chart recorder. The Datex-Ohmeda S/5 ViewStation does not store patient data, or provide any other network services than display and printing services. The ViewStation uses the same hardware and a subset of the software used by the main Central.
The Datex-Ohmeda S/5 Telemetry System Network is a computer-based system for monitoring patients using telemetry. It consists of a PC based Central Station including moments patients assurence as and up to 16 telemetry transmitters per station. The central station supports arrhythmia monitoring, and measuring and trending of ST changes. An Station Jupports arres has been developed to enable connection of Telemetry central to D-O STS TeleNot I ackage enables transfer of ECG waveforms, ECG related parameters and archythmia information to the D-O Network. Also bed-to-bed services from telemetry sessions to bedside monitors are made available.
The new version of Datex-Ohmeda S/5 Network and Central adds the following features: Commercial hardware: The display driver is a commercial board instead of D-O proprietary boards. The proprietary keyboard is not used anymore, instead there is a commercial keyboard with dedicated "EasyAccess" keys
O User Interface is now mouse controlled in addition to keyboard controlled O Numerical and graphical trends have been added
O Alarm management functionality has been extended: remotely silencing of bedside alarms and changing alarm limits from Datex-Ohmeda S/5 Central or ViewStation have been added
□ Monitor disconnection warning on Central has been added
□ Possibility to start a network recorder from a bedside monitor has been added D TeleNet Package to enable connection of Datex-Ohmeda S/5 Telemetry System to D-O Network
The provided text is a 510(k) summary for the Datex-Ohmeda S/5 Network and Central '01. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way often seen for novel AI/ML devices. Therefore, many of the requested categories of information are not directly available or applicable in this type of submission.
Here's an analysis of what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense for a 510(k) substantial equivalence submission for this type of device. The document does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and then report performance against them. Instead, it demonstrates compliance with safety standards and outlines technological similarities and differences to a predicate device to argue for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (or not reported for clinical evaluation). The submission describes non-clinical testing focused on compliance with safety standards (e.g., EN60950, EN 55022, IEC 801-3, EN 1441). These standards involve tests for electrical safety, electromagnetic compatibility, risk analysis, and alarm signals. These types of tests do not rely on a "test set" of patient data in the way an AI/ML diagnostic algorithm would. No clinical test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As there's no clinical "test set" of patient data for a diagnostic algorithm, there's no requirement or mention of experts establishing a ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication 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 a system for networking and central monitoring of physiological monitors, not a diagnostic AI device intended to assist human readers in interpreting clinical cases. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a network and central station for existing physiological monitors, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No clinical ground truth is established or used for the evaluation presented in this 510(k) summary. The "truth" in this context comes from adherence to established engineering and safety standards.
8. The sample size for the training set
- Not Applicable. As this is not an AI/ML device relying on a training set of data for algorithm development, no training set size is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No training set ground truth applies.
Summary of Device Evaluation in the Document:
The evaluation for the Datex-Ohmeda S/5 Network and Central '01 is primarily a non-clinical safety and performance evaluation demonstrating compliance with a list of mandatory and voluntary standards:
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Compliance with Safety Standards:
- EN60950: 1995 (IEC950 2nd edition) - Safety of information technology equipment
- EN 55022: 1994 (IEC-CISPR 22) - Information technology equipment Radio disturbance characteristics
- IEC 801-3, IEC 801-4 - Electromagnetic compatibility Generic immunity standard
- 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
- CAN/CSA-C22.2 No 950 - 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
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Software Validation and Verification of Specifications: Mentioned as part of the thorough testing, but without specific test results or methodologies detailed in this summary.
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Environmental Tolerance Testing: Mentioned as part of the thorough testing.
The conclusion drawn from this non-clinical testing is that the device "complies with the safety standards below and is therefore safe and effective for the intended use" and that "there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5 Network and Central as compared to the predicate device."
In essence, the "acceptance criteria" are compliance with the listed international and national safety and performance standards for medical electrical equipment and information technology equipment, and the "study" is the battery of tests conducted to ensure this compliance, along with a comparison to a legally marketed predicate device (K000647) to demonstrate substantial equivalence.
§ 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).