(43 days)
The Datex-Ohmeda S/5TM Network and iCentral transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several iCentrals. 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/5TM iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Datex-Ohmeda monitor network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda S/5TM Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS).
The Datex-Ohmeda S/5TM iCentral can be used for remote monitor management. storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.
The Datex-Ohmeda S/5TM 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 510(k) 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:
- Datex-Ohmeda S/5 Anesthesia Monitor
- Datex-Ohmeda S/5 Compact Anesthesia Monitor
- Datex-Ohmeda S/5 Critical Care Monitor
- Datex-Ohmeda S/5 Compact Critical Care Monitor
- Datex-Ohmeda S/5 Light Monitor
- Datex-Ohmeda S/5 Cardiocap 5 Monitor
- Datex-Ohmeda S/5 WebViewer
- Datex-Ohmeda S/5 Network and Central, included in this 510(k)
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. As a consequence, adding new types of Datex-Ohmeda devices to Datex-Ohmeda Network does not in any way affect the safety and effectiveness of Datex-Ohmeda Network or Central, if the devices are using the same protocol and the same design principles are followed as in the currently networked Datex-Ohmeda devices. The Datex-Ohmeda S/5 iCentral (also referred to as D-O iCentral 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 '02 (510(k) number: K022507). 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:
Transmission and display of measured values and alarms in the Datex-Ohmeda S/5 iCentral screen (central monitoring) and on the screen of another networked monitor (monitor communication).
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.
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, access points with antennas etc. The networking hardware is similar to the networking hardware of the substantially equivalent predicate device Datex-Ohmeda Network and Central '02 (510(k) number: K022507).
The provided text is a 510(k) Premarket Notification for the Datex Ohmeda S/5 Network and Central (iCentral) '03 with L-NET03 Software. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria, device performance metrics, or details found in a clinical or standalone performance study.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Safety and Effectiveness | Substantially equivalent to predicate device (Datex-Ohmeda S/5 Network and Central '02, K022507) in safety and effectiveness. | The device complies with numerous safety standards (EN60950, EN 55022, EN 55024, EMC Directive, Low Voltage Directive, EN 1441, EN 475, ISO 9703-1, ISO 9703-2, IEC 60601-1-4, CAN/CSA-C22.2 No 950, UL 1950, FDA/ODE Guidance for Software, ISO/IEC 8802-3, ETS 300 826). Through validation and verification of specifications. | The primary acceptance criterion is substantial equivalence to a previously cleared device. The "performance" is demonstrated by adherence to relevant safety and electromagnetic compatibility standards and internal validation/verification. No specific clinical performance metrics (e.g., accuracy, sensitivity, specificity) are provided as this is a network system, not a diagnostic device. |
| Intended Use Equivalence | Intended use is the same as the predicate, with minor stated modifications ("reviewing" expressed, S/5 ViewStation removed). | "The indications for use are the same as in the predicate except that "reviewing" has been expressed in the statement and the S/5 ViewStation has been removed." | The intended use is considered met if it aligns with the predicate device. |
| Technological Characteristics | Structure and functionality closely corresponds to the predicate; basic architecture is the same. User interface uses the same basic functionality. Most alarm functionalities are identical. | The basic architecture, structure, functionality, and core user interface functionalities are stated to be the same as the predicate. | Differences are acknowledged (new UI, new parameters, improved features) but are deemed not to raise new questions of safety or effectiveness. |
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. This submission does not describe a clinical study with a test set of patient data. The device is a network and central monitoring system, not a diagnostic or treatment device that processes patient-specific outcome data in the context of a clinical trial. The testing involved compliance with engineering, electrical, and software standards.
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. There is no mention of experts establishing a ground truth for a test set in the context of patient data, as this device primarily deals with data transmission and display, ensuring network functionality and safety.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set data requiring adjudication is mentioned.
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 network and central monitoring system. It does not involve AI or human readers for diagnostic interpretation, nor does it present data from an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a system for networked medical devices, not a standalone algorithm with performance metrics like sensitivity or specificity. Its "performance" is based on its ability to meet engineering and safety standards for data transmission and display.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The concept of "ground truth" as typically used in medical device studies (e.g., for diagnostic accuracy) does not apply to this network and central monitoring system. The "truth" in this context is whether the system functions as designed and adheres to established technical and safety standards.
8. The sample size for the training set
- Not Applicable. This submission does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth is mentioned.
§ 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).