(66 days)
The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity Network™. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices.
The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in 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 Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS).
The 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 iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.
The Datex-Ohmeda 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 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 and GE products containing a network adapter for physical access to the D-O Network or to the GE Unity Network as well as software modules supporting network access.
The Datex-Ohmeda iCentral (also referred to as D-O iCentral in the related documentation) is the primary maintainer of communication between other networked devices in Datex-Ohmeda Network and is, thus, an essential part of the Datex-Ohmeda Network. The structure and functionality of the revised network corresponds to the structure and functionality of the substantially equivalent predicate device GE Datex-Ohmeda S/5 Network and iCentral '03 (510(k) number: K042771). The only addition to the predicate is that the capability to interface with GE Unity Network has been implemented this being accomplished by an additional network interface card and appropriate new software in the iCentral PC.
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 iCentral screen (central monitoring) and on the screen of another networked monitor (monitor-tomonitor communication). The source of the transferred data can be either a D-O monitor or a Unity Network monitor. In monitor-to-monitor communication the destination is always a D-O monitor.
- 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 Network.
- Storing and displaying selected waveforms over the whole patient case (Full Disclosure).
- 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, access points with antennas etc.
The provided text describes a medical device, the Datex-Ohmeda Network and iCentral '05, Sales Revision 4.3, and its 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance metrics in the way one might find for an AI/ML-driven diagnostic device.
Therefore, many of the requested fields regarding acceptance criteria, study design, ground truth, and expert evaluation cannot be directly extracted from the provided text. The submission is for a networking and central station system, not a device that generates diagnostic outputs requiring performance metrics like sensitivity, specificity, or reader improvement.
However, I can extract information related to the device's validation against standards and the general conclusions regarding its safety and effectiveness.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a network and central station system, the "acceptance criteria" are predominantly related to compliance with recognized standards for medical device safety, software, and electromagnetic compatibility, as well as demonstrating substantial equivalence to a predicate device. There are no performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy) for a diagnostic output.
| Acceptance Criteria Category | Specific Criteria (Standard/Guidance) | Reported Device Performance / Compliance Status |
|---|---|---|
| Electrical Safety | EN60950: 2000 (IEC60950 3rd edition) - Safety of information technology equipment | Assessed against this standard; "device has been thoroughly tested through validation and verification of specifications." |
| CAN/CSA-C22.2 No 60950: Information Technology Equipment | Assessed against this standard. | |
| UL60950: Information Technology Equipment | Assessed against this standard. | |
| EMC/EMI | EN 55022: 1994 (IEC-CISPR 22) - Information technology equipment Radio disturbance characteristics | Assessed against this standard. |
| EN 55024: 1998 (IEC-CISPR 24) – IT Equipment Immunity characteristics | Assessed against this standard. | |
| EMC Directive 89/336/EEC | Assessed against this standard. | |
| Risk Management | ISO 14971 - Medical Devices Application of risk management to medical devices | Assessed against this standard; "possible implications of these modifications to safety and effectiveness were analyzed with Risk Analysis and the conclusion was, that they do not compromise either safety or effectiveness." |
| Alarm Signals | EN 475 - Medical devices Electrically-generated alarm signals | Assessed against this standard. |
| ISO 9703-1, ISO 9703-2 - Anesthesia and respiratory care alarm signals | Assessed against these standards. | |
| Programmable Medical Systems | IEC 60601-1-4 - Medical electrical equipment. Part 1: General requirements for safety. Collateral Standard: Safety requirements for programmable medical systems. | Assessed against this standard. |
| Software | FDA/ODE Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005 | Assessed against this guidance. |
| FDA/ODE Guidance for the Off-The-Shelf Software Use in Medical Devices, September 9, 1999 | Assessed against this guidance. | |
| Networking | ISO/IEC 8802-3 (ANSI/IEEE 802.3), EIA/TIA-568, EIA/TIA-TSB40 - International network cabling standards | Assessed against these standards. |
| ETS 300 826 (1997-11) - Radio Wideband Systems | Assessed against this standard. | |
| Substantial Equivalence | Comparison to predicate device: GE Datex-Ohmeda S/5 Network and iCentral '03 (K042771) | "Substantially equivalent in safety and effectiveness"; "closely corresponds to the structure and functionality" of the predicate. |
Study-Specific Information
The provided document describes nonclinical testing primarily focused on compliance with various international and national standards, and internal validation/verification processes. It is not a clinical study with a test set of patient data, ground truth established by experts, or statistical performance metrics as would be typical for a diagnostic algorithm.
- Sample size used for the test set and the data provenance: Not applicable in the context of an algorithmic diagnostic study. The "testing" refers to verification and validation of the system against standards and specifications.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic algorithm is not relevant for this type of network system submission.
- Adjudication method for the test set: Not applicable.
- 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, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm for diagnostic performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device. The "ground truth" for the system's functionality would be adherence to its design specifications and compliance with the referenced technical standards.
- The sample size for the training set: Not applicable, as this is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).