(24 days)
The Datex-Ohmeda S/5TM 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. 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/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/5TM 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 '02 (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 1.
- Datex-Ohmeda S/5 Compact Anesthesia Monitor 2.
- Datex-Ohmeda S/5 Critical Care Monitor 3.
- Datex-Ohmeda S/5 Compact Critical Care Monitor 4.
- న్. Datex-Ohmeda S/5 Light Monitor
- Datex-Ohmeda S/5 Cardiocap 5 Monitor 6.
- Datex-Ohmeda S/5 Network and Central '02, included in this 510(k) 7.
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- Datex-Ohmeda S/5 Telemetry System
The DeioRecorder for Anesthesia (formerly named as Datex-Ohmeda AS/3 Record Keener) is also related to the D-O Network as an application using the services provided by the D-O Network. 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 '01 (510(k) number: K013246). 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 Central screen (central monitoring) and on the screen of another networked monitor (monitor-to-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, repeaters, 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 '01 (510(k) number: K013246) with additional wireless LAN hardware. The Datex-Ohmeda S/5 ViewStation is a D-O 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 (also referred as S/5 TeleCentral is a computer-based system for monitoring patients using telemetry. It consists of a PC based Central Station including receivers, antenna network, and up to 16 telemetry transmitters per station. The central station supports arrhythmia monitoring, and measuring and trending of ST changes. An S/5 TeleNet Package enables connection of Telemetry central to D-O Network. The package enables transfer of ECG waveforms, ECG related parameters and arrhythmia information to the D-O Network. Also bed-to-bed services from telemetry sessions to bedside monitors are made available.
The provided text describes a Premarket Notification (510(k) Summary) for the Datex-Ohmeda S/5 Network and Central '02. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance criteria or a study proving device meeting such criteria in the way one might for a diagnostic AI device.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or explicitly stated in this type of submission. The document primarily focuses on verifying compliance with safety standards and confirming the new device functions similarly to its predicate.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" for this device is primarily tied to its safety, effectiveness, and substantial equivalence to a predicate device as regulated by the FDA's 510(k) process. The reported "performance" is largely a demonstration that it continues to meet those regulatory and functional standards, even with modifications.
| Acceptance Criteria Category | Reported Device Performance/Verification Approach |
|---|---|
| Safety and Effectiveness | "The Datex-Ohmeda S/5 Network and Central '02 complies with the safety standards below and is therefore safe and effective for the intended use." |
| "The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5 Network and Central '02 as compared to the predicate device." | |
| Substantial Equivalence | "The Datex-Ohmeda S/5 Network and Central '02 is substantially equivalent in safety and effectiveness to the Datex-Ohmeda S/5 Network and Central '01 (510(k) number: K013246)." |
| Similarities: Indications for use (mostly), structure, functionality, basic architecture, user interface, alarm functionality. Explicitly states "The wireless communication doesn't effect the functionality of the Datex-Ohmeda S/5 Network and Central." | |
| Compliance with Standards (Safety) | The device has been "thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications." Verified compliance with numerous standards, including: |
- EN60950: 1995 (IEC950 2nd edition) - Safety of information technology equipment
- EN 55022: 1994 (IEC-CISPR 22) – Information technology equipment - Radio disturbance characteristics
- EN 55024: 1998 - IT Equipment - Immunity characteristics
- 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
- UL1950: Information Technology Equipment
- ISO/IEC 8802-3 (ANSI/IEEE 802.3), EIA/TIA-568, EIA/TIA-TSB40, international network cabling standards
- ETS 300 826 (1997-11) - Radio Wideband Systems |
| Functional Equivalence | Demonstrated by describing the device's functions (e.g., "Transmission and display of measured values and alarms," "Anesthesia record keeping," "Storing and transferring of trend and record keeping data," "Printing of anesthesia records") and stating that the "structure and functionality of the revised network corresponds to the structure and functionality of the substantially equivalent predicate device." |
| New Feature Integration | The new features (Wireless LAN, updated PC hardware, increased network size to 32 Centrals/Viewstations, extended trend data continuum to 8 Centrals, wireless connection symbol) are described as not affecting the fundamental functionality, load levels, or safety. For example, "The extension doesn't affect the load level of an individual Central, since the number of connections to any given Central remains the same." and "It is an extension of the predicate functionality and does not affect the load level of Centrals." |
Study Details (as inferable from the document type)
This document is a 510(k) premarket notification for a medical device (a clinical network and central station), not a clinical trial report for an AI or diagnostic device. Therefore, it does not describe a study in the sense of a test set, ground truth, or expert review for diagnostic performance.
- Sample size used for the test set and the data provenance: Not applicable in the context of this device and submission type. The "testing" refers to verification and validation against engineering specifications and regulatory standards, not a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) 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 networking 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-only device. Its function is to facilitate data transfer and display for human users.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the sense of diagnostic performance. The "ground truth" here is compliance with technical specifications, regulatory standards, and verified functional behavior.
- The sample size for the training set: Not applicable. This device is not an AI/machine learning product 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).