(29 days)
The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transferring data between external devices and a monitor.
The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only.
External devices are connected to the monitoring system by using small plug-in converter modules that handle the communication between the device and S/5 monitoring system. These DIS converter modules convert the data coming from the connected device to a format that can be utilized in the Datex-Ohmeda S/5 Anesthesia Monitor, Datex-Ohmeda S/5 Critical Care Monitor, Datex-Ohmeda S/5 Compact Anesthesia Monitor. Datex-Ohmeda S/5 Compact Critical Care Monitor, or Datex-Ohmeda S/5 FM. The use of a DIS system consists of making the physical connections connecting external devices to DIS and linking DIS modules together to make a complete bus. Then the DIS transfers data between a device and the S/5 monitoring system. The user can then select the source of measurement data for physiologic parameters displayed on the Datex-Ohmeda monitor. The first DIS converter module is connected to the socket at the Datex-Ohmeda S/5 monitor. In S/5 Anesthesia Monitor, and S/5 Critical Care Monitor the DIS socket is located at the rear of the monitor and in $/5 Compact Anesthesia Monitor, $/5 Compact Critical Care Monitor, and S/5 FM monitor it is located in left hand side of the monitor. Additional DIS converter modules in a system are connected to each other with the bus cable. The external device is connected to the DIS converter module with a device specific cable. Up to ten DIS converter modules can be connected in the system. The maximum number of simultaneous interfaces is ten. The maximum length of interface cable is 10 meters (33ft). The number of DIS interfaces that can be used depend on the length of the interface cables and the particular monitor used. The Device Interfacing Solution supports interfacing of the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines. The Device Interfacing Solution can interface numerical, waveform and event type of data from the external device. Alarms are not transferred. Interfaced data can be displayed on the monitor screen, trended, printed and used for record keeping purposes. Also, interfaced physiologic data is sent to the network to be viewed at the Central station monitor.
Acceptance Criteria and Study for Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01
The provided documentation describes a 510(k) premarket notification for the Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, and focuses on demonstrating substantial equivalence to a legally marketed predicate device (N-DISxxxx..00). As such, the "acceptance criteria" and "study" are framed within the context of demonstrating this equivalence rather than establishing the performance of a novel device against predefined clinical metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Equivalence to Predicate K012531) | Reported Device Performance (N-DISxxxx..01) |
|---|---|
| Intended Use: Identical intended use. | Intended Use: "The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transferring data between external devices and a monitor." This is stated to be identical to the predicate. |
| Indications for Use: Nearly identical indications for use. | Indications for Use: "The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only." Stated as "nearly identical" to the predicate. |
| Operating Principle: Same operating principle. | Operating Principle: The device converts data from external devices to a format usable by S/5 monitors and transfers it. This is stated as the "same operating principle" as the predicate. |
| Safety and Effectiveness: Same safety and effectiveness. | Safety and Effectiveness: The conclusion states "no new questions of safety and effectiveness" and that it is "substantially equivalent in safety and effectiveness" to the predicate, based on non-clinical testing. |
| Software: Essentially the same software. | Software: Stated as "essentially the same software" as the predicate. |
| User Interface: Same user interface at the monitor. | User Interface: Stated to "Have same user interface at the monitor" as the predicate. |
| Manufacturing Process: Manufactured using the same processes. | Manufacturing Process: Stated to "Are manufactured using the same processes" as the predicate. |
| Compliance with Recognized Standards: Meeting relevant electrical safety, EMC, and labeling standards. | Compliance with Recognized Standards: Assessed against and in compliance with EN 60601-1, IEC 60601-1, CAN/CSA C22.2 No. 601.1-M90, UL 2601-1, IEC 60601-1-2, EN 980, EN 1041, and EN 60529 (IPX1). |
| New Features (N-DISVENT module): Ability to transfer current clock time for synchronization with Datex-Ohmeda AiSys Carestation (only when no case open). | New Features: N-DISVENT module can transfer time from monitor to ventilator (only with Datex-Ohmeda AiSys Carestation) for time synchronization, but only when there is no case open. |
2. Sample Size Used for the Test Set and Data Provenance
The documentation does not specify a "test set" sample size or data provenance in the way one might expect for a clinical performance study of an AI/ML device. The focus is on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.
The "testing" mentioned is likely internal validation and verification activities against engineering specifications and recognized standards. No patient data (retrospective or prospective) is mentioned for a "test set" for the purpose of evaluating data transfer accuracy or clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as there is no mention of a "test set" requiring expert-established ground truth in the context of clinical performance for this device. The device's function is data transfer, not diagnostic or predictive, which typically requires expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
This section is not applicable as there is no mention of a "test set" and thus no adjudication method for establishing ground truth for such a set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human reader performance is being evaluated, often with or without AI assistance. The Datex-Ohmeda S/5 Device Interfacing Solution is a data transfer device and does not involve human interpretation of medical images or data in a way that an MRMC study would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware and software system for data transfer. Its "performance" is inherently standalone in the sense that it automatically converts and transfers data. There is no "human-in-the-loop" for the primary function of data conversion and transfer; it's a device that facilitates the display and use of data by humans, but its core function is automated.
The "study" that proves the device meets its "acceptance criteria" (i.e., substantial equivalence) is the "summary of nonclinical testing for the device" which includes:
- Validation and verification of specifications: This refers to internal testing conducted by the manufacturer to ensure the device performs as designed.
- Assessment against recognized standards: The device was tested for compliance with specific electrical safety, electromagnetic compatibility (EMC), and labeling standards (e.g., EN 60601-1, IEC 60601-1-2).
These non-clinical tests serve as the "standalone" performance evaluation, demonstrating that the device functions correctly and safely in its intended environment.
7. The Type of Ground Truth Used
For the non-clinical testing and substantial equivalence claim, the "ground truth" would be:
- Engineering Specifications: The design and functional requirements of the device itself.
- Standard Requirements: The explicit requirements outlined in the referenced electrical safety, EMC, and labeling standards.
- Predicate Device Characteristics: The known, legally marketed characteristics and performance of the predicate device (N-DISxxxx..00), against which the new device (N-DISxxxx..01) is compared for equivalence.
8. The Sample Size for the Training Set
This section is not applicable. The Datex-Ohmeda S/5 Device Interfacing Solution is a data transfer device, not an AI/ML algorithm that requires a "training set" of data to learn or develop its capabilities. Its functionality is based on pre-programmed logic for converting data formats.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as no training set is used for this device.
§ 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).