(221 days)
The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
The Infinity Gateway Suite is a suite of software applications that are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:
- Server Software Health Level seven (HL7) Interface Software Options -
- -American society for testing and materials (ASTM) Stat Lab interface
- -Developer Tools
- Pager Interface -
- -Alarm history database
- -Time master functions
- -12-lead electrocardiogram (ECG) export
Infinity Gateway Suite is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.
The Infinity Gateway Suite facilitates the exchange of important clinical information between the Infinity protocol and existing hospital and patient care systems. The Infinity Gateway Suite is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer Tools and/or Interface Options to create a seamless flow of information tailored to support clinical workflow.
Infinity Gateway Developer Tools and Interface Options are licensed or unlocked by using option passwords associated with a dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway Developer Tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates software deployments.
Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Infinity Network and other hospital systems.
The subject device is compatible with Infinity Central Station Wide version VG5.0
This document is a 510(k) Premarket Notification from the FDA granting clearance for the Infinity Gateway Suite (VF9.1.1) from Draeger Medical Systems, Inc. It primarily addresses cybersecurity updates and other software improvements to an existing device.
Based on the provided text, the device is software only and does not involve AI/ML capabilities or diagnostic imaging. Therefore, most of the requested information regarding acceptance criteria, study methodologies (like multi-reader multi-case studies, standalone performance), ground truth establishment, expert adjudication, and sample sizes for training/test sets is not applicable in the context of typical AI/ML medical device submissions.
Here's a breakdown of the relevant information from the document as it pertains to the device's performance given its nature:
1. A table of acceptance criteria and the reported device performance
Since this is a software update primarily focused on cybersecurity and feature removal/modernization, traditional performance metrics like sensitivity, specificity, or accuracy (as seen in diagnostic AI devices) are not presented. The acceptance criteria relate to the successful implementation of the software updates and ensuring the device still functions as intended.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with intended use after modifications | "The verification and validation testing conducted, confirms that the Infinity Gateway Suite VF9.1.1 product performs and functions according to its intended use with no adverse effects upon other medical devices in the Infinity system to which it is connected." |
| Successful mitigation of identified product risks | "Testing confirmed that identified product risk mitigations functions with the new code." |
| All test cases meet respective requirements | "All test cases were determined to meet their respective requirements." |
| Adequacy of risk control measures for usability hazards | "All known use-related hazards pertaining to usability have been reviewed, including those beyond the primary operating functions. As a result of this review, all risk control measures identified in the risk management process are deemed adequate to further mitigate and control the risks at an acceptable level under consideration of the intended use." |
| Substantial equivalence to predicate device maintained | "The results of the Verification and Validation testing confirm that the modified software is substantially equivalent to that of the predicate device." |
| "The Infinity Gateway Suite VF9.1.1 modifications have been demonstrated to be substantially equivalent to the predicate device, Infinity Gateway Suite VF9.0..." | |
| Cybersecurity enhancements implemented successfully | Password NIST SP800-63B compliant: "Increases cybersecurity of the Gateway device." |
| Network allow listing: "Communication between authenticated devices only" "Increases cybersecurity of the Gateway device." | |
| Infinity Unicast/Multicast encryption: "Includes unicast and multicast encryption" "Increases cybersecurity of the Gateway device." | |
| Obsolete/unintended features removed without negative impact | SDC functionality removed: "This was a non-standard implementation of SDC." "These modifications have no negative impact on the safety and effectiveness of the Gateway VF9.1.1 device." |
| PatientWatch functionality removed: "PatientWatch used ActiveX, which is no longer supported by Microsoft and the removal increases cybersecurity of the Gateway device. Alarm (Visual) removed as part of PatientWatch removal." | |
| Migration to latest Microsoft SQL and Server versions | "Migrate to latest Microsoft SQL to stay current." "Migrate to latest Microsoft Server to stay current." |
| Compliance with relevant standards | The device was developed and tested in compliance with: |
- ANSI AAMI ISO 14971:2019 (Risk Management)
- ANSI AAMI IEC 62304:2015 (Software Life Cycle Processes)
- ANSI AAMI IEC 62366-1:2020 (Usability Engineering) |
2. Sample sizes used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of patient data or specific number of test cases, but the document mentions "All test cases were determined to meet their respective requirements," implying a set of defined test cases were executed.
- Data Provenance: Not applicable in the context of patient data as this is a software update for network communication and data exchange, not a device that processes or analyzes patient-derived data for diagnostic purposes. The testing is functional and performance testing of the software itself. The document does not specify country of origin for testing, nor whether it was retrospective or prospective, as these are not relevant to this type of software update.
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):
- This is not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of software. The "ground truth" here is the expected behavior and functional requirements of the software, verified through standard software V&V processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication is typically used for ambiguous cases in clinical data annotation (e.g., differentiating between expert opinions on an image). For software functional testing, results are typically binary (pass/fail) based on predefined requirements.
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:
- This is not applicable. The Infinity Gateway Suite is a data exchange and remote viewing software, not an AI/ML diagnostic or assistive device that would be used by human "readers" (e.g., radiologists, pathologists) to interpret medical images or data. Therefore, an MRMC study is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a "standalone" algorithm in a sense that it performs its functions (data exchange, remote viewing) automatically. However, "standalone performance" usually refers to the diagnostic accuracy of an AI model on its own. Since this device doesn't perform diagnoses or predictions, this concept isn't directly relevant in the typical sense for AI. Its performance is about its functionality and interoperability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This is not applicable in the clinical sense. The "ground truth" for this software is its documented functional and cybersecurity requirements, against which the software's performance is verified.
8. The sample size for the training set:
- This is not applicable. The Infinity Gateway Suite is described as a software suite with specific functionalities (HL7 interface, Pager interface, data exchange, etc.) and cybersecurity updates. It is not an AI/ML model that undergoes a "training" phase with a dataset.
9. How the ground truth for the training set was established:
- This is not applicable for the same reason as point 8.
§ 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).