(547 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 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's Tools
- -Remote View Applications
- । Pager Interface
- -Alarm history database
- -Time master functions
- -12-lead electrocardiogram (ECG) export
- Service-Oriented Device Compatibility (SDC) interface with encryption -
Infinity Gateway 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 Server facilitates the exchange of important clinical information between the Infinity/SDC protocol and existing hospital and patient care systems. The Infinity Gateway Server 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's Tools and Interface Options to create a seamless flow of information tailored to support clinical work flow.
Infinity Gateway Developer's Tools and Interface Options are licensed or "unlocked" by using option passwords that are associated with a USB license 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's 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 cost-effective software deployments and reduces the total cost of ownership.
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 Draeger Infinity Network and other hospital systems.
The provided text describes the regulatory clearance of Draeger Medical Systems, Inc.'s Infinity Gateway Suite (K203579) based on its substantial equivalence to a predicate device (K043549). This type of submission (510(k)) focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials typical of novel devices.
Therefore, the document primarily details the Device Description, Comparison of Technological Characteristics with Predicate Device, and Verification and Validation Testing necessary to establish substantial equivalence. It does not contain information about a diagnostic AI algorithm study with the typical acceptance criteria and study design details (e.g., sample sizes for test/training sets, blinding, expert adjudication, MRMC studies, ground truth establishment) that would be present in a submission for a novel AI/ML-driven diagnostic device.
The "Performance Data" section specifically states: "The verification and validation that was conducted confirmed the Infinity Gateway product performs according to intended use with no adverse effects upon other medical devices in the Infinity system to which it is connected. Testing confirmed that identified Product Risk mitigations functioned with the new code, with all test cases passing without exception." This refers to software engineering and functional integrity testing, not a diagnostic performance study as outlined in your request.
Given this, I cannot extract the specific information requested in your prompt as it pertains to a diagnostic AI study. However, I can summarize the closest relevant information from the provided text regarding the device's performance and verification:
Summary of Device Performance and Verification based on Substantial Equivalence (510(k) pathway):
The Infinity Gateway Suite (K203579) demonstrated its performance and met acceptance criteria through verification and validation testing confirming substantial equivalence to its predicate device (K043549).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) pathway for software modifications) | Reported Device Performance (from "Verification and Validation Testing" and "Conclusion" sections) |
|---|---|
| Functional Equivalence to Predicate Device | The device performs according to its intended use. Technologies (TCP/IP, HL7, ASTM, HTML, Active X, Windows DLL, TAP) are largely similar, with updated versions and added support for newer protocols (HL7 2.x, SDC). |
| No Adverse Effects on Other Medical Devices in the System | Confirmed via verification and validation testing. |
| Identified Product Risk Mitigations Functioned | All test cases passed without exception. Risk control measures are deemed adequate. |
| Compliance with Relevant Standards | Developed and tested in compliance with: ANSI AAMI ISO 14971:2019, IEEE Std 11073-10101-2019, IEEE Std 11073-10201-2018, ANSI AAMI IEC 62304:2006/a1:2016, ANSI AAMI IEC 62366-1:2015. |
| Maintenance of Intended Use | The intended use has not changed as a result of the proposed modifications. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Stated: This document describes functional and software interface testing, not a diagnostic study requiring a "test set" of patient data in the typical sense. No mention of data provenance (country of origin, retrospective/prospective) is made.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable: The "ground truth" here is the functional correctness and safety of the software and its interfaces, validated through engineering tests against specified requirements and standards, not through expert clinical interpretation of diagnostic data.
4. Adjudication Method for the Test Set:
- Not Applicable: There was no "test set" requiring clinical adjudication. Software test cases either pass or fail based on predefined expected outcomes.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No: This was not an MRMC study. The device is a data gateway and communication system, not a diagnostic AI intended to assist human readers in interpreting medical images or signals.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes (in a functional sense): The verification and validation testing confirms the standalone functional performance of the software. However, this is not a diagnostic "algorithm only" performance as would be applicable to an AI model detecting disease. The device’s function is to facilitate data viewing and exchange among existing systems.
7. The Type of Ground Truth Used:
- Software Requirements and Engineering Specifications: The "ground truth" for this clearance is the device's adherence to its functional requirements, safety specifications, and relevant industry standards. Testing confirmed that the software met its intended functional specifications and that risk mitigations were effective.
8. The Sample Size for the Training Set:
- Not Applicable: This is not an AI/ML-driven diagnostic device that undergoes training on a data set.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable: As there's no training set for an AI model, this is not relevant.
In conclusion, the provided text details a 510(k) submission for a medical device software system focused on data connectivity and exchange. The "acceptance criteria" and "study" described are in the context of software verification and validation, ensuring functional integrity and safety for its intended use, rather than a diagnostic performance study of an AI algorithm.
§ 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).