Infinity Gateway Suite
Device Facts
| Record ID | K233834 |
|---|---|
| Device Name | Infinity Gateway Suite |
| Applicant | Draeger Medical Systems, Inc. |
| Product Code | MSX · Cardiovascular |
| Decision Date | Jul 12, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
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.
Device Story
Infinity Gateway Suite is a client-server software application facilitating data exchange between Infinity Network and hospital LAN. Server runs on Windows Server; connects to hospital network and Infinity Network. Enables remote viewing of patient data; supports HL7 interface, ASTM Stat Lab interface, pager interface, alarm history database, time master functions, and 12-lead ECG export. Licensed via physical dongle with option passwords. Developer tools (WinAccess API) allow custom application development for research or downstream systems. Deployed via virtual machine technology. Provides clinicians with integrated patient data for decision-making and continuity-of-care support. Not for primary monitoring or independent diagnosis.
Clinical Evidence
Bench testing only. No clinical data. Verification and validation testing confirmed that the software performs according to intended use, risk mitigations function correctly, and all test cases met requirements.
Technological Characteristics
Software-only device; no physical form. Operates on Windows Server 2022 with Microsoft SQL 2022. Connectivity via hospital LAN and Infinity Network. Complies with ANSI AAMI ISO 14971:2019 (risk management), ANSI AAMI IEC 62304:2015 (software life cycle), and ANSI AAMI IEC 62366-1:2020 (usability).
Indications for Use
Indicated for clinicians requiring remote viewing of patient data and exchange of clinical/administrative information between Infinity Network and hospital networks. Not intended for primary patient monitoring or independent diagnosis.
Regulatory Classification
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.
Predicate Devices
- Infinity Gateway Suite, VF9.0 (K203579)
Submission Summary (Full Text)
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July 12, 2024
Draeger Medical Systems, Inc. Megan Brewster Regulatory Affairs Specialist 6 Tech Dr Andover, Massachusetts 01810
Re: K233834
Trade/Device Name: Infinity Gateway Suite Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: June 7, 2024 Received: June 10, 2024
Dear Megan Brewster:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This clearance applies to the version of the device that is intended to be used with Infinity Central Station Wide version VG5.0.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly N. Crowley -S
For:
Jennifer Kozen Assistant Director
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Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K233834
Device Name Infinity Gateway Suite
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810-2434
# 510(k) SUMMARY
#### I. Submitter:
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810, U.S.A.
Contact Person: Megan Brewster Senior Regulatory Affairs Specialist Draeger Medical Systems, Inc. Phone: 978-447-2410 E-mail: megan.brewster(a)draeger.com July 10, 2024
#### II. Device
## Names / Common Names / Classification Names:
| Common Name: | Computers and Software, Medical |
|----------------------|---------------------------------------------------------|
| Trade Name: | Infinity® Gateway Suite |
| Classification Name: | System Network and Communication Physiological Monitors |
| Product Code: | MSX |
| Subsequent Code: | LNX |
| Regulatory Class: | II |
| Regulation Number: | §870.2300 |
#### III. Predicate Device
The Infinity® Gateway Suite, VF9.0, cleared via K203579 on June 7, 2022.
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#### IV. Device Description
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
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#### V. Intended Use
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 and its options are not intended to be used for primary patient monitoring or independent diagnosis.
#### VI. Indications for Use
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.
#### VII. Comparison of Technological Characteristics with Predicate Device
The Infinity Gateway Suite VF9.1.1 device, like its predicate, is a software only device; it has no physical form. The intended use, performance and technological characteristics of the subject device are substantially equivalent to the predicate device.
Some device modifications were made to mitigate vulnerabilities by eliminating device features as outlined in the "Significant Modifications Introduced in this Submission" section below. These modifications have no negative impact on the safety and effectiveness of the Gateway VF9.1.1 device. See the Table below for the comparison between the predicate device, Infinity Gateway VF9.0, and the subject device, Infinity Gateway VF9.1.1.
| Infinity® Gateway Suite VF9.0 and VF9.1.1 Comparison | | | |
|-------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------|
| Device Attributes | Infinity® Gateway Suite VF9.0<br>Predicate Device (K203579) | Infinity® Gateway Suite<br>VF9.1.1 Subject Device | Explanation of Changes |
| Microsoft SQL<br>Compatible | 2017 | 2022 | Migrate to latest Microsoft SQL to<br>stay current. |
| Microsoft Server | 2016 | 2022 | Migrate to latest Microsoft Server<br>to stay current. |
| Service-Oriented<br>Device Connectivity<br>(SDC) – OUS only | Includes SDC functionality | SDC functionality removed | This was a non-standard<br>implementation of SDC. |
| Infinity<br>Unicast/Multicast<br>encryption | N/A | Includes unicast and multicast<br>encryption | Increases cybersecurity of the<br>Gateway device. |
| Passwords | No password complexity<br>requirements | Password NIST SP800-63B<br>compliant | Increases cybersecurity of the<br>Gateway device. |
| Network allow listing | N/A | Communication between<br>authenticated devices only | Increases cybersecurity of the<br>Gateway device. |
| PatientWatch | PatientWatch support | PatientWatch functionality<br>removed | PatientWatch used ActiveX, which<br>is no longer supported by |
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| Infinity® Gateway Suite VF9.0 and VF9.1.1 Comparison | | | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Attributes | Infinity® Gateway Suite VF9.0<br>Predicate Device (K203579) | Infinity® Gateway Suite<br>VF9.1.1 Subject Device | Explanation of Changes |
| | | | Microsoft and the removal<br>increases cybersecurity of the<br>Gateway device. Alarm (Visual)<br>removed as part of PatientWatch<br>removal. |
| Alarm Grade / State | PatientWatch, Pager, WinAccess<br>API, FileAccess, and HL7 ACM<br>allow for accessing alarm grade<br>and state. | Pager, WinAccess API, and<br>FileAccess allow for accessing<br>alarm grade and state. | PatientWatch and HL7 ACM<br>removed from VF9.1.1. Alarm<br>Grade/State still available through<br>Pager, WinAccess API, and<br>FileAccess |
#### VIII. Significant Modifications Introduced in this Submission
Cybersecurity updates and other software improvements in Infinity Gateway VF9.1.1. See the Table above for detailed information on the modifications introduced in Infinity Gateway VF9.1.1.
#### IX. Performance Data
# Verification and Validation Testing:
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. Testing confirmed that identified product risk mitigations functions with the new code. All test cases were determined to meet their respective requirements.
Also, 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. The results of the Verification and Validation testing confirm that the modified software is substantially equivalent to that of the predicate device.
Biocompatibility: The proposed Infinity Gateway Suite VF9.1.1 is a software only device and has no physical form. Therefore, biocompatibility requirements are not applicable.
Sterilization: Sterilization and Shelf-Life: The proposed Infinity Gateway Suite VF9.1.1 is a software only device and has no physical form. Therefore, sterilization and shelf-life requirements are not applicable.
## Standards/Compliance Testing:
The Infinity Gateway Suite software modifications have been tested and developed in compliance with the following standards:
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- ANSI AAMI ISO 14971: 2019 Medical devices Applications of risk management to ● medical devices
- . ANSI AAMI IEC 62304:2015
- Medical device software Software life cycle processes [Including Amendment 1 . (2016)]
- ANSI AAMI IEC 62366-1:2020 Medical devices Part 1: Application of usability . engineering to medical devices
#### X. Conclusion
The Infinity Gateway Suite VF9.1.1 modifications have been demonstrated to be substantially equivalent to the predicate device, Infinity Gateway Suite VF9.0, which was cleared under K203579 on June 7, 2022. The intended use of the Infinity Gateway Suite as described in the product labeling, although slightly modified, does not change the actual intended use of the device. The intended use statement has been modified for clarification purposes only, not as a result of the proposed device modifications. Verification and Validation results for the proposed modifications support substantial equivalence to the predicate device.
