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 Description

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.

AI/ML Overview

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.

Summary

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Draeger Medical Systems, Inc. Eileen Boyle Manager, Regulatory Affairs 6 Tech Drive Andover, Massachusetts 01810 May 17, 2024

Re: K203579

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

Dear Eileen Boyle:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 7, 2022. Specifically, FDA is updating this SE letter as an administrative correction. A second product code, LNX, was inadvertently included.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LCDR Stephen Browning, OHT2: Office of Cardiovascular Devices, 240-402-5241, Stephen.Browning@fda.hhs.gov.

Sincerely,

Stephen C. Browning -S

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "U.S. Food & Drug Administration" in blue text.

June 7, 2022

Draeger Medical Systems, Inc. Eileen Boyle Manager, Regulatory Affairs 6 Tech Drive Andover, Massachusetts 01810

Re: K203579

Trade/Device Name: Infinity Gateway Suite Regulation Number: 21 CFR 870.2300 Regulation Name: System, Network and Communication, Physiological Monitors Regulatory Class: Class II Product Code: MSX, LNX Dated: June 1. 2022 Received: June 2, 2022

Dear Eileen Boyle:

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 (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 located 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.

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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director 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) K203579

Device Name Infinity Gateway Suite

Indications for Use (Describe)

Indications for Use:

Intended Use

Intended Operator

The Infinity Gateway software application is intended for use by Healthcare Providers, ie. Physicians, Nurses, and Technicians.

Intended Patient Population

The Infinity Gateway software application is not intended to be connected to patients.

Intended Use Environment

The infinity Gateway software application is intended for use in a healthcare environment.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ 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 USA

Contact Person: Eileen M. Boyle Manager, Regulatory Affairs Draeger Medical Systems, Inc. Phone: 781-439-8120 E-mail:eileen.boyle@draeger.com November 19, 2021 - Date Prepared

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:	§870.1025

III. Predicate Device

The Infinity® Gateway Suite, VF4 K043549 cleared on January 21, 2005.

510(k)No.	Trade Name	Manufacturer	Product Code/Common Name	RegulationNumber
K0435491/21/2005	InfinityGateway Suite(VF4)	Draeger MedicalSystems, Inc.	MSX - System, Network andCommunication, PhysiologicalMonitorsLNX - Computers and Software,Medical	21CFR870.1025

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Device Description IV.

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 -

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technology, which facilitates cost-effective software deployments and reduces the total cost of ownership.

V. Indications for Use / Intended Use

Intended Use

Intended Operator

The Infinity Gateway software application is intended for use by Healthcare Providers, ie. Physicians, Nurses, and Technicians.

Intended Patient Population

The Infinity Gate4way software application is not intended to be connected to patients.

Intended Use Environment

The infinity Gateway software application is intended for use in a healthcare environment.

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VI. Comnarison of Technological Characteristics with Predicate Device

The intended use, indications for use, performance and technological characteristics are substantially equivalent to the predicate device.

A summary of the main changes compared to the predicate device are listed in the comparison table below:

Attribute	Predicate DeviceInfinity Gateway SuiteK043549- VF4	Subject DeviceInfinity Gateway Suite510(k)#K203579 – VF9.0	Explanation of Similaritiesand Differences
Manufacturer	Draeger MedicalSystems, Inc.	Draeger Medical Systems,Inc.	Same
510(k) Number	K043549	K203579	-
Model Number	MS16076	MS40046	-
Intended Use	The Infinity Gatewaysoftware applications areintended to provideclinicians with thecapability of viewingpatient data remotely viathe Infinity Network andfor the data exchange ofselect clinical andadministrativeinformation between theInfinity Network and thehospital network.	The Infinity Gatewaysoftware applications areintended to provide clinicianswith the capability ofviewing patient dataremotely via the InfinityNetwork and for the dataexchange of select clinicaland administrativeinformation between theInfinity Network and thehospital network.	Same, no change since VF4
Update the supportedversion MicrosoftSQL to 2017	2008	2017	2008 will no longer be asupported version
Incorporate supportfor Microsoft SQL2017 and MicrosoftServer OperatingSystem 2016	Windows NT 4.0,Windows 2000 orWindows XP	New feature in VF9.0Support Microsoft SQL 2017Express and Standard.Support Microsoft ServerOperating System 2016 forthe server application.	Windows NT 4.0, Windows2000, Windows XP will nolonger be supportedversions.
Make the Service-Oriented DeviceCompatibility (SDC)a locked option withencryption	Not part of VF4software.	SDC defines acommunication architectureto establish distributedsystems of medical devicesin clinical environments.	This new feature is for usewith Draeger SDC devices.This license option allowsfor interoperability andconnectivity with theintegrated ClinicalAssistance Package which
Attribute	Predicate DeviceInfinity Gateway SuiteK043549 - VF4	Subject DeviceInfinity Gateway Suite510(k)#K203579 - VF9.0	Explanation of Similaritiesand Differences
			consists of an anesthesiaworkstation, a patientmonitoring system and theHospital InformationSystem:Infinity Gateway softwareVF9.0Infinity Acute Care System(IACS) patient monitor withsoftware version VG7.1Connectivity ConverterCC300 with softwareversion 1.1Perseus A500 AnesthesiaMachineBabylog VN500Evita Infinity V500Ventilator
Redundant ServerOption	Not part of VF4software.	An administrator performsthe switchover manually bypowering up or enabling theGateway service on theredundant server.	Gateway supports the use ofan optional redundantserver. This is a licensedoption. It allows a separateserver to be configured inadvance which cantemporarily replace a failedGateway server.
IHE/HL7 AlarmInterface LockedOption (For SDCOnly)	Not part of VF4software.	New feature in VF9.0The IHE/HL7 AlarmCommunication interfaceexports Alarm data fromdevices on the SDC networkto a CIS for long termstorage and record keeping.The interface support IEEE11073 output and can beconfigured to be IHE PCDACM Compliant.	The IHE/HL7 alarmcommunicationmanagement interface isonly available for use withSDC devices.
Attribute	Predicate DeviceInfinity Gateway SuiteK043549- VF4	Subject DeviceInfinity Gateway Suite510(k)#K203579 – VF9.0	Explanation of Similaritiesand Differences
Intended Population	The communicationnetwork and centralmonitoring device arenot connected to patients.	The communication networkand central monitoringdevice are not connected topatients.	Same
Intended Environment	A healthcare facilitywhere healthcareprofessionals providepatient care.	A healthcare facility wherehealthcare professionalsprovide patient care.	Same
Gateway PagerAccess application	Yes	Yes	Same
Global SessionManager	Yes	No	Global Session Manager isno longer supported. Nochange to intended use.
Display either thepatient name or thepatient identifier onWinView/WebviewerGateway	Yes	Yes, WinView/WebVieweris renamed to PatientWatch	Same.WinView/WebViewer isrenamed to PatientWatch
Network Technology	• TCP/IP• Health Level 7 (HL72.3)• ASTM• HTML, Active X• Windows DynamicLink• Library (DLL)• TAP	• TCP/IP• Health Level 7 (HL7 2.x)• ASTM• HTML, Active X• Windows Dynamic Link• Library (DLL)• TAP	VF9.0 added additionalsupport for protocolinterfaces and supportsdifferent versions of theHL7 2.x protocols forvarious interfaces
Alarm (audible)	Yes	Yes	Audible alarm informationis available only if a pagingservice provides thecapability.No change since VF4, noimpact to the intended use.
Alarm Display String	Advisory (ADV)Serious (SER)Life Threatening (LT)	Advisory (ADV)Serious (SER)Life Threatening (LT)	Available for informationalpurposes only. The primaryalarm notification is at thepatient bedside or theInfinity Central Station.No change since VF4, noimpact to the intended use.
Alarm (Visual)	Yes	Yes	Same
Attribute	Predicate DeviceInfinity Gateway SuiteK043549 - VF4	Subject DeviceInfinity Gateway Suite510(k)#K203579 - VF9.0	Explanation of Similaritiesand Differences
Alarm Grade	Life-ThreateningSeriousAdvisory viaWinView/WebViewer	Yes, WinView/WebVieweris renamed to PatientWatch	PatientWatch alarms areavailable for informationalpurposes and are notavailable for SDCThe alarm grades have notchanged between VF4 andVF9.
Alarm State	ActiveSilencedNone	Yes, via PatientWatch	PatientWatch alarms areavailable for informationalpurposes and are notavailable for SDCThe alarm states have notchanged between VF4 andVF9.

Comparison Table Between the Predicate Device K043549, VF4 and the Subject 510(k) K203579, VF9.0:

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VII. Performance Data

Verification and Validation Testing:

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.

Additionally, all possibly known use related hazards, inclusive those beyond the primary operating functions, that are related to usability have been reviewed. 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 the modified software is substantially equivalent to the predicate device.

Biocompatibility: The proposed enhancement to the Infinity Gateway Suite involves software only. No modifications affecting biocompatibility of the device is being proposed at this time and does not apply.

Sterilization: Sterilization and shelf-life do not apply as the Infinity Gateway Suite is software only.

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Standards/Compliance Testing:

The Infinity Gateway Suite software modifications have been tested and developed in compliance with the following standards:

ANSI AAMI ISO 14971:2019 Medical devices Applications of risk management to ﻬ medical devices
IEEE Std 11073 -10101-2019 Health informatics Point-of-care medical device ﻬ communication. Part 10101: Nomenclature
IEEE Std 11073-10201-2018 Health informatics Point-of-care medical device r communication Part 10201: Domain Information Model
ANSI AAMI IEC 62304:2006/a1:2016 ﮩ
Medical device software Software life cycle processes [Including Amendment 1 r (2016)]
ANSI AAMI IEC 62366-1:2015 Medical devices Part 1: Application of usability ﻬ engineering to medical devices

VIII. Conclusion

The Infinity Gateway Suite significant change modifications are substantially equivalent to the predicate device cleared under K043549 on January 21, 2005. The intended use of the Infinity Gateway Suite as described in the product labeling has not changed as a result of the proposed modifications. Verification and Validation results for the proposed modifications support substantial equivalence to the predicate device.

Regulation Number and Section

§ 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).