The IntelliVue GuardianSoftware is indicated for use in the collection, storage and management of data from Philips specified measurements, Philips Patient Monitors and qualified 3rd party measurements that are connected through networks.

Device Description

The IntelliVue GuardianSoftware is a stand-alone 'Clinical Information Management System (CIMS)' software application with client-server architecture and designed to be used in professional healthcare facilities (i.e. hospitals, nursing homes) and is intended to be installed on a 'customer-supplied', compatible off-the-shelf (OTS) information technology (IT) equipment.

The IntelliVue GuardianSoftware is a documentation, charting, and decision-support software that is configurable by the hospital to suit the needs of individual clinical units. The device collects data/vital signs from the following Philips compatible patient monitor/measuring devices.

Using the collected data, the device provides trending, review, reporting and notification. The 'Guardian Early Warning Score (EWS)' application is integrated into the IntelliVue GuardianSoftware to provide the healthcare professional/provider basic assessment and the ability to recognize early signs of deterioration in patients.

The IntelliVue GuardianSoftware is not an alarming device and displays alarms from patient monitors as supplemental information only.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain specific quantitative acceptance criteria or a side-by-side performance comparison of the new device versus these criteria. Instead, the document focuses on demonstrating substantial equivalence to a predicate device. The acceptance is implied by the successful software verification and validation, as well as human factors testing, which collectively show the device "met all safety and reliability requirements and performance claims."

The closest we get to "performance" in the context of the comparison is in the "Substantial Equivalence Determination" column, which consistently states "IDENTICAL" or provides explanations for differences that do not affect substantial equivalence.

Key areas assessed for equivalence (and thus, implicit "performance" against the predicate):

Feature	Predicate Device (Rev. D.0)	Subject Device (Rev. E.0X)	Acceptance/Equivalence Determination
Intended Use	Identical	Identical	Substantially Equivalent (IDENTICAL)
Indications for Use	Collection, storage, management of data from Philips specified measurements & Patient monitors.	Collection, storage, management of data from Philips specified measurements, Patient Monitors, and qualified 3rd party measurements.	Substantially Equivalent (Difference in indications for use does not affect substantial equivalence, HL7 testing verified 3rd party measurements.)
System Platform	Client Server Architecture, Microsoft OS, OTS IT equipment	Identical	Substantially Equivalent (IDENTICAL)
Operating System(s) & Database	Windows 7/8.1/10, Win Server 2008R2/2012R2/2016, SQL 2014/2016/2017, Android 4.4+	Windows 8.1/10, Win Server 2012R2/2016/2019, SQL 2014/2016/2017, Android 5.0+	Substantially Equivalent (Updates to OS versions (removal of unsupported, addition of newer) ensure continued support and do not affect substantial equivalence.)
Programming Language	Microsoft® .NET C#, Microsoft® .NET C++, Java (mobile client)	Identical	Substantially Equivalent (IDENTICAL)
Maximum # of Supported Patients/Servers/Clients	Patients: 1200, Servers: 120, Clients: 240, SW Clients: 40	Identical	Substantially Equivalent (IDENTICAL)
Compatible Devices	Philips IntelliVue Cableless Measurements, MP5/MP5SC, MX400/XG50, SureSigns VS3/VS4, Biosensor EarlySense Insight Device	Adds Philips EarlyVue VS30 (K190624) and Philips Biosensor BX100 (K192875)	Substantially Equivalent (Addition of new patient monitoring devices does not affect substantial equivalence.)
Software Functionality (General Overview)	Clinical Documentation, Patient Data Management, Reporting (SBAR), Calculations (Protocol Watch, EWS Scoring), Clinical decision support, Storage	Identical	Substantially Equivalent (IDENTICAL)
System Interfaces (IT Network Requirements)	Hospital IT (W)LAN infra, HL7, ADT, Labs, Paging	Adds HL7 data import extension	Substantially Equivalent (Addition of HL7 data import expands compatibility to 3rd party systems and does not affect substantial equivalence.)
Device Interfaces	Internal interface for connection to measuring devices via hospital LAN	Identical	Substantially Equivalent (IDENTICAL)
Remote Viewing/Operation	Independent display/operating interface, operations from host measuring device, PC UI (mouse/touchscreen), XDS Infrastructure Service	Identical	Substantially Equivalent (IDENTICAL)

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" in terms of patient data. The evaluation relies on:

Software Verification and Validation Testing: This is typically performed on software builds and simulated environments, not directly on patient data.
Human Factors and Usability Testing: This involves human users interacting with the device. The sample size for this specific testing is not mentioned.
Data Provenance: Not applicable in the context of patient data testing, as no patient data was used for performance evaluation of the software itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Since the evaluation focused on software verification/validation and human factors/usability, and not on clinical performance with patient data requiring expert ground truth, this type of detail is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No adjudication method is mentioned, as there was no test set requiring expert adjudication for clinical ground truth.

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:

No MRMC comparative effectiveness study was conducted or mentioned. The device is a "Clinical Information Management System" and not an AI-assisted diagnostic tool for human readers. It collects, stores, and manages data, and provides decision support (e.g., Early Warning Score), but it doesn't appear to directly assist human readers in interpreting medical images or other complex data where "improvement" with AI would be measured.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is inherently a "Clinical Information Management System (CIMS) software application" that operates in a standalone manner as software. However, its function as data collection, storage, management, and providing decision support (like EWS) means it is intended for use by healthcare providers and is integrated into clinical workflows. The performance testing focuses on its software functionality, reliability, and human factors, rather than a diagnostic algorithm's standalone performance. The "Guardian Early Warning Score (EWS)" is an algorithm, and its performance would be assessed for accuracy in calculating scores, but the document doesn't provide details on its standalone performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the software verification and validation, the "ground truth" would be the expected functional behavior and output of the software as defined by its requirements and specifications. For human factors testing, the ground truth would be the expected safe and effective interaction of users with the device. There isn't an external clinical ground truth (like pathology or outcomes) applied to the software's performance itself in this submission.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning model where a specific training set (of patient data) would be used. The software is developed based on engineering principles and regulatory requirements.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI/machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

September 30, 2021

Philips Medizin Systeme Boeblingen GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K212208

Trade/Device Name: Philips IntelliVue GuardianSoftware (Rev. E.0X) Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ, DQK Dated: September 15, 2021 Received: September 16, 2021

Dear Prithul Bom:

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.

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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 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 (QS) 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 Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K212208

Device Name

Philips IntelliVue GuardianSoftware (Rev. E.0X) (866009)

Indications for Use (Describe)

The IntelliVue GuardianSoftware is intended for use by healthcare providers whenever there is a need for generation of a patient record.

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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510(K) SUMMARY

The 510(k) summary was prepared in accordance with the requirements with CFR 807.92.

SUBMITTER L

DATE PREPARED: 03 May 2021

APPLICANT: Philips Medizin Systeme Boeblingen Monitoring & Analytics and Therapeutic Care Hewlett-Packard-Strasse 2, 71034 Böblingen, Germany Tel .: 0049- (7031)-463-0 Fax: 0049- (7031)-463-2442

OFFICIAL Johannes Schmid CORRESPONDENT: Senior Regulatory Affairs Engineer Hewlett-Packard-Strasse 2, 71034 Böblingen, Germany Tel.: 0049- (7031)-463-1315 Fax: 0049- (7031)-463-2442 johannes.schmid(@philips.com

II. DEVICE INFORMATION

TRADE NAME: Philips IntelliVue GuardianSoftware (Rev. E.0X)

COMMON NAME: Clinical Information Management System

CLASSIFICATION: Class II, 21 CFR 870.2450

PRODUCT CODE: DXJ: Display, cathode-ray tube, medical

SUB PRODUCT CODE: DQK: Programmable diagnostic computer

III. PREDICATE INFORMATION

PREDICATE DEVICES: Philips IntelliVue Guardian Software, Revision D.0 (K180534) The predicate device has not been subject to a design related recall.

IV. DEVICE DESCRIPTION

Image /page/3/Picture/18 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and three stars, also in white. The logo is simple and recognizable, representing the brand's identity.

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The IntelliVue GuardianSoftware is not an alarming device and displays alarms from patient monitors as supplemental information only.

The basis for submission is modification to the legally marketed device (Software Version D.0). These modifications are as follows:

1. Addition of the Philips Patient Monitors, Biosensor BX100 (K192875) and Early Vue VS30 (K190624), as compatible patient monitor/measuring devices
1. Addition of HL7 import functionality to include 3td party measurements
1. To maintain consistent numbering scheme. The modified internal software revision is Rev. E.0X, where 'X' denotes sequential revision numbering.

V. INTENDED/INDICATIONS FOR USE

The IntelliVue GuardianSoftware is intended for use by healthcare providers whenever there is a need for generation of a patient record.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE PERFORMANCE DATA

The modified device has the same intended use, operating principle and technological characteristics as the legally marketed predicate device.

Table 1, below, provides a high-level comparison of the technological characteristics between the Philips IntelliVue GuardianSoftware (Rev. E.0X) and the Philips IntelliVue GuardianSoftware Revision D.0 (K180534).

Image /page/4/Picture/15 description: The image features the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are stylized white waves and stars, creating a distinctive and recognizable brand symbol.

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Table 1: Comparison Table

Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
Intended Use	The IntelliVue GuardianSoftware isintended for use by healthcare providerswhenever is a need for generation ofpatient record.	The IntelliVue GuardianSoftware isintended for use by healthcareproviders whenever is a need forgeneration of patient record.	Substantially EquivalentIDENTICALThe IntelliVue GuardianSoftware(REV. E.0X) and predicate device isintended for use by healthcareproviders. Both devices generatepatient records.
Indications forUse	The IntelliVue GuardianSoftware isindicated for use in the collection, storageand management of data from Philipsspecified measurements. Philips PatientMonitors and qualified 3rd partymeasurements that are connected throughnetworks.	The IntelliVue GuardianSoftware isindicated for use in the collection,storage and management of data withPhilips specified measurements andPhilips Patient monitors that areconnected through networks.	Substantially EquivalentBoth devices are indicated for use inthe collection, storage andmanagement of data.The IntelliVue GuardianSoftware(REV. E.0X) includes "qualified 3rdparty measurements" to itsindications for use.The difference in indications for usedoes not affect the substantialequivalence of the subject devicerelative to the predicate.HL7 testing encompassed theverification and validation testing of3rd party measurements.

Image /page/5/Picture/5 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" at the top. Inside the shield are two stars and three wavy lines. The stars are four-pointed and are located on either side of the wavy lines.

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Traditional 510(k)

510(k) Summary K212208

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Philips IntelliVue GuardianSoftware (Rev. 0X)

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Image /page/8/Picture/4 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" at the top. Inside the shield are two stars and three wavy lines.

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Image /page/9/Picture/4 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" at the top. Inside the shield is a white emblem with two stars and two wavy lines. The logo is simple and recognizable.

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Image /page/10/Picture/4 description: The image shows the Philips logo, which is a blue shield with the word "PHILIPS" in white at the top. Below the word, there are two wavy lines with a four-pointed star above and below them. The logo is simple and recognizable, representing the brand's identity.

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Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
RemoteOperation	Remote operation of compatiblemeasuring devices by providing anindependent operating userinterface All operations are provided by thehost measuring device Using the end-user supplied PCuser interface (i.e. mouse,touchscreen) Connection through networks, byusing XDS Infrastructure Service	Remote operation ofcompatible measuringdevices by providing anindependent operating userinterface All operations are providedby the host measuring device Using the end-user suppliedPC user interface (i.e. mouse,touchscreen) Connection throughnetworks, by using XDSInfrastructure Service	Substantially EquivalentIDENTICAL

Image /page/12/Picture/6 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" at the top. Inside the shield, there are two wavy lines and two four-pointed stars.

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VII. PERFORMANCE DATA

The following were not applicable in the determination of substantial equivalence with regards to performance:

. Biocompatibility
Electrical Safety and Electromagnetic Compatibility (EMC)
Animal Study
Clinical Studies ●

The following performance testing was conducted in the determination of substantial equivalence:

Performance Testing Bench ●
Software Verification and Validation Testing ●

Performance Testing - Bench (Human Factors and Usability)

This section is only applicable to the Philips IntelliVue GuardianSoftware (E.0X) to:

. Demonstrate human factors (HF)/usability engineering (UE) has been considered and to ensure use-related hazards, and
Risks have been reduced/removed relevant to HF/Usability.

No mechanical testing was conducted, as this is a software-only device. No bench testing was conducted using ex vivo, in vitro, or in situ animal or human tissue, or animal carcass or human cadavers.

Testing demonstrated that the Philips IntelliVue GuardianSoftware as safe and effective for the intended use, intended users, and use environment, as the predicate device.

Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided per FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The Philips IntelliVue GuardianSoftware (Rev. E.0X) Level of Concern (LoC) was determined to be Major because the software provides diagnostic information that directly influences the clinician's treatment/therapy decision and could potentially result in serious injury or death to a patient.

Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the subject device with respect to the predicate device. Tests included software testing on an integration level (software functional testing and regression testing) and software testing on a system level (hazard analysis testing and dedicated software performance testing and functional software security testing in system connectivity).

Image /page/13/Picture/20 description: The image features the Philips logo, which is a shield-shaped emblem in a vibrant blue color. The word "PHILIPS" is prominently displayed at the top of the shield in bold, white letters. Inside the shield, there are two wavy lines and four stars, all in white, creating a visually appealing and recognizable brand symbol.

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Tests confirmed and support the effectiveness of the implemented design risk mitigation measures; as well as demonstrated that the Philips IntelliVue GuardianSoftware (Rev.E.0X) met all safety and reliability requirements and performance claims.

The following performance testing are not applicable to the subject device as it is a standalone software device:

. Biocompatibility
Electrical Safety and Electromagnetic Compatibility (EMC)
Animal Study ●
Clinical Studies

VII. CONCLUSION

The results of the substantial equivalence assessment, taken together with non-clinical bench (human factors and usability) testing, software verification testing demonstrate that the Philips IntelliVue GuardianSoftware (Rev. E.0X) does not raise different questions of safety and effectiveness when compared to the predicate, performs as intended, and has performance characteristics that are substantially equivalent to the Philips IntelliVue GuardianSoftware Rev. D.0 predicate device.

Image /page/14/Picture/10 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two horizontal wavy lines and two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield.

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).

Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
			Usability performance demonstratesthe device's safety and performance.
	TECHNOLOGY AND SPECIFICATIONS
System Platform	Client Server Architecture Compliant with Microsoft®Operating Systems Installable on customer suppliedoff the shelf InformationTechnology Equipment (physicalor virtual ITE devices)	Client Server Architecture Compliant with Microsoft®Operating Systems Installable on customersupplied off the shelfInformation TechnologyEquipment (physical orvirtual ITE devices)	Substantially EquivalentIDENTICALBoth devices utilize identical systemplatforms.
OperatingSystem(s) andDatabase	Windows 8.1 Windows 10 Win Server 2012 R2 Win Server 2016 Win Server 2019 Microsoft SQL Server 2014 Microsoft SQL Server 2016 Microsoft SQL Server 2017 Android 5.0 or higher (only formobile client)	Windows 7 Windows 8.1 Windows 10 Win Server 2008R2 Win Server 2012 R2 Win Server 2016 Microsoft SQL Server 2014 Microsoft SQL Server 2016 Microsoft SQL Server 2017 Android 4.4 or higher (onlyfor mobile client)	Substantially EquivalentBoth devices utilize Windows, WinServers, Microsoft SQL Server andAndroid.Differences in the operating systems(OS) are as follows:WindowsAs of January 2020,Windows 7 is no longersupported by Microsoft.Therefore, this has beenremoved as a compatibleoperating system for the
Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
			subject device.Win ServerAs of January 2020, WinServer 2008R2 is no longersupported by Microsoft.Win Server 2019 is thenewest operating systemsupported by Microsoft andreplaces Win Server2008R2. To ensureadequate updates, thepredicate device'scompatible operating systemincludes Win Server 2019and the obsoleted WinServer 2008R2 has beenremoved. AndroidAs of March 2020, Android4.4 is no longer supported byGoogle. Android 5.0 is thenewest operating systemsupported by Google andreplacing Android 4.4. Thepredicate device includes theAndroid 5.0 and theobsoleted Android 4.4 hasbeen removed.
Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
			The addition and removal ofoperating systems ensures continuedsupport by the operating system(OS) developer.The difference in operating systems(OS) do not affect the substantialequivalence of the subject devicerelative to the predicate.
ProgrammingLanguage	Microsoft® .NET C# Microsoft® .NET C++ Java (only for mobile client)	Microsoft® .NET C# Microsoft® .NET C++ Java (only for mobile client)	Substantially EquivalentIDENTICAL
Maximum # ofSupported	Patients: 1200 Servers: 120 Clients: 240 SW Clients: 40	Patients: 1200 Servers: 120 Clients: 240 SW Clients: 40	Substantially EquivalentIDENTICALThe maximum number of supportedpatients, servers, clients and SWclients are identical.
CompatibleDevices	Philips IntelliVue CablelessMeasurements CL SpO2 Pod, CL NBP Pod, Cl Respiration Pod Philips IntelliVue patient monitorsMP5 and MP5SC Philips IntelliVue MX400/XG50patient monitors Philips SureSigns VS3/VS4 patient	Philips IntelliVue CablelessMeasurements CL SpO2Pod, CL NBP Pod, Cl RespirationPod Philips IntelliVue patientmonitors MP5 and MP5SC Philips IntelliVue	Substantially EquivalentBoth subject and predicate deviceare compatible with the followingdevices:Philips IntelliVue CablelessMeasurements CL SpO2Pod, CL
Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
	monitorsPhilips EarlyVue VS30 patient monitor Philips Wearable Biosensor EarlySense Insight Device Philips Biosensor BX100	MX400/XG50 patientmonitors Philips SureSigns VS3/VS4 patient monitors Philips Wearable Biosensor EarlySense Insight Device	NBP Pod, Cl Respiration Pod Philips IntelliVue patient monitors MP5 and MP5SC Philips IntelliVue MX400/XG50 patient monitors Philips SureSigns VS3/VS4 patient monitors Philips Wearable Biosensor EarlySense Insight Device The following have been added ascompatible devices for the subjectdevice: Philips EarlyVue VS30 patient monitor (K190624) Philips Biosensor BX100 (K192875) These compatible devices are newdevices released to market.The addition of patient monitoringdevices do not affect the substantialequivalence of the subject devicerelative to the predicate.
SOFTWARE FUNCTIONALITY
GeneralOverview	Clinical Documentation Patient Data Management	Clinical Documentation Patient Data Management	Substantially EquivalentIDENTICAL
Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
	Reporting (SBAR Reports) and Printing Calculations (Protocol Watch, EWS Scoring) Clinical decision support / clinical advisories Storage	Reporting (SBAR Reports) and Printing Calculations (Protocol Watch, EWS Scoring) Clinical decision support / clinical advisories Storage
INTERFACES
System Interfaces(IT NetworkRequirements)	Hospital IT (W)LAN infrastructure (customer responsibility) HL7, ADT, Labs, Paging HL7 system interface has been extended to provide HL7 data import	Hospital IT (W)LAN infrastructure (customer responsibility) HL7, ADT, Labs, Paging	Substantially EquivalentThe subject and predicate device interface with: Hospital IT (W)LAN infrastructure (customer responsibility) HL7, ADT, Labs, Paging The difference is that the HL7 system interface (K151736) has been extended to provide HL7 data import. The HL7 data import provides additional interfacing capabilities from third party systems. This change allows for the subject device to expand its compatibility to include third party connection.The addition of HL7 data import
Product Features	Subject DeviceIntelliVue GuardianSoftware(Model: REV. E.0X)	Predicate DeviceIntelliVue GuardianSoftware(Model: REV. D.0)510(k) K180534	Substantial EquivalenceDetermination
			does not affect the substantialequivalence of the subject devicerelative to the predicate.
Device Interfaces	Internal (part of IntelliVue GuardianSoftware) interface for connection tomeasuring devices through hospital LAN	Internal (part of IntelliVue GuardianSoftware) interface for connection tomeasuring devices through hospitalLAN	Substantially EquivalentIDENTICAL
REMOTE CHARACTERISTICS
Remote Viewing	Remote viewing of compatiblemeasuring devices by providing anindependent display interface Real-time display of the measuringdevices (waves, numerics, alarms,operating functions) One monitor/patient at a time perclient Connection through networks, byusing Infrastructure Service	Remote viewing ofcompatible measuringdevices by providing anindependent display interface Real-time display of themeasuring devices (waves,numerics, alarms, operatingfunctions) One monitor/patient at a timeper client Connection throughnetworks, by usingInfrastructure Service	Substantially EquivalentIDENTICAL