(77 days)
No
The summary describes a clinical information management system with charting, trending, reporting, and a basic early warning score calculation. There is no mention of AI, ML, or any related technologies in the device description or performance studies. The "Guardian Early Warning Score (EWS)" is described as a "basic assessment" and does not imply complex AI/ML algorithms.
No
The device is described as a 'Clinical Information Management System (CIMS)' software application that collects, stores, and manages data from patient monitors and measurements, providing trending, review, reporting, and notification. It is a documentation, charting, and decision-support software. It does not exert any direct therapeutic action on the patient.
No
The device collects, stores, and manages data from patient monitors and provides trending, review, reporting, and notification. While it includes an Early Warning Score application for basic assessment, it explicitly states it is not a diagnostic device ("The IntelliVue GuardianSoftware is not an alarming device and displays alarms from patient monitors as supplemental information only."). Its primary function is clinical information management and decision support, not making a definitive diagnosis.
Yes
The device is described as a "stand-alone 'Clinical Information Management System (CIMS)' software application" intended to be installed on "customer-supplied', compatible off-the-shelf (OTS) information technology (IT) equipment." While it collects data from hardware devices (patient monitors), the device itself is presented as a software application running on existing IT infrastructure, without including or requiring specific proprietary hardware components as part of its medical device definition.
Based on the provided information, the IntelliVue GuardianSoftware is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection, storage, and management of data from patient monitors and measurements, and for generating patient records. It also provides trending, review, reporting, and notification based on this data, including an Early Warning Score. This focuses on managing and interpreting data from the patient, not on analyzing samples from the patient (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The description clearly states it's a "Clinical Information Management System (CIMS)" software application. It collects data from patient monitors and measuring devices. It does not mention any interaction with biological samples or reagents.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, etc.)
- Use of reagents
- Providing diagnostic information based on sample analysis
The IntelliVue GuardianSoftware is a medical device, specifically a clinical information management system, but its function is to manage and interpret data already collected from the patient by other devices, not to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The IntelliVue GuardianSoftware is intended for use by healthcare providers whenever there is a need for generation of a patient record.
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.
Product codes
DXJ, DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare providers / professional healthcare facilities (i.e. hospitals, nursing homes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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).
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.
Key Metrics
Not Found
Predicate Device(s)
Philips IntelliVue Guardian Software, Revision D.0 (K180534)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
2
Indications for Use
Submission Number (if known)
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.
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.
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
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.
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.
4
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.
The basis for submission is modification to the legally marketed device (Software Version D.0). These modifications are as follows:
-
- Addition of HL7 import functionality to include 3td party measurements
-
- 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.
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.
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 Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The IntelliVue GuardianSoftware is
intended for use by healthcare providers
whenever is a need for generation of
patient record. | The IntelliVue GuardianSoftware is
intended for use by healthcare
providers whenever is a need for
generation of patient record. | Substantially Equivalent
IDENTICAL
The IntelliVue GuardianSoftware
(REV. E.0X) and predicate device is
intended for use by healthcare
providers. Both devices generate
patient records. |
| Indications for
Use | 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. | The IntelliVue GuardianSoftware is
indicated for use in the collection,
storage and management of data with
Philips specified measurements and
Philips Patient monitors that are
connected through networks. | Substantially Equivalent
Both devices are indicated for use in
the collection, storage and
management of data.
The IntelliVue GuardianSoftware
(REV. E.0X) includes "qualified 3rd
party measurements" to its
indications for use.
The difference in indications for use
does not affect the substantial
equivalence of the subject device
relative to the predicate.
HL7 testing encompassed the
verification and validation testing of
3rd 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 | |
|---|---|
| Product Features | Subject Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Usability performance demonstrates
the device's safety and performance. |
| | TECHNOLOGY AND SPECIFICATIONS | | |
| System Platform | Client Server Architecture Compliant with Microsoft®
Operating Systems Installable on customer supplied
off the shelf Information
Technology Equipment (physical
or virtual ITE devices) | Client Server Architecture Compliant with Microsoft®
Operating Systems Installable on customer
supplied off the shelf
Information Technology
Equipment (physical or
virtual ITE devices) | Substantially Equivalent
IDENTICAL
Both devices utilize identical system
platforms. |
| Operating
System(s) and
Database | 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 for
mobile 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 (only
for mobile client) | Substantially Equivalent
Both devices utilize Windows, Win
Servers, Microsoft SQL Server and
Android.
Differences in the operating systems
(OS) are as follows:
Windows
As of January 2020,
Windows 7 is no longer
supported by Microsoft.
Therefore, this has been
removed as a compatible
operating system for the |
| Product Features | Subject Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
| | | | subject device.
Win Server
As of January 2020, Win
Server 2008R2 is no longer
supported by Microsoft.
Win Server 2019 is the
newest operating system
supported by Microsoft and
replaces Win Server
2008R2. To ensure
adequate updates, the
predicate device's
compatible operating system
includes Win Server 2019
and the obsoleted Win
Server 2008R2 has been
removed. Android
As of March 2020, Android
4.4 is no longer supported by
Google. Android 5.0 is the
newest operating system
supported by Google and
replacing Android 4.4. The
predicate device includes the
Android 5.0 and the
obsoleted Android 4.4 has
been removed. |
| Product Features | Subject Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
| | | | The addition and removal of
operating systems ensures continued
support by the operating system
(OS) developer.
The difference in operating systems
(OS) do not affect the substantial
equivalence of the subject device
relative to the predicate. |
| Programming
Language | Microsoft® .NET C# Microsoft® .NET C++ Java (only for mobile client) | Microsoft® .NET C# Microsoft® .NET C++ Java (only for mobile client) | Substantially Equivalent
IDENTICAL |
| Maximum # of
Supported | Patients: 1200 Servers: 120 Clients: 240 SW Clients: 40 | Patients: 1200 Servers: 120 Clients: 240 SW Clients: 40 | Substantially Equivalent
IDENTICAL
The maximum number of supported
patients, servers, clients and SW
clients are identical. |
| Compatible
Devices | Philips IntelliVue Cableless
Measurements CL SpO2 Pod, CL NBP Pod, Cl Respiration Pod Philips IntelliVue patient monitors
MP5 and MP5SC Philips IntelliVue MX400/XG50
patient monitors Philips SureSigns VS3/VS4 patient | Philips IntelliVue Cableless
Measurements CL SpO2
Pod, CL NBP Pod, Cl Respiration
Pod Philips IntelliVue patient
monitors MP5 and MP5SC Philips IntelliVue | Substantially Equivalent
Both subject and predicate device
are compatible with the following
devices:
Philips IntelliVue Cableless
Measurements CL SpO2
Pod, CL |
| Product Features | Subject Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
| | monitors
Philips EarlyVue VS30 patient monitor Philips Wearable Biosensor EarlySense Insight Device Philips Biosensor BX100 | MX400/XG50 patient
monitors 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 as
compatible devices for the subject
device: Philips EarlyVue VS30 patient monitor (K190624) Philips Biosensor BX100 (K192875) These compatible devices are new
devices released to market.
The addition of patient monitoring
devices do not affect the substantial
equivalence of the subject device
relative to the predicate. |
| SOFTWARE FUNCTIONALITY | | | |
| General
Overview | Clinical Documentation Patient Data Management | Clinical Documentation Patient Data Management | Substantially Equivalent
IDENTICAL |
| Product Features | Subject Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
| | 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 Network
Requirements) | 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 Equivalent
The 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 Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
| | | | does not affect the substantial
equivalence of the subject device
relative to the predicate. |
| Device Interfaces | Internal (part of IntelliVue Guardian
Software) interface for connection to
measuring devices through hospital LAN | Internal (part of IntelliVue Guardian
Software) interface for connection to
measuring devices through hospital
LAN | Substantially Equivalent
IDENTICAL |
| REMOTE CHARACTERISTICS | | | |
| Remote Viewing | Remote viewing of compatible
measuring devices by providing an
independent display interface Real-time display of the measuring
devices (waves, numerics, alarms,
operating functions) One monitor/patient at a time per
client Connection through networks, by
using Infrastructure Service | Remote viewing of
compatible measuring
devices by providing an
independent display interface Real-time display of the
measuring devices (waves,
numerics, alarms, operating
functions) One monitor/patient at a time
per client Connection through
networks, by using
Infrastructure Service | Substantially Equivalent
IDENTICAL |
Image /page/6/Picture/5 description: The image contains the Philips logo. The logo is a blue shield shape with the word "PHILIPS" in white letters at the top. Inside the shield are two wavy lines and two stars. The background of the shield is white.
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Philips IntelliVue GuardianSoftware (Rev. 0X)
Image /page/7/Picture/4 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two stars, one at the top and one at the bottom. In the middle, there are two wavy lines that resemble water or sound waves. The word "PHILIPS" is written in white at the top of the shield.
8
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.
9
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.
10
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.
11
Image /page/11/Picture/3 description: The image shows the Philips logo. The logo is blue and white. The word "PHILIPS" is in white text at the top of the logo. Below the text is a symbol with two wavy lines and two stars.
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| Product Features | Subject Device
IntelliVue GuardianSoftware
(Model: REV. E.0X) | Predicate Device
IntelliVue GuardianSoftware
(Model: REV. D.0)
510(k) K180534 | Substantial Equivalence
Determination |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Remote
Operation | Remote operation of compatible
measuring devices by providing an
independent operating user
interface All operations are provided by the
host measuring device Using the end-user supplied PC
user interface (i.e. mouse,
touchscreen) Connection through networks, by
using XDS Infrastructure Service | Remote operation of
compatible measuring
devices by providing an
independent operating user
interface All operations are provided
by the host measuring device Using the end-user supplied
PC user interface (i.e. mouse,
touchscreen) Connection through
networks, by using XDS
Infrastructure Service | Substantially Equivalent
IDENTICAL |
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.
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