(214 days)
No
The description mentions "predictive trend analytics, meaning trending, notification, calculations and clinical advisories including EWS deterioration status," but this is described as standard data processing and calculations, not explicitly AI/ML. There is no mention of AI, DNN, or ML in the text, nor is there any description of training or test sets which are typical for ML-based devices.
No.
The device is a Clinical Information Management System intended for data collection, storage, and management from patient monitors, and provides review, reporting, and analysis, but it does not directly treat or diagnose a disease.
No
The device is described as a "Clinical Information Management System" that collects, stores, and manages data from patient monitors and provides review, reporting, and trend analytics. While it processes clinical data, its stated purpose is not to diagnose conditions but to manage information for healthcare providers.
Yes
The device description explicitly states, "The IntelliVue GuardianSoftware is a software only product." It also mentions it is intended to be installed on customer-supplied off-the-shelf IT equipment, further supporting its software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the software as a Clinical Information Management System for collecting, storing, and managing patient data from monitors and measurements. It focuses on data management, reporting, and clinical documentation.
- Device Description: The description reinforces its role as a data management system, providing features like review, reporting, remote viewing, and predictive trend analytics based on collected vital signs data.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not mention handling or analyzing such specimens. Its input is data from patient monitors and measurements, not biological samples.
Therefore, the IntelliVue GuardianSoftware falls under the category of a clinical information system or patient data management software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IntelliVue GuardianSoftware is indicated for use by healthcare providers whenever there is a need for generation of a patient record.
The IntelliVue GuardianSoftware is intended for use in the collection, storage and management of data from Philips specified measurements and Philips Patient Monitors that are connected through networks.
Product codes
DXJ, NSX, DQK, OUG
Device Description
The IntelliVue GuardianSoftware (866009) is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue Patient Monitors. The IntelliVue GuardianSoftware provides review, reporting, clinical documentation, remote viewing, operating, interfacing, storage, printing and predictive trend analytics, meaning trending, notification, calculations and clinical advisories including EWS deterioration status. The IntelliVue GuardianSoftware is a software only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.
The IntelliVue GuardianSoftware can currently acquire physiological data from the following compatible measuring devices:
- Philips IntelliVue Measurements CL SpO2 Pod, CL NBP Pod, CL Resp Pod, -
- Philips IntelliVue Patient Monitors MX400/XG50, MP5 and MP5SC, and -
- -Philips SureSigns Patient Monitors VS3/VS4
The subject modification adds the Philips Biosensor and the EarlySense InSight Device as additional optional Philips specified measurements to the list of measuring devices compatible with the IntelliVue GuardianSoftware.
To support the before described purposes the IntelliVue GuardianSoftware was modified to maintain a consistent numbering scheme. The modified common software revision is Rev.C.1.
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
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
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject modified devices with respect to the predicate. Testing involved software functional testing and regression testing on an integration and system level as well as testing from the hazard analysis.
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Testing as required by the hazard analysis was conducted and all specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures.
Verification according to the applicable safety and performance standards was conducted as described below:
| Standard | Type |
|---|---|
| IEC 62304:2006 | General Standard: |
| Software life cycle processes |
Pass/Fail criteria were based on the specifications cleared for the predicate device and all test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue GuardianSoftware (SW Rev.C.1) meets all safety and reliability requirements and performance claims.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Philips Medizin Systeme Boeblingen GmbH Michael Asmalsky Senior Regulatory Affairs Engineer Hewlett-Packard-Str. 2 Boeblingen, Baden Wuerttemberg D-71034 GERMANY
September 1, 2023
Re: K161767
Trade/Device Name: Philips IntelliVue Guardian Software Revision C.1 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: Class II Product Code: DXJ, DQK, OUG
Dear Michael Asmalsky:
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 January 27, 2017. Specifically, FDA is updating this SE Letter to remove the secondary product code NSX as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Aneesh Deoras, OHT2: Office of Cardiovascular Devices, 240-402-4363, Aneesh.Deoras@fda.hhs.gov.
Sincerely,
Aneesh S. Deoras -S
for
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
1
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Philips Medizin Systeme Boeblingen GmbH Michael Asmalsky Senior Regulatory Affairs Engineer Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany
Re: K161767
Trade/Device Name: Philips Intellivue Guardian Software Revision C.1 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ, NSX, DQK, OUG Dated: December 20, 2016 Received: December 22, 2016
Dear Michael Asmalsky:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K161767
Device Name
Philips IntelliVue GuardianSoftware, Software Revision C.1
Indications for Use (Describe)
The IntelliVue GuardianSoftware is indicated for use by healthcare providers whenever there is a need for generation of a patient record.
The IntelliVue GuardianSoftware is intended for use in the collection, storage and management of data from Philips specified measurements and Philips Patient Monitors 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
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
1.) The submitter of this premarket notification is:
Michael Asmalsky Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1277 Fax: ++49 7031 463-2442 e-mail: michael.asmalsky@philips.com
This summary was prepared on June 23rd 2016.
2.) The trade names/proprietary names of the device is:
the Philips IntelliVue GuardianSoftware with software Revision C.1.
The common/usual name is:
for the IntelliVue GuardianSoftware: Clinical Information Management System
The Classification names for the IntelliVue GuardianSoftware are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | |||
| Devices | §870.2450, II | DXJ | Display, cathode-ray tube, medical |
| General Hospital | not classified | NSX | Software, transmission and storage, |
| patient data | |||
| Cardiovascular | |||
| Devices | 870.1425, II | DQK | Programmable diagnostic computer |
| General Hospital | §880.6310, I | OUG | Medical Device Data System |
3.) The modified Philips IntelliVue GuardianSoftware (SW Rev. C.1) is substantially equivalent to the previously cleared Philips IntelliVue GuardianSoftware marketed pursuant to K151736.
4.) Description of the Devices:
The IntelliVue GuardianSoftware (866009) is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue Patient Monitors. The IntelliVue GuardianSoftware provides review, reporting, clinical documentation, remote viewing, operating, interfacing, storage, printing and predictive trend analytics, meaning trending, notification, calculations and clinical advisories including EWS deterioration status. The IntelliVue GuardianSoftware is a software only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.
5
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The IntelliVue GuardianSoftware can currently acquire physiological data from the following compatible measuring devices:
- Philips IntelliVue Measurements CL SpO2 Pod, CL NBP Pod, CL Resp Pod, -
- Philips IntelliVue Patient Monitors MX400/XG50, MP5 and MP5SC, and -
- -Philips SureSigns Patient Monitors VS3/VS4
The subject modification adds the Philips Biosensor and the EarlySense InSight Device as additional optional Philips specified measurements to the list of measuring devices compatible with the IntelliVue GuardianSoftware.
To support the before described purposes the IntelliVue GuardianSoftware was modified to maintain a consistent numbering scheme. The modified common software revision is Rev.C.1.
Intended Use:
The Intended Use and Indications for Use of the subject Philips IntelliVue GuardianSoftware (866009) has not changed as a result of the device modifications. The following detailed Indications for Use Statements in its Instructions for Use:
Philips IntelliVue GuardianSoftware:
The IntelliVue GuardianSoftware is indicated for use by healthcare providers whenever there is a need for the generation of a patient record.
The IntelliVue GuardianSoftware is intended for use in the collection, storage and management of data from Philips specified Measurements and Philips Patient Monitors that are connected through networks.
5.) Technological Characteristics:
The modified device has the same technological characteristics as the legally marketed predicate device. It is a software only product intended to be installed on Philips specified standard (of-the-shelf) IT devices. It uses a client server architecture and it is suitable for use with the specified Microsoft® Operating System and Databases.
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6.) Summary of Verification, Validation and Testing Activities and Conclusion:
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject modified devices with respect to the predicate. Testing involved software functional testing and regression testing on an integration and system level as well as testing from the hazard analysis.
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Testing as required by the hazard analysis was conducted and all specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures.
Verification according to the applicable safety and performance standards was conducted as described below:
| Standard | Type |
|---|---|
| IEC 62304:2006 | General Standard: |
| Software life cycle processes |
Pass/Fail criteria were based on the specifications cleared for the predicate device and all test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue GuardianSoftware (SW Rev.C.1) meets all safety and reliability requirements and performance claims.