(117 days)
Not Found
No
The document describes a clinical information management system for collecting and managing vital signs data. It mentions features like trending, reporting, and clinical advisories, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic models. The focus is on data management and standard clinical calculations/advisories (like EWS), not on adaptive or learning algorithms.
No.
The device is a Clinical Information Management System used for collecting, storing, and managing data from patient monitors, not for providing therapy.
Yes
The device, IntelliVue GuardianSoftware, is described as a "Clinical Information Management System" that "collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue Patient Monitors." It provides "trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing." The generation of "clinical advisories including EWS deterioration status" implies it helps healthcare providers make clinical decisions regarding a patient's condition, which aligns with the purpose of a diagnostic device.
Yes
The device description explicitly states "The IntelliVue GuardianSoftware only product." and that it is intended to be installed on customer-supplied off-the-shelf IT equipment. While it interacts with hardware (patient monitors and cableless measurements), the device itself is solely the software component.
Based on the provided text, the IntelliVue GuardianSoftware is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the software as being used by healthcare providers for generating patient records, collecting, storing, and managing data from patient monitors and cableless measurements. This focuses on data management and presentation, not on analyzing samples from the human body to provide diagnostic information.
- Device Description: The description highlights its function as a Clinical Information Management System that collects and manages vital signs data. It provides features like trending, reporting, notification, and remote viewing. These are all related to managing and displaying patient physiological data, not performing in vitro diagnostic tests.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Performing chemical, immunological, or molecular tests
- Providing diagnostic information based on the analysis of samples
The IntelliVue GuardianSoftware is clearly described as a system for managing and displaying physiological data acquired from patient monitoring devices. This falls under the category of patient monitoring and clinical information systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 Cableless Measurements and Philips Patient Monitors that are connected through networks.
Product codes (comma separated list FDA assigned to the subject device)
DXJ, NSX, DQK
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 trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue GuardianSoftware 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 and l
- Philips IntelliVue Patient Monitors MP5 and MP5SC. -
The subject modification adds the Philips IntelliVue MX400/450 patient monitors and the Philips Suresigns VS3/VS4 patient monitors as additional optional Philips patient monitors to the list of measuring devices compatible with the IntelliVue GuardianSoftware and updates the versions of the supported SQL database versions.
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.0
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 devices and all test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue GuardianSoftware (SW Rev. C.0) meets all safety and reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name, "U.S. Food & Drug Administration," written in blue text next to it.
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: K151736
Trade/Device Name: Philips IntelliVue Guardian Software Revision C Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: Class II Product Code: DXJ, DQK
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 October 21, 2015. 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
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2015
Philips Medizin Systeme Boeblingen GmbH Michael Asmalsky Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 Boblingen, 71034 DE
Re: K151736
Trade/Device Name: Philips Intellivue Guardian Software Revision C Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ, NSX, DQK Dated: June 23, 2015 Received: June 26, 2015
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
2
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.
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 yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151736
Device Name
IntelliVue GuardianSoftware, Software Revision C
Indications for Use (Describe)
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 Cableless 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. Above and to the right of the word is the alphanumeric string "K151736". The word "PHILIPS" is the most prominent element in the image.
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 October 15th 2015.
2.) The trade name/proprietary name of the device is:
the Philips IntelliVue GuardianSoftware with software Revision C.0
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 |
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Image /page/5/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is the only element in the image and it is centered.
3.) The modified Philips IntelliVue GuardianSoftware (SW Rev. C.0) is substantially equivalent to the previously cleared Philips IntelliVue GuardianSoftware legally marketed pursuant to K122223.
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 trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue GuardianSoftware 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 and l
- Philips IntelliVue Patient Monitors MP5 and MP5SC. -
The subject modification adds the Philips IntelliVue MX400/450 patient monitors and the Philips Suresigns VS3/VS4 patient monitors as additional optional Philips patient monitors to the list of measuring devices compatible with the IntelliVue GuardianSoftware and updates the versions of the supported SQL database versions.
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.0
Intended Use:
The Intended Use and Indications for Use of the subject Philips IntelliVue GuardianSoftware (866009) and of the subject Philips IntelliVue CL NBP Pod (865216) have not changed as a result of the device modifications. The devices have the following detailed Indications for Use Statements in their 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 Cableless Measurements and Philips Patient Monitors that are connected through networks.
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Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced. The word is the primary focus of the image and is set against a white background.
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 a standard PC or Server. It has client server architecture and it is suitable for use with the specified Microsoft® Operating System and databases.
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 devices and all test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue GuardianSoftware (SW Rev. C.0) meets all safety and reliability requirements and performance claims.