(138 days)
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 and Philips Patient Monitors that are connected through networks.
The IntelliVue GuardianSoftware (866009) is a Clinical Information Management System. It collects and manages vital signs data acquired from the Philips specified measurements and Philips 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 provided text primarily details an FDA 510(k) submission for the Philips IntelliVue GuardianSoftware and an administrative change letter. It does not contain an elaborative study description with acceptance criteria and its proof for device performance in the requested format.
However, based on the general information provided in the 510(k) summary, I can extract and infer some information, but it will not be a complete answer to all your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. It broadly states:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Performance, functionality, and reliability characteristics met | All test results showed substantial equivalence to the predicate device. |
| Compliance with hazard analysis pass/fail criteria | All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures. |
| Meeting safety and reliability requirements and performance claims | The Philips IntelliVue GuardianSoftware (SW Rev.D.0) meets all safety and reliability requirements and performance claims. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "software testing on integration level (functional testing and regression testing) and software testing on system level (hazard analysis testing and dedicated software performance testing)." It does not indicate the number of patient records or data points used in these tests.
- Data Provenance: Not specified. It does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document does not describe the establishment of a "ground truth" for the test set using human experts. The testing appears to be functional and performance-based against specifications, not clinical outcomes evaluated by experts.
4. Adjudication method for the test set
Not specified. Since no expert ground truth establishment is mentioned, there's no mention of an adjudication method.
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. The document describes the Philips IntelliVue GuardianSoftware as a Clinical Information Management System for collecting, storing, and managing vital signs data, and providing review, reporting, clinical documentation, remote viewing, operating, interfacing, storage, printing, and predictive trend analytics. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device and was not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, implicitly. The testing described is for the software itself, independently verifying its performance, functionality, and reliability according to specifications and safety standards. The device is a "software only product" and its testing would inherently be standalone.
7. The type of ground truth used
For the software verification and validation, the "ground truth" would be the pre-defined specifications, requirements, and safety standards (e.g., ANSI/AAMI/IEC 62304:2006). The software was tested to ensure it met these established criteria. It does not involve medical ground truth like pathology, expert consensus on images, or outcomes data.
8. The sample size for the training set
Not applicable/Not specified. This device is described as a "Clinical Information Management System" that handles data collection, storage, and management, including predictive trend analytics and clinical advisories. While "predictive trend analytics" could potentially involve machine learning, the document does not elaborate on the specific algorithms used or if a training set, characteristic of machine learning models, was employed or is relevant to its substantial equivalence claim. The focus here is on the functionality and safety of the data management software itself.
9. How the ground truth for the training set was established
Not applicable/Not specified, for the same reasons as #8. If predictive trend analytics involve trained models (which is not explicitly stated but hinted at), the method for establishing ground truth for such a training set is not described. The document emphasizes testing against a predicate device's cleared specifications and general software safety 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: K180534
Trade/Device Name: Philips IntelliVue GuardianSoftware with Software Revision D.0 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 July 16, 2018. 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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July 16, 2018
Philips Medizin Systeme Boeblingen GmbH Michael Asmalsky Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 Boeblingen, 71034 DE Baden Wuerttemberg
Re: K180534
Trade/Device Name: Philips IntelliVue GuardianSoftware with software Revision D.0 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ, NSX, DQK, OUG Dated: May 16, 2018 Received: May 21, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/6 description: The image contains the name "Arielle Drummond -S" in a large, bold font. Below the name, the word "For" is written in a smaller font size. The text is centered and appears to be part of a title or heading. The background is plain and does not contain any other elements.
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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Indications for Use
510(k) Number (if known) K180534
Device Name
Philips IntelliVue GuardianSoftware with software Revision D.0
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 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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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, blue, bold letters. Below the word "PHILIPS" is the text "K180534" and "Page 1 of 3". The text is in a smaller font size than the word "PHILIPS".
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 May 15th 2018.
2.) The trade names/proprietary names of the device is:
the Philips IntelliVue GuardianSoftware with software Revision D.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 |
|---|---|---|---|
| CardiovascularDevices | §870.2450, II | DXJ | Display, cathode-ray tube, medical |
| General Hospital | not classified | NSX | Software, transmission and storage,patient data |
| CardiovascularDevices | §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. D.0) is substantially equivalent to the previously cleared Philips IntelliVue GuardianSoftware marketed pursuant to K161767.
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 Philips specified measurements and Philips 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.
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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
- -Philips Wearable Biosensor, and the
- -EarlySense InSight Device.
The subject modification adds the optional support for SW clients for off the shelf, customer provided mobile devices to the currently legally marketed client-server architecture of 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.D.0.
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 device has the following detailed Intended Use and Indications for Use Statements in its Instructions for Use:
Philips IntelliVue GuardianSoftware:
The IntelliVue GuardianSoftware is intended for use by healthcare providers whenever there is a need for the generation of a patient record.
The IntelliVue GuardianSoftware is indicated 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, customer-provided 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. SW clients are optionally suitable for use with customer provided mobile off the shelf devices using Android OS and meeting the specifications.
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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 IntelliVue GuardianSoftware with respect to the predicate. Testing involved software testing on integration level (functional testing and regression testing) and software testing on system level (hazard analysis testing and dedicated software performance testing).
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 |
|---|---|
| ANSI/AAMI/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.D.0) meets all safety and reliability requirements and performance claims.
§ 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).