(199 days)
The intended use of the Philips Patient Information Center iX software application is to:
Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.
Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
- Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2.
Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
Provide review and trend application data, designed to contribute to the screening of patient condition or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to to display medical device data.
The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data. Rx only.
The Philips Patient Information Center uses off-the-shelf Windows PCs and servers, combined with the Patient Information Center iX M3290B software Release C.01 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. Additionally, the M3290B Software provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Compatible Accessories include: Mobile Caregiver – a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate. This is not a new mobile application, and it has no changes that introduce significant risks for the PIC iX C.01 release.
The provided document, a 510(k) premarket notification for the Philips Medical Systems "M3290B Patient Information Center iX Release C.01," primarily focuses on establishing substantial equivalence to a predicate device (M3290B Philips IntelliVue Information Center iX software Revision C.0). The document asserts that the changes in the new device do not introduce significant risks or new clinical applications requiring clinical performance testing. Therefore, it does not describe a clinical study in the traditional sense, particularly one involving an AI algorithm that would have specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or human-AI reader performance.
The device described is a patient information center software, which functions to receive, aggregate, process, distribute, and display physiological data, determine alarm conditions, generate alarm signals, and perform diagnostic 12-Lead analysis and interpretation. The algorithms mentioned (ST/AR ECG for arrhythmia, ST Segment, and QT Segment Monitoring) are present in the software but the performance evaluation described focuses on system-level testing and verification/validation to ensure it functions as intended and is as safe and effective as its predicate.
Based on the provided text, here is an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the form of specific performance metrics (like sensitivity, specificity, accuracy) for a new clinical application or AI algorithm, nor does it present reported device performance against such metrics. Instead, the acceptance criteria are implicitly tied to the system-level functional and safety requirements, and the reported performance is that the device "meets all defined reliability requirements and performance claims" and "test results showed substantial equivalence."
| Acceptance Criteria (Implicit from document) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs functions (receive, aggregate, process, distribute, display data, generate alarms, 12-Lead analysis) as intended and as demonstrated by the predicate device. | "Performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed." |
| Safety: Device operates without introducing new or significant safety risks compared to the predicate. | "Testing involved system level tests, performance tests, and safety testing from hazard analysis." "The M3290B Philips IntelliVue Information Center iX software Release C.01 meets all defined reliability requirements and performance claims." |
| Reliability: Device maintains consistent and dependable operation. | "The M3290B Philips IntelliVue Information Center iX software Release C.01 meets all defined reliability requirements and performance claims." |
| Substantial Equivalence: Device is equivalent to the predicate in design, technology, intended use, safety, and effectiveness. | "M3290B Philips IntelliVue Information Center iX software Release C.01 is substantially equivalent to the predicate device M3290B Philips IntelliVue Information Center iX software Release C.O (K153702)." |
| Adherence to Specifications/Standards: Device complies with Philips' verification and validation processes, and relevant consensus standards. | "Tested in accordance with Philips verification and validation processes." "Complied with the requirements specified in the international and FDA-recognized consensus standards." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "Clinical Performance testing for M3290B Philips IntelliVue Information Center iX software Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."
Therefore, there is no specific test set or clinical data (sample size, provenance) described for evaluating the performance of the integrated algorithms. The testing was non-clinical, focusing on system-level verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no clinical performance study was conducted to evaluate the algorithms' diagnostic performance, there was no ground truth established by experts for a test set. The validation was against the defined specifications and the performance of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
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
Not applicable. The document explicitly states that clinical performance testing was not performed. This device is an information center, not an AI-powered diagnostic tool intended to directly assist human readers in image interpretation or a similar task where MRMC studies are typically conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document alludes to "Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2," and "Perform diagnostic 12-Lead analysis and interpretation". However, it does not describe a standalone performance study for these algorithms. The testing described is system-level verification and validation. The 12-lead analysis is stated to be "based on raw ECG data samples provided from Philips approved medical devices" and the "Result may be displayed, printed and/or distributed". The output data (e.g., from 12-lead analysis) is explicitly stated to "not be the sole source of information for decision making," indicating a human-in-the-loop context, but no study of this combined performance is presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study requiring ground truth was conducted. The assessment relied on verifying that the system's output aligned with predefined functional specifications and matched the performance of the predicate device in a non-clinical testing environment.
8. The sample size for the training set
Not applicable. This document describes a software update for a patient information center, not a machine learning model requiring a training set. The existing algorithms are presumed to be validated from prior predicate device clearances.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is described.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2017
Philips Medical Systems Theresa Poole Regulatory Specialist 3000 Minuteman Road Andover, Massachusetts 01810
Re: K163584
Trade/Device Name: M3290B Patient Information Center iX Release C.01 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DSH, MSX Dated: June 8, 2017 Received: June 9, 2017
Dear Theresa Poole:
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 device
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related 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.
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.
M.A. Hilleman
for.
for 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) K163584
Device Name
M3290B Patient Information Center iX Release C.01
Indications for Use (Describe)
The intended use of the Philips Patient Information Center iX software application is to:
Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.
Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
- Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2.
Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
Provide review and trend application data, designed to contribute to the screening of patient condition or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to to display medical device data.
The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data. Rx only.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
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Image /page/4/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 background is white, which makes the blue letters stand out.
Patient Information Center iX Traditional 510(k)
510(k) Summary Patient Information Center iX Release C.01
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).
Date Prepared: 5 July 2017
l. Submitter's name and address
| Manufacturer: | Philips Medical Systems3000 Minuteman RoadAndover, MA 01810 USA |
|---|---|
| Contact Person: | Theresa PooleRegulatory Affairs SpecialistPhilips Medical Systems3000 Minuteman Road, MS0480Andover, MA 01810-1099 |
| Tel: 978 659 7621Fax: 978 685 5624Email: theresa.poole@philips.com |
II. Device information
Device Name: M3290B Patient Information Center iX software Revision C.01* Common Name: Central Station Classification panel: Cardiovascular
Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| 870.1025, II | MHX | Physiological Monitor, Patient Monitor |
| 870.1025, II | DSI | Arrhythmia Detector and Alarm |
| 870.1025, II | MLD | Monitor, ST Alarm |
| 870.2800, II | DSH | Recorder, Magnetic Tape, Medical |
| 870.2300, II | MSX | System, Network and Communication,Physiological Monitors |
- In Release C.01 the name of the product will be changed from M3290B Philips IntelliVue Information Center iX (PIIC iX) to M3290B Patient Information Center (PIC iX), dropping the Philips and IntelliVue branding in the name. The M3290B model number does not change.
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510(k) Summary
III. Predicate device information
| Trade name: | M3290B Philips IntelliVue Information Center iX software Revision C.0 |
|---|---|
| Manufacturer: | Philips Medical Systems |
| 510(k) clearance: | K153702 |
| Classification name | Central Station |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2300 |
| Classification panel: | Cardiovascular |
| Product code: | MSX |
IV.Device Description
The Philips Patient Information Center uses off-the-shelf Windows PCs and servers, combined with the Patient Information Center iX M3290B software Release C.01 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. Additionally, the M3290B Software provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Compatible Accessories include: Mobile Caregiver – a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate. This is not a new mobile application, and it has no changes that introduce significant risks for the PIC iX C.01 release.
V. Intended use/ Indications for Use
M3290B Intended The intended use of the Philips Patient Information Center iX software Use/Indications for Use application is to:
- Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.
- Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
- . Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2.
- Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
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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 evenly spaced. The background is plain white, which makes the blue letters stand out.
Patient Information Center iX Traditional 510(k)
- Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
- . Provide review and trend application data, designed to contribute to the screening of patient condition All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
- . Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.
The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use.
Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.
Rx only.
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510(k) Summary
VI.Comparison of Technological Characteristics with the Predicate Device
The device has the same technological characteristics as the legally marketed predicate devices. The change summary includes items listed in the table below.
| Key Characteristic | Predicate DevicePIIC iX C.0 (K153702) | Subject DevicePIC iX C.01 |
|---|---|---|
| Applications | Display Setup | The PIC IX release C.01, Changes to support Overviews with Enterprise Link; namely, paradigm shift away from primary and overview monitoring to the concept of principal and ancillary sectors. |
| Manage Patient | The Auto ADT feature can be configured to admit, discharge, and transfer a patient directly from the hospital information system (HIS) to the PIC IX. | |
| Alarm Measurement and Device Control | Release C.01 PIC IX supports IntelliVue X3 Multi-Measurement Modules that are connected to IPM Release M.0 monitors and, Pulse alarm for MX40 B.07 and later. | |
| Domain-Specific Services | Alarm Management | With PIC IX Release C.01, the Alarm Advisor application provides feedback on recurring alarm limit violations for a specific measurement over a period of time, frequent alarm notifications can be configured |
| Patient & Equipment Management | The Patient Management application provides the clinical user with information and controls. | |
| Each patient can be monitored byone or more devices namely IPM,Efficia, PWD, MX40, MRxdefibrillator/monitor, and NIBPand SpO2 sensors. | ||
| Outbound DataServices | Web/Mobility12 LeadData Warehouse | The Web Proxy in PIC iX ReleaseC.01 enables IPM Release M.0monitors to display retrospectivedata as shown with webapplications. For 12-lead ECG Export, the usercan enter the order number, orderreason, requested by, operator,facility, department and comment(1-5) fields. With PIC iX Release C.01, themonitor can resend up to the last10 seconds of wave data. PIC iX Release C.01, allows to sendadditional non-ECG waves andthese are stored in the DataWarehouse. |
| Platform | Windows 8.1 OSWindows Server 2012 R2Hardware Specified in IFU | Windows 10 IoTWindows Server 2012 R2Hardware Specified in IFU |
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Image /page/8/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 background is white, which makes the blue letters stand out.
Patient Information Center iX Rele
Traditional 510(k)
510(k) Summary
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Summary of Non-clinical testing
No performance standards have been issued under the authority of Section 514. The M3290B Philips IntelliVue Information Center iX software Release C.01 was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:
- Risk Analysis
- Product Specifications .
- Design Reviews ●
- . Verification & Validations
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510(k) Summary
Summary of Clinical Testing
Clinical Performance testing for M3290B Philips IntelliVue Information Center iX software Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence.
Conclusions drawn from the Non-clinical and Clinical testing
Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The M3290B Philips IntelliVue Information Center iX software Release C.01 meets all defined reliability requirements and performance claims.
VIII. Conclusion
M3290B Philips IntelliVue Information Center iX software Release C.01 is substantially equivalent to the predicate device M3290B Philips IntelliVue Information Center iX software Release C.O (K153702) in terms of design features, fundamental scientific technology, intended use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance testing, which complied with the requirements specified in the international and FDA-recognized consensus standards. The non-clinical performance tests provided in this 510(k) premarket notification demonstrate that the subject device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.