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 arthythmia, 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. 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 professionals. The Information Center Software is not intended for home use.

Indicated for use when monitoring adult and/or specified pediatic subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.

Rx only.

Device Description

The Philips Information Center uses off-the-shelf Windows PCs and servers, combined with the M3290B Patient Information Center iX software Release C.03 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 Patient Information Center iX software Release C.03 provides for the retrospective review of alarms, physiologic waves and parameters from its database.

Additionally, the M3290B Patient Information Center iX software Release C.03 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 device.

AI/ML Overview

The provided text describes the Philips M3290B Patient Information Center iX Release C.03 and its substantial equivalence to a predicate device. However, it explicitly states that no clinical performance testing was performed for the new device. Therefore, the specific information requested regarding acceptance criteria, reported device performance metrics, sample sizes, expert qualifications, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document.

The document primarily focuses on non-clinical performance and a comparison of technical characteristics with the predicate device to argue for substantial equivalence.

Here's the breakdown based on the information provided and not provided in the document:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated with quantifiable metrics for clinical performance. The document mentions "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." This suggests internal performance and functionality goals were met, but specific clinical acceptance criteria are not detailed.
Reported Device Performance: Not reported as no clinical performance testing was done.

2. Sample sized used for the test set and the data provenance:

Not provided. No clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. No clinical test set requiring expert ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not provided. No clinical test set requiring 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:

No, an MRMC study was NOT done. The document states: "Clinical Performance testing for M3290B Philips Patient Information Center iX software Release C.03 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."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

While the device includes algorithms (ST/AR ECG for arrhythmia, ST Segment and QT Segment Monitoring, and SpO2), the document does not detail any standalone performance studies for these algorithms. Its focus is on the overall "Patient Information Center iX software application" and its substantial equivalence to the predicate. The changes primarily relate to a user-adjustable QRS detection threshold, which was a feature already cleared on another Philips product (K014261).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not provided for clinical performance. For internal verification and validation, the ground truth would typically be based on product specifications and risk analysis, but this is not clinical ground truth.

8. The sample size for the training set:

Not applicable/Not provided. As no new clinical performance testing was performed, details about training sets for algorithms are not discussed in this document.

9. How the ground truth for the training set was established:

Not applicable/Not provided.

Summary of Device Changes and Justification for No Clinical Study:

The primary change in the M3290B Patient Information Center iX Release C.03 compared to its predicate (Release C.01) is the addition of a user-adjustable minimum QRS detection threshold. This feature was previously cleared on Philips ST/AR, ST and Arrhythmia Algorithm Software (K014261). The manufacturer argues that this, along with other non-significant changes (such as system scalability increases, cybersecurity improvements, and OS updates), does not introduce new clinical features or risks that would necessitate new clinical performance testing. Therefore, "Clinical Performance testing... 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."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Philips Medical Systems Peng Cui, Regulatory Specialist 3000 Minuteman Road Andover, Massachusetts 01810

Re: K183387

Trade/Device Name: M3290B Patient Information Center iX 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, MSX, OUG Dated: April 26, 2019 Received: April 29, 2019

Dear Peng Cui:

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/cfpmp/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.

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

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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 medical devices and radiation-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,

Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K183387

Device Name

M3290B Patient Information Center iX Release C.03

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 arthythmia, 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. 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 professionals. The Information Center Software is not intended for home use.

Indicated for use when monitoring adult and/or specified pediatic 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)

X 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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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."

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M3290B Patient Information Center iX Release C.03

This summary of safety and effectiveness information is submitted in accordance with 21CFR 8807.92

1. Submitter's name, address, telephone number, contact person.

Manufacturer: Philips Medical Systems 3000 Minuteman Road Andover, MA 01810, USA
Peng Cui, Contact person: Sr. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810, USA Email: peng.cui(@philips.com Tel: (978) 659-7966

Date prepared: July 10, 2019

1. Name of the device, including the trade or proprietarv name if applicable, the common or usual name, and the classification name, if known:
  Common/usual name: Central Station M3290B Patient Information Center iX Proprietary name: Classification panel: Cardiovascular

This device is classified as follows:

Classification	Classification Name	Product Code
870.1025, II	Physiological Monitor, Patient Monitor	MHX
870.1025, II	Arrhythmia Detector and Alarm	DSI
870.1025, II	Monitor, ST Alarm	MLD
870.2800, II	Recorder, Magnetic Tape, Medical	DSH
870.2300, II	System, Network and Communication,Physiological Monitors	MSX
880.6310 I	Medical Device Data System	OUG

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3. Predicate device information

Philips Medical Device believes the M3290B Patient Information Center iX (PIC iX) Release C.03 is substantially equivalent to the following legally marketed device:

Predicate device	Manufacturer	510(k)
M3290B Patient InformationCenter iX Release C.01	Philips Medical Systems	K163584

4. Device description

Additionally, the M3290B Patient Information Center iX software Release C.03 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 device.

5. Intended use/Indications for use

The intended use of the M3290B 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 o devices, that send physiological data and do not have the ability to determine the alarm condition.
- 트 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.

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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.

The intended use/indications for use of M3290B Patient Information Center iX Release C.03, provided above, are same as that of the legally marketed and predicate device, Philips M3290B Patient Information Center iX Release C.01 (K163584).

6. Comparison of technical Characteristics with the predicate device

The M3290B Patient Information Center iX Release C.03 and the legally marketed and predicate device, Philips M3290B Patient Information Center iX Release C.01(K163584), employ the same fundamental scientific technology. The primary difference is the change in the QRS detection threshold. In M3290B Patient Information Center iX Release C.01(K163584), the minimum QRS detection threshold is fixed at 150uV and is not user adjustable. In M3290B Patient Information Center iX Release C.03, a manual mode of QRS detection has been added so that the minimum QRS detection threshold can be user adjustable. Note that the user adjustable minimum QRS detective threshold feature was cleared on Philips ST/AR, ST and Arrhythmia Algorithm Software (K014261).

A comparison of the proposed M3290B Patient Information Center iX Release C.03 to the legally marketed and predicate device, Philips M3290B Patient Information Center iX Release C.01(K163584), is provided in Table 1 below:

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Keycharacteristic	M3290B PIC iX C.01K163584	M3290B PIC iX C.03	Comment
	(Predicate Device)	(Subject Device)
Intended Use/Indications foruse	The intended use of the M3290BPatient Information Center iXsoftware application is to:Receive, aggregate, process,distribute and displayphysiologic waves,parameters, alarms andevents at locations otherthan at the patient, formultiple patients. Determine alarm conditionsand generate alarm signalsfor Philips approvedmedical devices, that sendphysiological data and donot have the ability todetermine the alarmcondition. Algorithms presentin the software arelimited to theST/AR ECG (forarrhythmia, STSegment and QTSegmentMonitoring) andSpO2. Generate alarm signals foruser notification, based onthe alarm signal determinedand sent by Philipsapproved medical devices. Perform diagnostic 12-Leadanalysis and interpretationbased on raw ECG datasamples provided fromPhilips approved medicaldevices. Result may bedisplayed, printed and/ordistributed to Philipsapproved medical devices. Provide review and trendapplication data, designed to	Same	No change
	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.
Minimum QRS detection threshold	fixed at 150 $\mu$ V	User adjustable with the following choices: 150 $\mu$ V 200 $\mu$ V 250 $\mu$ V	User adjustable Minimum QRS detection threshold feature was cleared on
		300 μV 350 μV	Philips ST/AR,ST andArrhythmiaAlgorithmSoftware(K014261)
Applications	Retrospective ReviewCaregiver AssignmentSurveillance Display Management Patient Alarm measurement anddevice control	Same	No Change
Domain-SpecificService	Physiological Data SourceControls Wave Rendering Data Storage SR/AR Algorithm Alarm management Patient & EquipmentManagement	PIC iX Release C.03 supports thesoftware version N.0 of theexisting IntelliVue PatientMonitor (IPM) family and thesoftware C.01 of the MX40monitor. PIC Ix Release C.03 cam showthe body sites where the Masimomeasurements (SpO2measurements) are taken can.There is no change to the Masimomeasurements themselves.	Non-significantchange. There isno new clinicalfeature added nornew riskidentified.
CommonServices	Logging Event Notification Watchdog Audit Trail User Management Licensing	Same	No change
OutboundData Services	HL7/PPIS Paging Bed to Bed Overview Web/Mobility 12 Lead Data Warehouse	With PIC iX Release C.03, thesystem scalability is increased toSupport up to 1600 beds 1600 subscriptions to adedicated web server 1600 subscriptions to adedicated mobility server two Data Warehouse Connectrepositories Currently, PIC iX sends partialalarm information to CareEventreports. PIC iX Release C.03	Non-significantchanges. There isno new clinicalfeature added.
		allows all alarm information besent to CareEvent reports.The PIC IX Release C.03 allowsuser to select which alarms from3rd party devices to display onPIC iX and propagate throughPIC iX to HL7 andCareEvent. This feature have noimpact to the 3rd party devices.The alarms are always availableon the 3rd party devices PIC iX Release C.03 enables 3rdparty devices to do HL7 export ofalarm limit information through itto EMR, in addition to thecurrently available function ofpassing numerical data.
Platform	Windows 8.1 OS Windows Server 2012 R2	Windows 10 IoT Enterprise 2016LTSBWindows Server 2016	MS OS update.
PatientMonitoringDatabase	Database Database Access	Same	No Change
DataAcquisitionServices	MDIL TeleMDIL Network Services	The PIC iX Release C.03 furtherimproves the cybersecurity, includingPIC iX-to-PIC iX Encryption andNode, Authentication and STIGimplementation.	Cybersecurityimprovement.
Reporting	Printing Recording	With PIC iX Release C.03, user canselect printers to print informationfrom PIC iX.	Minor SWenhancement.

Table 1: Comparison Table

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M3290B PIC iX Release C.03

510(k) Summary

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M3290B PIC iX Release C.03

510(k) Summary

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M3290B PIC iX Release C.03

7. Nonclinical Performance Data

The M3290B Patient Information Center iX software Release C.03 was tested in accordance with Philips verification and validation processes.

Quality Assurance measures were applied to the system design and development, including:

o Risk Analysis

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Product Specifications
Design Reviews ●
Verification & Validations ●

8. Clinical Data

Clinical Performance testing for M3290B Philips Patient Information Center iX software Release C.03 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.

9. Conclusion

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, safety testing from hazard analysis and the non-clinical testing which complied with the requirements specified in the international and FDA-recognized consensus standards. Risk assessment was conducted to identify potential hazards, to estimate and to mitigate the risks. The identified risk control measures have been implemented, verified. and finally evaluated. The identified risks have been found to be reduced to an acceptable level. The testing and the risk controls demonstrate the subject device is as safe, as effective and performs as well as its predicate devices without raising any new safety and/or effectiveness concerns. Therefore, M3290B Patient Information Center iX software Release C.03 is substantially equivalent to the legally marketed predicate device Philips M3290B Patient Information Center iX software Release C.01 (K163584) in terms of design features, fundamental scientific technology, intended use, and safety and effectiveness.

Regulation Number and Section

§ 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.