The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database.

An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

This product is intended for use in health care facilities by trained healthcare professionals. This product is not intended for home use.

Indications for Use

Indicated for central monitoring of multiple adult and all pediatric subgroups (Newborn (neonate). Infant, Child, Adolescent) patients; and where the clinician decides to monitor cardiac arthythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Description

The Philips IntelliVue Information Center iX Software Revision C.O is central station software that runs on off-the-shelf Windows PCs and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.

AI/ML Overview

The provided FDA 510(k) summary for the Philips IntelliVue Information Center iX (K153702) discusses software changes but does not contain detailed information about specific acceptance criteria, device performance, or a study rigorously proving the device meets new acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K143057) through non-clinical testing of design, functionality, and reliability, rather than clinical performance for new applications.

The document explicitly states: "Clinical Performance testing for M3290B Philips IntelliVue Information Center iX software Release C.0 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, I cannot populate the requested tables and sections with specific acceptance criteria and performance data for this particular 510(k) application, as such detailed information is not present in the provided text. The submission relies on demonstrating that the software updates do not introduce new safety or effectiveness concerns compared to the already cleared predicate device.

However, based on the non-clinical testing performed and the general approach of a 510(k) summary seeking substantial equivalence, I can describe what would typically be the nature of the acceptance criteria and study in such a scenario, by interpreting the information given and stating what is not present.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the Philips IntelliVue Information Center iX (K153702) focuses on demonstrating substantial equivalence to a predicate device (K143057) for software updates. It explicitly states that clinical performance testing was not performed because no new clinical applications or significant new hazards/risks were introduced that would necessitate it. Therefore, the "acceptance criteria" here are primarily tied to verifying that the updated software maintains the safety, effectiveness, functionality, and reliability characteristics of the predicate device, as confirmed through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical performance study was conducted for new clinical applications, specific numerical performance metrics (e.g., sensitivity, specificity for arrhythmia detection) are not reported for this particular 510(k) submission. The acceptance criteria and "performance" are framed around maintaining equivalence to the predicate device.

Acceptance Criterion (Implied/General)	Reported Device Performance (as per document)
Functional Equivalence	- Data acquisition from Philips Efficia monitors (new).- Transmission of web interface to IntelliVue bedside monitors (new/expanded outbound data services).- Expanded ability to store complex data sets from various additional sources (PDX Data Warehouse).- Integration of Early Warning Score (EWS) information from bedside monitors (new/expanded application).- Auto-assignment of bed labels when configured.- Display of Philips Efficia monitor integration similar to IntelliVue.- Management association for 'orphan beds' in patient and equipment management.- Display of previously gathered ST/AR algorithm data (no changes to algorithm).
Reliability and Stability	- Verification, validation, and testing activities, including system level tests, performance tests, and safety testing from hazard analysis.- Test results showed substantial equivalence, meeting all defined reliability requirements and performance claims based on specifications cleared for the predicate device.
Safety	- Risk Analysis conducted.- Design Reviews conducted.- Testing involved safety testing from hazard analysis.- No new safety and/or effectiveness concerns were identified compared to the predicate device.
Performance Standards	- Compliance with Philips verification and validation processes.- Pass/Fail criteria based on specifications cleared for the predicate device.- Compliance with requirements specified in international and FDA-recognized consensus standards.
Clinical Performance (New Risks)	- Clinical performance testing not performed as no new clinical applications with hazards or risk mitigations requiring it were identified. The device's clinical performance is thereby considered equivalent to the predicate, which would have established such performance in its own clearance.

2. Sample Size for Test Set and Data Provenance

Test Set Sample Size: Not specified in the provided document. The testing was non-clinical, likely involving various software modules and integration points rather than a "test set" of patient data in the conventional sense for clinical performance.
Data Provenance: Not applicable in the context of clinical patient data for this submission, as the testing was non-clinical (engineering verification and validation).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable, as the testing was non-clinical. Ground truth for software functionality, reliability, and safety is typically established against design specifications, recognized standards, and hazard analyses, rather than clinical expert consensus on patient data.
Qualifications of Experts: Not specified. Testing would have been conducted by Philips' internal engineering, quality assurance, and regulatory teams.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no clinical ground truth requiring adjudication was established for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. An MRMC study is a clinical study involving multiple human readers interpreting cases to assess diagnostic performance. This submission explicitly states "Clinical Performance testing... was not performed."

6. Standalone Performance Study (Algorithm only)

Standalone Performance Study Done: No, not in the sense of a new clinical algorithm being evaluated for its standalone diagnostic performance. The document mentions "Release C.0 allows data previously gathered by the algorithm [ST/AR] to be displayed. No changes to the algorithm are present." This indicates that existing algorithms (like ST/AR for arrhythmia/ST segment analysis) were unchanged, and their performance would have been established in previous 510(k) clearances for the predicate device. The focus here is on the information center's ability to process and display that data.

7. Type of Ground Truth Used

Type of Ground Truth: For the non-clinical testing performed, the ground truth was based on:
- Product Specifications: Meeting defined requirements.
- Design Specifications: Adherence to engineered design.
- Hazard Analysis: Ensuring risks are mitigated and safety maintained.
- Predicate Device Specifications: Ensuring equivalence in performance and functionality to the device previously cleared.
- International and FDA-recognized Consensus Standards: Compliance with industry benchmarks.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This submission concerns software updates to a central monitoring system, not the development of new machine learning algorithms requiring a training set of data. Existing algorithms (like ST/AR) maintain their previously established performance and would have been "trained" (or validated) in earlier submissions if they involved such methodologies.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable, as no new training set was used for this submission.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 13, 2016

Philips Medical Systems Theresa Poole Regulatory Specialist 3000 Minuteman Road Andover, Massachusetts 01810

Re: K153702

Trade/Device Name: M3290b Philips Intellivue 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, DSH, MSX, OUG Dated: Mav 4, 2016 Received: May 9, 2016

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

[signature]

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K153702

Device Name

M3290B Philips IntelliVue Information Center iX software Release C.0

Indications for Use (Describe)

Intended Use

An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

This product is intended for use in health care facilities by trained healthcare professionals. This product is not intended for home use.

Indications for Use

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)

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Image /page/3/Picture/0 description: The image displays the Philips logo in blue, followed by the text "Philips IntelliVue Information Center iX" and "Traditional 510(k)" in black. The Philips logo is a stylized wordmark with a distinctive design. The text below the logo provides information about the product or service, indicating it is related to Philips IntelliVue and involves a Traditional 510(k) process.

510(k) Summary Philips IntelliVue Information Center iX Release C.0

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).

Date Prepared: 4 May 2016

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 01810-1099Tel: 978 659 7621Fax: 978 685 5624Email: theresa.poole@philips.com

II. Device information

Device Name: M3290B Philips IntelliVue Information Center iX software Revision C.0 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
880.6310, I	OUG	Medical Device Data System

III. Predicate device information

Trade name: M3290B Philips IntelliVue Information Center iX software Revision B.01 Manufacturer: Philips Medical Systems 510(k) clearance: K143057

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Philips IntelliVue Traditional 510

510(k) Summary

Classification name Device class: Classification requlation: Classification panel: Product code:

Central Station Class II 21 CFR 892.2300 Cardiovascular MSX

IV.Device Description

V. Intended use/ Indications for Use

Intended Use

M3290B Intended Use Intended Use Statement, as described in its labeling, has not changed from that of the predicate device. The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. This product is intended for use in health care facilities by trained healthcare professionals. This product is not intended for home use. Rx Only

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Image /page/5/Picture/0 description: The image displays the logo for Philips IntelliVue Information Center iX Traditional 510(k). The word "PHILIPS" is in large, bold, blue letters at the top. Below that, in a smaller font, is the text "Philips IntelliVue Information Center iX Traditional 510(k)".

510(k) Summary

Indications for Use

M3290B Indications for Use

The indications for use of the device, as described in its labeling, have not changed from that of the predicate device.

Indicated for central monitoring of multiple adult and all pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients: and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

VI.Comparison of Technological Characteristics with the Predicate Device

The device has the same technological characteristics as the legally marketed predicate devices. This software change include items listed in the table below

ComparativeCharacteristic	Predicate: M3290B IntelliVueInformation Center Software ReleaseB.01 (K143057)	Proposed Device:M3290B Philips IntelliVue InformationCenter iX Software Release C.0
Data AcquisitionServices	IntelliVue family of patient monitors	Added EfficiaRelease C.0 allows data from the PhilipsEfficia monitors to be received, stored,exported and managed.
Outbound DataServices	Web/MobilityPDX	Web/MobilityRelease C.0 allows for transmission of aweb interface to the IntelliVue bedsidemonitors to be opened in a window wherethe bedside monitor has the capability touse this feature.PDX – Data WarehouseRelease C.0 expanded the ability to storedata sets from various additional sourcesand the storage of complex data.
Applications	SurveillanceDisplay Set UpAlarm Measurement & Device Control	SurveillanceRelease C.0 added to the already presentedinformation for the Early Warning Score(EWS) sent from the IntelliVue bedsidemonitor.Display SetupRelease C.0 added the ability, whenconfigured, to auto assign a bed label to a.

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510(k) Summary

ComparativeCharacteristic	Predicate: M3290B IntelliVueInformation Center Software ReleaseB.01 (K143057)	Proposed Device:M3290B Philips IntelliVue InformationCenter iX Software Release C.0
		sector to support the limited configurationoption for Philips Efficia monitors.
		Alarm Measurement and Device ControlRelease C.0 added the ability to display theintegration of the Philips Efficia monitor ina way similar to the IntelliVue monitor.
Domain SpecificServices	Patient & Equipment ManagementST/AR	Patient and Equipment ManagementRelease C.0 adds to equipmentmanagement the management association,to aid in the management of 'orphan beds'.ST/ARRelease C.0 allows data previously gatheredby the algorithm to be displayed. Nochanges to the algorithm are present.

Performance Data VII.

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.0 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 ●

Summary of Clinical Testing

Clinical Performance testing for M3290B Philips IntelliVue Information Center iX software Release C.0 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

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Philips IntelliVue Infor Traditional 510(k)

510(k) Summary

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 Information Center iX software Release C.0 meets all defined reliability requirements and performance claims.

VIII. Conclusion

M3290B Philips IntelliVue Information Center iX software Release C.0 is substantially equivalent to the predicate device M3290B Philips IntelliVue Information Center iX software Release B.01 (K143057) 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.

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.