M3290B Philips IntelliVue Information Center iX by PHILIPS MEDICAL SYSTEMS

Indicated for central monitoring of multiple adult, pediatric, and neonatal 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.

Device Description

The Philips IntelliVue Information Center iX Software Revision B.01 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

This 510(k) premarket notification for the M3290B Philips IntelliVue Information Center iX Software Release B.01 does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The document primarily focuses on establishing substantial equivalence to a predicate device (M3290B IntelliVue Information Center software, Release A.0, marketed pursuant to K102495) based on shared indications for use and technological characteristics.

Instead, the document states:
"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."

This indicates that internal testing was conducted against existing specifications (presumably for the predicate device) to verify performance. However, the specific acceptance criteria, the detailed results, and the methodology of these tests are not provided in this summary.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, with limitations:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection). The document generalizes: "Pass/Fail criteria were based on the specifications cleared for the predicate device."
Reported Device Performance: Not explicitly provided with specific numbers. The document states: "test results showed substantial equivalence. The M3290B IntelliVue Information Center Software meets all defined reliability requirements and performance claims."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified in the document.

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)

Not specified in the document. The general nature of a "central station software" suggests the ground truth for internal performance testing might be based on established medical standards or reference equipment, rather than direct expert labeling for each data point in the way an AI diagnostic algorithm might.

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

Not specified in the document.

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 is not mentioned. This device is a central station software for displaying physiological data and generating alarms, not an AI-assisted diagnostic tool in the typical sense that would undergo MRMC studies for improved human reader performance.

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

The document implies standalone testing was performed to verify "system level tests, performance tests, and safety testing," but details on what constitutes "standalone performance" in this context (e.g., specific event detection accuracy) are not provided. Given it's a central monitoring system with alarm functions, its "standalone" performance would likely relate to its ability to correctly process and display data and trigger alarms according to predefined thresholds.

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

Not specified. For a physiological monitor, ground truth would typically come from known calibrated inputs, reference measurements, or established medical standards for event detection.

8. The sample size for the training set

Not applicable as this is a software update to an existing monitoring system, not a new AI algorithm that uses a "training set" in the machine learning sense. The testing likely involved verification and validation against functional specifications.

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

Not applicable (see point 8).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

December 3, 2014

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

Re: K143057

Trade/Device Name: M3290B Philips Intellivue Information Center iX Software Release B.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, DSH, DSI, MLD, MSX, OUG Dated: November 6, 2014 Received: November 7, 2014

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.

Melissa A. Torres -S

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

Enclosure

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ODE Indications Statement

Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/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 Monitoring Quality & Regulatory Group 3000 Minuteman Road Mailstop 0480 Andover, MA 01810 Tel: (978) 659-3000 Fax: (978) 685-5624

This summary of 510(k) information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

The submitter of this premarket notification is:

Theresa Poole Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099

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

This summary was prepared on 3 December 2014.

The name of this device is the M3290B Philips IntelliVue Information Center iX software Revision B.01 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

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The M3290B Philips IntelliVue Information Center iX (PIC iX) Release B.01 software is substantially equivalent to the previously cleared M3290B IntelliVue Information Center software, Release A.0 marketed pursuant to K102495.

The device has the same Indications for Use and Intended Use Statement as the legally marketed predicate devices.

The device has the same technological characteristics as the legally marketed predicate devices.

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 IntelliVue Information Center Software meets all defined reliability requirements and performance claims.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).