(40 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard central monitoring software functionalities.
No.
The device is a central monitoring software that displays physiological data and alarms, intended to inform treatment decisions, but it does not directly apply therapy or treatment to a patient.
Yes
The "Intended Use / Indications for Use" states that the device is used "to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms," which aligns with the purpose of a diagnostic device.
Yes
The device description explicitly states it is "central station software that runs on off-the-shelf Windows PCs and servers" and connects to other devices for data display and processing. It does not include any hardware components as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Philips IntelliVue Information Center iX Software is a central monitoring system that displays and processes physiological data directly from patient-connected monitors and telemetry devices. It does not analyze samples taken from the patient.
- Intended Use: The intended use describes monitoring cardiac arrhythmia and ST segments, which are physiological signals measured directly from the patient, not through in vitro analysis of samples.
Therefore, this device falls under the category of patient monitoring systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DSH, MSX, OUG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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:
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.
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 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.
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.