(173 days)
Not Found
No
The document describes a central monitoring station software that displays, records, and alarms based on physiological data. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on data display, storage, and alarm annunciation based on pre-defined parameters.
No
The device is described as "central station software" that displays and provides information from other medical devices. It is indicated for central monitoring and alarm annunciation, which are primarily informational and monitoring functions, not direct therapeutic interventions.
Yes
The device is indicated for central monitoring to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, which are all characteristics of a diagnostic device.
Yes
The device is described as "central station software that runs on off-the-shelf Windows PCs and servers" and its function is to display, format, and manage data from other networked medical devices. While it connects to hardware (PCs, servers, recorders, patient monitors), the device itself is explicitly defined as software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use focuses on displaying, formatting, and providing alarms for physiologic data (waves, parameters, trends) from networked medical devices connected to patients. This is related to monitoring the patient's vital signs and physiological state in vivo.
- Device Description: The description reinforces this by stating it displays physiologic waves and parameters from patient-connected monitors and telemetry devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a disease or condition based on the analysis of such samples. IVDs are specifically designed for testing samples outside the body (in vitro).
The device is a central monitoring system for patient physiological data, which falls under the category of patient monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
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.
Rx Only
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
multiple adult and all pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients; and adult, pediatric, and neonatal patients
Intended User / Care Setting
health care facilities by trained healthcare professionals. This product is not intended for home use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 870.1025 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.
0
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
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,
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
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.
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 Systems
3000 Minuteman Road
Andover, MA 01810 USA |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | 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 |
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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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
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
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.
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
| Comparative
Characteristic | Predicate: M3290B IntelliVue
Information Center Software Release
B.01 (K143057) | Proposed Device:
M3290B Philips IntelliVue Information
Center iX Software Release C.0 |
|-------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data Acquisition
Services | IntelliVue family of patient monitors | Added Efficia
Release C.0 allows data from the Philips
Efficia monitors to be received, stored,
exported and managed. |
| Outbound Data
Services | Web/Mobility
PDX | Web/Mobility
Release C.0 allows for transmission of a
web interface to the IntelliVue bedside
monitors to be opened in a window where
the bedside monitor has the capability to
use this feature.
PDX – Data Warehouse
Release C.0 expanded the ability to store
data sets from various additional sources
and the storage of complex data. |
| Applications | Surveillance
Display Set Up
Alarm Measurement & Device Control | Surveillance
Release C.0 added to the already presented
information for the Early Warning Score
(EWS) sent from the IntelliVue bedside
monitor.
Display Setup
Release C.0 added the ability, when
configured, to auto assign a bed label to a. |
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Image /page/6/Picture/0 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, providing a strong contrast that makes the word stand out.
510(k) Summary
| Comparative
Characteristic | Predicate: M3290B IntelliVue
Information Center Software Release
B.01 (K143057) | Proposed Device:
M3290B Philips IntelliVue Information
Center iX Software Release C.0 |
|-------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | sector to support the limited configuration
option for Philips Efficia monitors. |
| | | Alarm Measurement and Device Control
Release C.0 added the ability to display the
integration of the Philips Efficia monitor in
a way similar to the IntelliVue monitor. |
| Domain Specific
Services | Patient & Equipment Management
ST/AR | Patient and Equipment Management
Release C.0 adds to equipment
management the management association,
to aid in the management of 'orphan beds'.
ST/AR
Release C.0 allows data previously gathered
by the algorithm to be displayed. No
changes 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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Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
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.