M3290B Philips IntelliVue Information Center iX

{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 {2}------------------------------------------------ # 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) | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ 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<br>3000 Minuteman Road<br>Andover, MA 01810 USA | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Theresa Poole<br>Regulatory Affairs Specialist<br>Philips Medical Systems<br>3000 Minuteman Road, MS0480<br>Andover, MA 01810-1099<br><br>Tel: 978 659 7621<br>Fax: 978 685 5624<br>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,<br>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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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<br>Characteristic | Predicate: M3290B IntelliVue<br>Information Center Software Release<br>B.01 (K143057) | Proposed Device:<br>M3290B Philips IntelliVue Information<br>Center iX Software Release C.0 | |-------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Data Acquisition<br>Services | IntelliVue family of patient monitors | Added Efficia<br>Release C.0 allows data from the Philips<br>Efficia monitors to be received, stored,<br>exported and managed. | | Outbound Data<br>Services | Web/Mobility<br>PDX | Web/Mobility<br>Release C.0 allows for transmission of a<br>web interface to the IntelliVue bedside<br>monitors to be opened in a window where<br>the bedside monitor has the capability to<br>use this feature.<br>PDX – Data Warehouse<br>Release C.0 expanded the ability to store<br>data sets from various additional sources<br>and the storage of complex data. | | Applications | Surveillance<br>Display Set Up<br>Alarm Measurement & Device Control | Surveillance<br>Release C.0 added to the already presented<br>information for the Early Warning Score<br>(EWS) sent from the IntelliVue bedside<br>monitor.<br>Display Setup<br>Release C.0 added the ability, when<br>configured, to auto assign a bed label to a. | {6}------------------------------------------------ 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<br>Characteristic | Predicate: M3290B IntelliVue<br>Information Center Software Release<br>B.01 (K143057) | Proposed Device:<br>M3290B Philips IntelliVue Information<br>Center iX Software Release C.0 | |-------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | sector to support the limited configuration<br>option for Philips Efficia monitors. | | | | Alarm Measurement and Device Control<br>Release C.0 added the ability to display the<br>integration of the Philips Efficia monitor in<br>a way similar to the IntelliVue monitor. | | Domain Specific<br>Services | Patient & Equipment Management<br>ST/AR | Patient and Equipment Management<br>Release C.0 adds to equipment<br>management the management association,<br>to aid in the management of 'orphan beds'.<br><br>ST/AR<br>Release C.0 allows data previously gathered<br>by the algorithm to be displayed. No<br>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 {7}------------------------------------------------ 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.