Philips Hemodynamic Application R1.0

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 7, 2018 Philips Medical Systems Nederland B.V. Owen Callaghan Regulatory Affairs Manager Veenpluis 4-6 5684 PC Best, The Netherlands Re: K181311 Trade/Device Name: Philips Hemodynamic Application R1.0 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: August 6, 2018 Received: August 8, 2018 Dear Owen Callaghan: 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). 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Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181311 Device Name Philips Hemodynamic Application R1.0 ### Indications for Use (Describe) The Philips Hemodynamic Application is intended for use by professional healthcare providers for physiologic/ hemodynamic monitoring, medical data processing and analytical assessment. The software may be used to display analyze surface Electrocardiogram (ECG), Respiration. Invasive Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (ETCO2), Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), Non-Invasive Blood Pressure (NIBP), surface body Temperature and thermal Cardiac Output. The software is intended for use with other devices, such as physiological monitoring systems, information management systems, image acquisition and other medical devices. Use of the software in combination with physiological monitoring system is not intended to be used where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The software in combination with an information management system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet. The software is indicated for use in the following areas; (interventional) cardiology, electrophysiology, The Philips Hemodynamic Application is indicated for use for all human patients of all ages. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <span style="font-size:100%;"> <span style="font-family:Arial;">☒</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | <span> <span style="font-size:100%;"> <span style="font-family:Arial;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word is centered and takes up most of the frame. ## 510(k) Summary This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | May 14, 2018 | | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 | | | Primary Contact<br>Person: | Owen Callaghan<br>Regulatory Affairs Officer<br>Phone: +31 621394159<br>E-mail: owen.callaghan@philips.com | | | Secondary Contact<br>Person: | Marta Walker<br>Head of Regulatory Affairs IGT Systems<br>Phone: +31 631978546<br>E-mail: marta.walker@philips.com | | | Device: | Trade Name: Philips Hemodynamic Application R1.0<br>Classification Name: Cardiac monitor (including cardiotachometer and rate alarm)<br>Classification Regulation: 21 CFR 870.2300<br>Classification Panel: Cardiovascular<br>Device Class: Class II<br>Primary Product Code: MWI Monitor, Physiological, Patient (without Arrhythmia Detection or alarms)<br>Secondary Product Code: -- | | | Primary Predicate<br>Device: | Trade Name: Xper Flex Cardio Physiomonitoring system<br>Manufacturer: Witt Biomedical Corporation (a wholly owned subsidiary of Philips Holding USA, Inc.) latterly transferred to Invivo, a division of Philips Medica Systems<br>510(k) Clearance: K101571 (October 26, 2010)<br>Classification Name: Cardiac monitor (including cardiotachometer and rate alarm)<br>Classification Regulation: 21 CFR 870.2300<br>Classification Panel: Cardiovascular<br>Device Class: Class II | | | | Product Code: | MWI Monitor, Physiological, Patient (without<br>Arrhythmia Detection or alarms) | | Reference Device 1: | Trade Name:<br>Manufacturer:<br>510(k) Clearance:<br>Classification Name:<br>Classification Regulation:<br>Classifcation Panel:<br>Device Class:<br>Product Code: | Volcano iFR® Modality<br>Volcano Corporation, 3721 Valley Center Drive,<br>San Diego, CA 92130<br>K133323 (March 14, 2013)<br>Ultrasonic pulsed echo imaging system<br>21 CFR Part 892.1560<br>Radiology<br>Class II<br>IYO System, Imaging, Pulsed Echo, Ultrasonic | | Reference Device 2: | Trade Name:<br>Manufacturer:<br>510(k) Clearance:<br>Classification Name:<br>Classification Regulation:<br>Classifcation Panel:<br>Device Class:<br>Product Code: | Volcano iFR® ScoutTM<br>Volcano Corporation, 3721 Valley Center,<br>Drive,San Diego, CA 92130<br>K150441 (March 20, 2015)<br>Ultrasonic pulsed echo imaging system<br>21 CFR Part 892.1560<br>Radiology<br>Class II<br>IYO System, Imaging, Pulsed Echo, Ultrasonic | {4}------------------------------------------------ Device description: Philips Hemodynamic Application is a new software medical device that enables invasive investigation of cardiac and vascular disease. It will be offered as an optional accessory to the Xper Flex Cardio Physiomonitoring System, (K101571). Currently, the functionality offered by the Philips Hemodynamic Application is provided by "Hemodynamic Control Software" of the currently marketed and predicate Xper Flex Cardio Physiomonitoring System. > The software connects to the patient monitor (i.e. the Xper Flex Cardio Physiomonitoring System) and during the intervention continuously acquires realtime physiological data and alarms. In addition, Philips Hemodynamic Application provides the following functionality: - Visualize and analyze: surface ECG, Respiration rate (RR), Invasive . Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (etCO2), Noninvasive monitoring and recording of Non-Invasive Blood Pressure (NIBP), Body surface temperature (Tskin); - Provide Hemodynamic calculations: Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), thermal cardiac output parameters, valve area and valve gradient. Furthermore, Philips Hemodynamic Application also interfaces with Xper Information Management (XperIM) System (K101571) which it can transfer data to for the purpose of data collection/display, processing and patient reporting. {5}------------------------------------------------ ## PHILIPS The Philips Hemodynamic Application, provided as an optional accessory to Indications for Use: the Philips Xper Flex Cardio Physiomonitoring System, has the following indications for use: > The Philips Hemodynamic Application is intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. > The software may be used to display and/or analyze surface Electrocardiogram (ECG), Respiration, Invasive Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (ETCO2), Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), Non-Invasive Blood Pressure (NIBP), surface body Temperature and thermal Cardiac Output. > The software is intended for use with other devices, such as physiological monitoring systems, information management systems, image acquisition and other medical devices. > Use of the software in combination with physiological monitoring system is not intended to be used where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. > The software in combination with an information management system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet. > The software is indicated for use in the following areas: (interventional) cardiology, electrophysiology and radiology. > The Philips Hemodynamic Application is indicated for use for all human patients of all ages. > The indications for use statement of the Philips Hemodynamic Application are similar to the indications for use of the currently marketed predicate Xper Flex Cardio Physiomonitoring System (K101571). Both devices are: - Indicated for use by professional healthcare providers for physiologic/ ● hemodynamic monitoring, medical data processing and analytical assessment. - . Indicated for use in the following areas: (interventional) cardiology, electrophysiology and radiology. - Not intended to be used where unattended patient monitoring is desired, or in ● situations where arrhythmia detection is required. - Indicated for use for all human patients of all ages. The Indications for Use of Philips Hemodynamic Application have been further detailed by adding a description of the iFR feature. Addition of this functionality does not raise any new question of safety and effectiveness since Philips Hemodynamic Application still has the same intended use as the predicate, namely for use by professional healthcare providers for complete physiologic/hemodynamic monitoring. Based on the information provided above, the Philips Hemodynamic Application is considered substantially equivalent to the primary currently {6}------------------------------------------------ # PHILIPS Technological characteristics: marketed and predicate device Xper Flex Cardio Physiomonitoring System in terms of Indications for Use. Philips Hemodynamic Application employs comparable technology as implemented in the Hemodynamic Control Software module which is part of the Xper Flex Cardio Physiomonitoring System software. The technical similarities are such that both devices: - Provide visualization of physiology waveforms and/or values (surface ECG, ● respiration rate, invasive blood pressure, non-invasive blood pressure, pulse oximetry, end tidal CO2, body surface temperature). - . Provide user interface to display acquired physiological waveforms and values. - . Implement algorithms for hemodynamic calculations: Fractional Flow Reserve (FFR), thermal cardiac output parameters, valve area and valve gradient. - . Allow for the setting of alarm limits (upper/lower) and show visual alarms on the host PC. The Philips Hemodynamic Application provides the capability to set limits and visualize alarms, however it still requires the predicate to produce the audible alarm. - Provides a feature such that samples of the live monitoring can be captured. - Have X-ray system integration which allows table side operation via the touch screen module. - . Interfaces with the cleared Xper Information Management (XperIM) System (K101571), enabling data to be transferred for the purpose of patient data management. The Philips Hemodynamic Application implements the iFR algorithm for invasive blood pressure measurement (iFR spot and pullback) which is not present in the currently marketed predicate. These measurements are identical to the reference devices Volcano iFR® Modality and Volcano iFR® Scout™. This extends the existing Fractional Flow Reserve (FFR) functionality which uses hyperemic agent. This difference and the ones outlined above do not raise any new questions regarding safety and effectiveness. Based on the information provided above, the Philips Hemodynamic Application is considered substantially equivalent to the primary currently marketed and predicate device Xper Flex Cardio Physiomonitoring System in terms of fundamental scientific technology. {7}------------------------------------------------ # PHILIPS Summary of Non-Data: Non-clinical performance testing has been performed on Philips Hemodynamic Clinical Performance Application and demonstrates compliance with the following FDA recognized consensus standards and FDA guidance document(s): - IEC 62304 Medical device software Software life cycle processes (Edition ● 1.1, 2015-06). FDA/CDRH recognition number 13-79. - IEC 62366-1 Medical devices Part 1: Application of usability engineering . to medical devices (Edition 1.0, 2015-02). FDA/CDRH recognition number 5-114. - ISO 14971 Medical devices Application of risk management to medical ● devices (Edition. 2.0, 2007). FDA/CDRH recognition number 5-40, - ISO15223-1 Medical devices Symbols to be used with medical device ● labels, labelling and information to be supplied - Part 1: General requirements (Edition 3, 2016-11). FDA/CDRH recognition number 5-117, - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337), - Guidance for Industry and FDA Staff Applying Human Factors and ● Usability Engineering to Medical Devices, February 3, 2016 (document number 1757) - . "Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2, 2014 (document number 1825), - . "Guidance for Industry, FDA Reviewers and Compliance on – Off-The-Shelf Software Use in Medical Devices", September 9, 1999 (document number 585). - "Guidance for Industry and FDA Staff The 510(k) Program: Evaluating . Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014 (document number 1766). Non-clinical software verification testing has been performed to verify that all requirements of the System Requirements Specification, User Interaction Design as well as the identified safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements for Philips Hemodynamic Application have been implemented. Algorithm verification was performed using calibrated simulator tools that confirmed the algorithm was correctly implemented in the product. Results demonstrated that all executed verification tests were passed. Software validation testing has been performed to validate that Philips Hemodynamic Application conforms to its intended use, claims and user needs. The validation consisted of the following activities: - Usability validation was performed with both cardiologists and monitoring . nurse/technicians in a simulated use environment in a simulated environment. Philips Hemodynamic Application found to be safe and effective for the intended use, users and use environment; - In-house simulated use design validation was performed with experienced . Clinical Marketing specialists that fulfill the intended user profile. The participants executed validation protocols in the form of a device workflow {8}------------------------------------------------ # PHI | | to validate user needs, intended use and effectiveness of the safety and<br>security related measures. As part of the validation, the implemented<br>algorithms were evaluated as part of the workflow. Results demonstrated that<br>all executed validation protocols were passed. | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | All these tests were used to support substantial equivalence of the subject device<br>and demonstrate that <b>Philips Hemodynamic Application</b> :<br>• complies with the aforementioned international and FDA-recognized<br>consensus standards and FDA guidance documents, and<br>• meets the acceptance criteria and is adequate for its intended use. | | | Based on the information provided above, <b>Philips Hemodynamic Application</b><br>is substantially equivalent to the currently marketed predicate device <i>Xper Flex<br/>Cardio Physiomonitoring System</i> in terms of safety and effectiveness. | | <b>Summary of Clinical<br/>Performance Data:</b> | <b>Philips Hemodynamic Application</b> did not require a clinical study since<br>substantial equivalence to the currently marketed predicate device <i>Xper Flex<br/>Cardio Physiomonitoring System</i> was demonstrated with the following attributes:<br>• Indication for use;<br>• Technological characteristics;<br>• Non-clinical performance testing, including safety and effectiveness. | | | The verification and validation test results of <b>Philips Hemodynamic Application</b><br>described above support the safety and effectiveness of the product. It conforms<br>to the intended use, the user needs and the claims and is therefore considered<br>substantially equivalent to the currently marketed predicate device <i>Xper Flex<br/>Cardio Physiomonitoring System</i> . | | <b>Substantial<br/>Equivalence<br/>Conclusion:</b> | <b>Philips Hemodynamic Application</b> is substantially equivalent to the currently<br>marketed predicate device <i>Xper Flex Cardio Physiomonitoring System</i> in terms<br>of indications for use, technological characteristics and safety and effectiveness. | | | Additionally, substantial equivalence was demonstrated by non-clinical<br>performance tests provided in this 510(k) premarket notification. These tests<br>demonstrate that <b>Philips Hemodynamic Application</b> complies with the user<br>need requirements as well as the requirements specified in the international and<br>FDA-recognized consensus standards and is as safe and effective as its predicate<br>device and does not raise any new safety and/or effectiveness concerns. |