(113 days)
No
The summary describes standard physiological monitoring and calculation functionalities, with no mention of AI, ML, or related concepts like training/test sets.
No
Explanation: The device is intended for monitoring, data processing, and analysis, not for treatment or therapy. It explicitly states it is not for "unattended patient monitoring" or "arrhythmia detection where required," further indicating it's a diagnostic/monitoring tool, not a therapeutic one.
Yes
The device is intended for "physiologic/hemodynamic monitoring, medical data processing and analytical assessment" and provides "Hemodynamic calculations" which are used for assessment, indicating its diagnostic function.
Yes
The device description explicitly states "Philips Hemodynamic Application is a new software medical device". While it connects to and relies on other hardware devices (patient monitor, information management system), the device itself, as described, is the software application.
Based on the provided text, the Philips Hemodynamic Application is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use and Device Description: The Philips Hemodynamic Application is described as a software medical device that connects to a patient monitor to acquire and analyze real-time physiological data directly from the patient (ECG, Respiration, Blood Pressure, SpO2, ETCO2, Temperature, FFR, iFR, Cardiac Output). It processes and displays these in-vivo measurements.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient. Its function is based on direct physiological measurements.
Therefore, the Philips Hemodynamic Application falls under the category of a physiological monitoring and analysis device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI
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.
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
all human patients of all ages.
Intended User / Care Setting
professional healthcare providers
(interventional) cardiology, electrophysiology, and radiology.
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)
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 to validate user needs, intended use and effectiveness of the safety and security related measures. As part of the validation, the implemented algorithms were evaluated as part of the workflow. Results demonstrated that all executed validation protocols were passed.
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.
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).
0
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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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Stephen C. Browning -S5
for Bram D. 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 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. | |
| Veenpluis 4-6 | ||
| 5684 PC Best | ||
| The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact | ||
| Person: | Owen Callaghan | |
| Regulatory Affairs Officer | ||
| Phone: +31 621394159 | ||
| E-mail: owen.callaghan@philips.com | ||
| Secondary Contact | ||
| Person: | Marta Walker | |
| Head of Regulatory Affairs IGT Systems | ||
| Phone: +31 631978546 | ||
| E-mail: marta.walker@philips.com | ||
| Device: | Trade Name: Philips Hemodynamic Application R1.0 | |
| Classification Name: Cardiac monitor (including cardiotachometer and rate alarm) | ||
| Classification Regulation: 21 CFR 870.2300 | ||
| Classification Panel: Cardiovascular | ||
| Device Class: Class II | ||
| Primary Product Code: MWI Monitor, Physiological, Patient (without Arrhythmia Detection or alarms) | ||
| Secondary Product Code: -- | ||
| Primary Predicate | ||
| Device: | Trade Name: Xper Flex Cardio Physiomonitoring system | |
| Manufacturer: Witt Biomedical Corporation (a wholly owned subsidiary of Philips Holding USA, Inc.) latterly transferred to Invivo, a division of Philips Medica Systems | ||
| 510(k) Clearance: K101571 (October 26, 2010) | ||
| Classification Name: Cardiac monitor (including cardiotachometer and rate alarm) | ||
| Classification Regulation: 21 CFR 870.2300 | ||
| Classification Panel: Cardiovascular | ||
| Device Class: Class II | ||
| Product Code: | MWI Monitor, Physiological, Patient (without | |
| Arrhythmia Detection or alarms) | ||
| Reference Device 1: | Trade Name: | |
| Manufacturer: | ||
| 510(k) Clearance: | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classifcation Panel: | ||
| Device Class: | ||
| Product Code: | Volcano iFR® Modality | |
| Volcano Corporation, 3721 Valley Center Drive, | ||
| San Diego, CA 92130 | ||
| K133323 (March 14, 2013) | ||
| Ultrasonic pulsed echo imaging system | ||
| 21 CFR Part 892.1560 | ||
| Radiology | ||
| Class II | ||
| IYO System, Imaging, Pulsed Echo, Ultrasonic | ||
| Reference Device 2: | Trade Name: | |
| Manufacturer: | ||
| 510(k) Clearance: | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classifcation Panel: | ||
| Device Class: | ||
| Product Code: | Volcano iFR® ScoutTM | |
| Volcano Corporation, 3721 Valley Center, | ||
| Drive,San Diego, CA 92130 | ||
| K150441 (March 20, 2015) | ||
| Ultrasonic pulsed echo imaging system | ||
| 21 CFR Part 892.1560 | ||
| Radiology | ||
| Class II | ||
| 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
security related measures. As part of the validation, the implemented
algorithms were evaluated as part of the workflow. Results demonstrated that
all executed validation protocols were passed. |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All these tests were used to support substantial equivalence of the subject device
and demonstrate that Philips Hemodynamic Application :
• complies with the aforementioned international and FDA-recognized
consensus standards and FDA guidance documents, and
• meets the acceptance criteria and is adequate for its intended use. |
| | Based on the information provided above, Philips Hemodynamic Application
is substantially equivalent to the currently marketed predicate device Xper Flex
Cardio Physiomonitoring System in terms of safety and effectiveness. |
| Summary of Clinical
Performance Data: | Philips Hemodynamic Application did not require a clinical study since
substantial equivalence to the currently marketed predicate device Xper Flex
Cardio Physiomonitoring System was demonstrated with the following attributes:
• Indication for use;
• Technological characteristics;
• Non-clinical performance testing, including safety and effectiveness. |
| | The verification and validation test results of Philips Hemodynamic Application
described above support the safety and effectiveness of the product. It conforms
to the intended use, the user needs and the claims and is therefore considered
substantially equivalent to the currently marketed predicate device Xper Flex
Cardio Physiomonitoring System . |
| Substantial
Equivalence
Conclusion: | Philips Hemodynamic Application is substantially equivalent to the currently
marketed predicate device Xper Flex Cardio Physiomonitoring System in terms
of indications for use, technological characteristics and safety and effectiveness. |
| | Additionally, substantial equivalence was demonstrated by non-clinical
performance tests provided in this 510(k) premarket notification. These tests
demonstrate that Philips Hemodynamic Application complies with the user
need requirements as well as the requirements specified in the international and
FDA-recognized consensus standards and is as safe and effective as its predicate
device and does not raise any new safety and/or effectiveness concerns. |