(265 days)
Not Found
No
The document describes standard physiological monitoring techniques (pulse contour analysis, thermodilution, oximetry) and does not mention AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables." It is used for monitoring purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables."
No
The device description explicitly lists hardware components (PulsioFlex Monitor, PiCCO Module, CeVOX Optical Module, ProAQT Sensor) and the performance studies include hardware-specific testing (visual, dimensional, handling, lifetime, ISO standards for physical characteristics, electrical safety, biocompatibility, sterilization, shelf-life).
Based on the provided information, the PulsioFlex Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- PulsioFlex Function: The PulsioFlex Monitoring System directly measures and monitors physiological parameters within the patient's body (blood pressure, cardiac output, venous oxygen saturation) using sensors and modules connected to the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the system as a "diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables" and is indicated for patients where "cardiovascular and circulatory volume status monitoring is necessary." This aligns with in-vivo monitoring, not in-vitro analysis of specimens.
- Device Description: The components listed (Monitor, PiCCO Module, CeVOX Optical Module, ProAQT Sensor) are all designed for direct patient connection and measurement.
- Anatomical Site: The anatomical sites mentioned (Arterial, Central Venous, Mixed Venous) are locations within the patient's circulatory system where the sensors are placed for direct measurement.
Therefore, the PulsioFlex Monitoring System is a patient monitoring system that performs in-vivo measurements, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed.
- With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.
- With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.
- With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring.
The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.
Product codes (comma separated list FDA assigned to the subject device)
DXG
Device Description
The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components:
a) PulsioFlex Monitor
b) PiCCO Module
c) CeVOX Optical Module
d) ProAQT Sensor
The PulsioFlex Monitor receives incoming signals from the patient through the connections with the modules and the accessories applied to the patient. The measurement hardware in the PulsioFlex Monitoring System provides the PulsioFlex host application (software) all data from the modules via USB protocol. The algorithms embedded in the monitor host application process the signals and provide parameter calculations. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed.
a) The PulsioFlex Monitor displays various hemodynamic parameters depending on which module(s) is/are connected, i.e. the touch screen graphical user interface (GUI) is adaptable and automatically detects what modules are connected.
b) The PulsioFlex Monitor with the PiCCO Module provides the possibility to monitor cardiac output, both continuously (pulse contour analysis) and intermittently (thermodilution).
c) The PulsioFlex Monitor together with the CeVOX Optical Module continuously measures central venous oxygen saturation or mixed venous oxygen saturation depending on the position of the fiber optic oximetry probe. In combination with continuous cardiac output and by entering a value for arterial oxygen saturation and hemoglobin additional parameters can be calculated.
d) The PulsioFlex Monitor with the ProAQT Sensor determines the cardiac output by means of pulse contour analysis. The ProAQT Sensor is connected in series to a pre-installed blood pressure measurement system. The required blood pressure data is measured and transferred to the PulsioFlex Monitor that analyzes the data and calculates and displays the associated parameters.
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
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Intended User / Care Setting
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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)
Performance Data: The following verification activities were performed in support of a substantial equivalence determination.
Performance Testing: Technical and functional requirements for the ProAQT Sensor have been verified within performance testing for the changes. The following verifications were conducted:
- Visual, dimensional and handling tests
- Lifetime test
- Verification of required product characteristics
- Tests according to ISO 594-1:1986 and ISO 594-2:1998 requirements
- Tests according to ANSI/AAMI BP22 requirements
- Tests according to ISO 11607-1 requirements
Software verification: The PulsioFlex Monitoring System's software is considered a Moderate Level of Concern. Software verification was performed considering FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and according to the standard IEC 62304 "Medical device software - Software life-cycle processes".
Electrical Safety and Electromagnetic Compatibility (EMC): The PulsioFlex Monitoring System with ProAQT is tested to be in compliance with the following standards: IEC 60601-1 (with US deviation according to AAMI/ANSI ES60601-1:2005/(R) 2012), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 62366-1, IEC 60601-2-34, and IEC 60601-2-49.
Sterilization Validation: The sterility is assured by an EO (Ethylene Oxide) sterilization of the product within the unopened and undamaged packaging. Tests demonstrate that the sterilization process and equipment are capable of reliably and consistently sterilizing to a minimum Sterility Assurance Level (SAL) of 10-6. The sterilization process was validated according to ISO 11135 requirements and revalidated according to the overkill / cycle calculation approach described in ISO 11135:2014. Residuals were evaluated by exhaustive extraction according to ISO 10993-7:2009.
Biocompatibility: The biocompatibility evaluation for the ProAQT Sensor was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The following toxicological endpoints are considered:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity / Irritation
- Acute Systemic Toxicity
- Material-mediated Pyrogenicity
- Subacute / Subchronic Toxicity
- Hemocompatibility
Shelf-Life Testing: Accelerated and real time aging was conducted to demonstrate 36 months (3 years) of shelf life. The study was conducted with increments of 18 and 36 months. The results for both increments after accelerated aging, as well as after real time aging of 36 months, demonstrate that the ProAQT Sensor fulfills this requirement. It is concluded that a shelf life of 36 months is verified by the available data.
Usability Testing: A Summative Usability Evaluation was performed considering FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices" and according to the standard IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices". The PulsioFlex Monitoring System with ProAQT Sensor has been found to be safe and effective for the intended users, uses, and use environments.
Non-Clinical Performance: Completion of all verification activities demonstrated that the subject device meets all design and performance requirements. Verification activities performed confirmed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.
Clinical Performance: Clinical data demonstrates that the pulse contour algorithm is able to process pressure signals from femoral, brachial, axillary and also radial artery adequately.
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
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows 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.
April 30, 2019
Pulsion Medical Systems SE % Mark Smith Manager, Regulatory Affairs Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K192169
Trade/Device Name: PulsioFlex Monitoring System with ProAQT Sensor Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: March 31, 2020 Received: April 1, 2020
Dear Mark Smith:
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
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192169
Device Name
PulsioFlex Monitoring System with ProAQT Sensor
Indications for Use (Describe)
The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed.
-
With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.
-
With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.
-
With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring.
The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.
| 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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GETINGE *
K192169 1 (8)
510(K) SUMMARY
Prepared in accordance with 21 CFR Part 807.92
| Date Prepared | August 06, 2019 |
|---|---|
| Device Owner | PULSION Medical Systems SE |
| Hans-Riedl-Str. 17 | |
| 85622 Feldkirchen | |
| Germany | |
| Contact Personnel | Mr. Mark Smith |
| Regulatory Affairs | |
| mark.n.smith@getinge.com | |
| Phone | (585) 272-5274 |
| Fax | (585) 272-5066 |
| System Name | PulsioFlex Monitoring System with ProAQT |
| Trade name(s) | PulsioFlex Monitor |
| PiCCO Module | |
| CeVOX Module | |
| ProAQT Sensor | |
| Device Generic | |
| Name | Single-function, pre-programmed diagnostic |
| computer. | |
| Classification | According to 21 CFR 870.1435 the device classification is Class II, |
| Product code DXG. | |
| Predicate Device | K172259, PulsioFlex Monitoring System |
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- The PulsioFlex Monitoring System is a diagnostic aid for the Intended Use measurement and a monitoring of of blood o pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed.
- . With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.
- . With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.
- -With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring.
- Indications for Use The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful.
This includes patients in surgical, medical, and other hospital units.
- Device Description The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components:
- a) PulsioFlex Monitor
- b) PiCCO Module
- c) CeVOX Optical Module
- d) ProAQT Sensor
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Description of functionality
The PulsioFlex Monitor receives incoming signals from the patient through the connections with the modules and the accessories applied to the patient. The measurement hardware in the PulsioFlex Monitoring System provides the PulsioFlex host application (software) all data from the modules via USB protocol. The algorithms embedded in the monitor host application process the signals and provide parameter calculations. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed.
Description of the components
- a) The PulsioFlex Monitor displays various hemodynamic parameters depending on which module(s) is/are connected, i.e. the touch screen graphical user interface (GUI) is adaptable and automatically detects what modules are connected.
- b) The PulsioFlex Monitor with the PiCCO Module provides the possibility to monitor cardiac output, both continuously (pulse contour analysis) and intermittently (thermodilution). A comprehensive list of parameters (absolute and indexed to patient biometric data) available while monitoring with the PulsioFlex Monitor connected to the PiCCO Module is shown below.
Thermodilution
| Parameter | Abbr. | Index |
|---|---|---|
| Cardiac Output, transpulmonary | tdCO | tdCI |
| Global End-Diastolic Volume | GEDV | GEDI |
| Extravascular Lung Water | EVLW | ELWI |
| Cardiac Function Index | CFI | |
| Global Ejection Fraction | GEF | |
| Pulmonary Vascular Permeability Index | PVPI | |
| Intrathoracic Blood Volume | ITBV | ITBI |
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Pulse Contour Analysis
| Parameter | Abbr. | Index |
|---|---|---|
| Heart Rate | HR | |
| Mean Arterial Blood Pressure | MAP | |
| Central Venous Pressure | CVP | |
| Systolic Arterial Blood Pressure | APsys | |
| Diastolic Arterial Blood Pressure | APdia | |
| Pulse Contour Cardiac Output (*) | COPC | CIPC |
| Stroke Volume | SV | SVI |
| Systemic Vascular Resistance | SVR | SVRI |
| Stroke Volume Variation | SVV | |
| Pulse Pressure Variation | PPV | |
| Cardiac Power Output | CPO | CPI |
- c) The PulsioFlex Monitor together with the CeVOX Optical Module continuously measures central venous oxygen saturation or mixed venous oxygen saturation depending on the position of the fiber optic oximetry probe. In combination with continuous cardiac output and by entering a value for arterial oxygen saturation and hemoglobin additional parameters can be calculated. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed. A comprehensive list of parameters available while monitoring with the PulsioFlex Monitor with the connected CeVOX Optical Module and a fiber optic oximetry probe are listed below.
| Parameter | Abbr. | Index |
|---|---|---|
| Central Venous Oxygen Saturation | ScvO2 | |
| Venous Oxygen Saturation | SvO2 | |
| Oxygen Delivery | DO2 | DO2I |
| Oxygen Consumption | VO2 | VO2I |
| Oxygen Extraction Ratio | O2ER |
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- d) The PulsioFlex Monitor with the ProAQT Sensor determines the cardiac output by means of pulse contour analysis. The ProAQT Sensor is connected in series to a pre-installed blood pressure measurement system. The required blood pressure data is measured and transferred to the PulsioFlex Monitor that analyzes the data and calculates and displays the associated parameters. A comprehensive list of parameters (absolute and indexed to patient biometric data) available while monitoring with the PulsioFlex Monitor connected to the ProAQT Sensor is shown below.
Pulse Contour Analysis
| Parameter | Abbr. | Index |
|---|---|---|
| Heart Rate | HR | |
| Mean Arterial Blood Pressure | MAP | |
| Central Venous Pressure | CVP | |
| Systolic Arterial Blood Pressure | APsys | |
| Diastolic Arterial Blood Pressure | APdia | |
| Pulse Contour Cardiac Output (*) | COCal | CICal |
| Stroke Volume | SV | SVI |
| Stroke Volume Variation | SVV | |
| Pulse Pressure Variation | PPV | |
| Cardiac Power Output | CPO | CPI |
(*) Subscripts "cal" and "pc" are used to distinguish between different calibration methods for pulse contour analysis:
-
"pc": Calibration with CO from thermodilution
-
"cal": Calibration with CO from user input using an external measurement method
Comparison to The PulsioFlex Monitoring System with ProAQT Sensor uses the same monitoring technology, the same measured parameters Predicate Device and the same default alarm limits as the predicate device PulsioFlex Monitoring System (K172259).
Updates made to the PulsioFlex Monitoring System with ProAQT include:
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■ Inclusion of the use of the ProAQT Sensor
The use of the ProAQT Sensor allows the PulsioFlex Monitoring System to use only arterial pulse contour analysis for continuous hemodynamic monitoring.
I PulsioFlex Monitor - Software
The software was updated to V5.2 due to necessary adaptations related to the cardiac output calibration with the ProAQT Sensor. Specifically for the ProAQT Sensor, externally derived cardiac output (e.g. by doppler ultrasound technique) serves as calibration input. The arterial blood pressure signal from the ProAQT Sensor uses the identical algorithm as the PiCCO Technology.
Performance and compatibility of the ProAQT Sensor with the PulsioFlex Monitor has been successfully verified.
- Performance Data The following verification activities were performed in support of a substantial equivalence determination.
Performance Testing
Technical and functional requirements for the ProAQT Sensor have been verified within performance testing for the changes. The following verifications were conducted:
- Visual, dimensional and handling tests ●
- Lifetime test
- Verification of required product characteristics ●
- Tests according to ISO 594-1:1986 and ISO 594-2:1998 requirements
- Tests according to ANSI/AAMI BP22 requirements
- Tests according to ISO 11607-1 requirements
Software verification
The PulsioFlex Monitoring System's software is considered a Moderate Level of Concern. Software verification was performed considering FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and according to the standard IEC 62304 "Medical device software - Software life-cycle processes".
9
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Electrical Safety and Electromagnetic Compatibility (EMC)
The PulsioFlex Monitoring System with ProAQT is tested to be in compliance with the following standards: IEC 60601-1 (with US deviation according to AAMI/ANSI ES60601-1:2005/(R) 2012), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 62366-1, IEC 60601-2-34, and IEC 60601-2-49.
Sterilization Validation
The sterility is assured by an EO (Ethylene Oxide) sterilization of the product within the unopened and undamaged packaging. Tests demonstrate that the sterilization process and equipment are capable of reliably and consistently sterilizing to a minimum Sterility Assurance Level (SAL) of 106. The sterilization process was validated according to ISO 11135 requirements and revalidated according to the overkill / cycle calculation approach described in ISO 11135:2014. Residuals were evaluated by exhaustive extraction according to ISO 10993-7:2009.
Biocompatibility
The biocompatibility evaluation for the ProAQT Sensor was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The following toxicological endpoints are considered:
- Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity / Irritation
- Acute Systemic Toxicity ●
- Material-mediated Pyrogenicity
- Subacute / Subchronic Toxicity
- Hemocompatibility
Shelf-Life Testing
Accelerated and real time aging was conducted to demonstrate 36 months (3 years) of shelf life. The study was conducted with increments of 18 and 36 months.
The results for both increments after accelerated aging, as well as after real time aging of 36 months, demonstrate that the ProAQT
10
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Sensor fulfills this requirement. It is concluded that a shelf life of 36 months is verified by the available data.
Usability Testing
A Summative Usability Evaluation was performed considering FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices" and according to the standard IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices". The PulsioFlex Monitoring System with ProAQT Sensor has been found to be safe and effective for the intended users, uses, and use environments.
- Non-Clinical Completion of all verification activities demonstrated that the Performance subject device meets all design and performance requirements. Verification activities performed confirmed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.
- Clinical Clinical data demonstrates that the pulse contour algorithm is able to Performance process pressure signals from femoral, brachial, axillary and also radial artery adequately.
- Conclusion The PulsioFlex Monitoring System with ProAQT Sensor is substantially equivalent to the legally marketed predicate PulsioFlex Monitoring System (K172259).