(195 days)
Not Found
No
The document describes a patient monitor that acquires and displays physiological signals, generates alarms, and supports data management. While it includes various measurement modules and features, there is no mention of AI or ML being used for data analysis, interpretation, or decision support beyond standard physiological parameter monitoring and predefined protocols (like the SSC Sepsis Protocol, which is a clinical decision support tool but not explicitly described as AI/ML-driven). The software modifications listed are related to hardware support, GUI, electronic strip recording, and remote application support, none of which indicate AI/ML implementation.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states "Not therapeutic devices."
Yes
The text explicitly states: "The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11)." This indicates a diagnostic capability. While the device in its entirety is a monitor, certain measurements it performs are for diagnostic purposes.
No
The device description explicitly mentions hardware components like displays, touch-screens, keyboards, pointing devices, external measurement modules, and a 4-Slot Module Rack. The software modifications are described as supporting these hardware components and adding features to the overall system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the monitors are for "monitoring the physiological parameters of patients." This involves measuring signals directly from the patient's body (ECG, blood pressure, temperature, etc.).
- Device Description: The device description details the acquisition of "multiple physiological patient signals" and the display of "measurement values, waves and trends." These are all in-vivo measurements.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (blood, urine, tissue, etc.) or performing tests in vitro (in a lab setting).
In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition. It is a patient monitoring device that measures physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The 4-Slot Module rack FMX-4 is intended to connect up to four particular plug-in physiological measurement modules to the dedicated host patient monitors.
Product codes
MHX, MLD, DSJ, DSK, DXN, DRT, DPS, DQA, DSF, MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWQ, GWS, FLL
Device Description
Hardware and software modifications carried out on the legally marketed device Intelli Vue Patient Monitor MX800 and its IntelliVue 4-Slot Module Rack FMS-4, resulted in new models, the IntelliVue Patient Monitors MX750, MX850 and their 4-Slot Module Rack FMX-4, the subject of this submission.
The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.
The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, EEG, BIS, NMT, and gas analysis.
The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.
The monitor models MX750 and MX850 differ mainly in size. Whilst MX750 has a 19" flat panel display, MX850 has a 22" display.
Modifications:
Standard hardware components of the almost 10 years old predicate MX800, like flat panel display, touch screen, CPU, video board, and memory have been replaced in the MX750 and MX850 by state of the art electronic components. Two additional features, the NFC reader and adaptive lighting through the Ambient Light Sensor, have been implemented into the new MX750 and MX850 monitors.
The hardware of the new 4-Slot Module Rack FMX-4 is very similar to that of its 8 years old predicate 4-Slot Module Rack FMS-4. The new FMX-4 has the same housing, which is made of the same material as FMS-4 but has a slightly different shade of color (same shade of color as the new MX750 and MX850 monitors). The FMX-4 has a new Printed Circuit Assembly with standard hardware components like CPU and memory being replaced by state of the art electronic components.
The software modifications comprise the following changes:
- Support of the new state-of-the-art electronic components.
- Modified elements of the Graphical User Interface.
- Implementation of a feature called Electronic Strip Recording. This feature allows electronic strips that can be reviewed on the monitor and printed out as a report on the printer.
- Modification of the existing feature Remote Applications to support HTML5 and PDF format.
None of the described modifications represents any change to the fundamental technology of the predicate device.
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
Adults, pediatrics, and neonates.
ST segment monitoring: adult patients only.
BIS: adult and pediatric patients.
SSC Sepsis Protocol: adult patients only.
Integrated Pulmonary Index (IPI): adult and pediatric (1 to 12 years) patients only.
Pulse Pressure Variation (PPV): adult patients only.
NMT Module: adult and pediatric patients.
Intended User / Care Setting
Trained healthcare professionals in a hospital environment.
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)
The modified IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 with the current software Revision N.01 have been subject to the following V&V activities:
- Testing according to the recognized consensus standard:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1)
- IEC 60601-1-2:2014 (Ed. 4)
- IEC 60601-2-23:2011 (Ed.3)
- IEC 60601-2-25:2011 (Ed. 2)
- IEC 60601-2-27:2011(Ed. 3)
- IEC 80601-2-30:2009 (Ed. 1.1) and A1:2013
- IEC 60601-2-34:2011(Ed.3)
- ISO 80601-2-55:2018 (Ed. 2)
- ISO 80601-2-56:2017 (Ed. 2) and A1:2018
- ISO 80601-2-61:2017 (Ed. 2) and Corr1:2018
- IEC 60601-1-8:2006 (Ed. 2.1) and A1:2012 All applicable requirements have been met.
- Compliance with the recognized consensus process standards:
- IEC 62304:2006 (Ed. 1.1) and A1:2015
- IEC 60601-1-6:2010 (Ed.3.1) and A1:2013 All applicable requirements have been met.
- The determination of substantial equivalence is also based on an assessment of the following testing:
- Environmental Testing encompassing:
- Mechanical Testing: Shock, vibration, and free fall to simulate the environment of use during stationary use and patient transport inside of hospitals, according to the IEC TR60721-4-7 Class 7M1 and IEC 60068-2-xx standard series.
- Temperature and humidity testing to simulate the climatic conditions during device operation in hospital environments and during storage.
- Human Factors Engineering Testing
The modified Graphical User Interface elements were evaluated and improved iteratively during the design phase conducting several formative usability evaluations, as per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" issued on February 3, 2016. These included established usability engineering methods such as focus groups, expert reviews and usability tests using user interface prototypes. User feedback was translated into iterative user interface improvements. All specified test requirements have been met and no new hazards have been identified. - WLAN Coexistence Testing
The specified pass/fail criteria has been met. - Software tests for:
- Safety risk assessment requirements.
- Software specifications requirements.
- Security risk requirements. All tests have been passed.
- Environmental Testing encompassing:
Conclusion:
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the specific predicates.
V&V testing comprised well-established software tests, safety and essential performance tests, and human factors engineering tests.
Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence with respect to safety and effectiveness.
The results demonstrate that the Philips IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 meet all defined reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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October 7, 2021
Philips Medizin Systeme Boeblingen GmbH Monica Silva Sr. Regulatory Affairs Engineer Hewlett-Packard-Strasse 2 Boeblingen, Baden-Wuerttemberg 71034 Germany
Re: K210906
Trade/Device Name: IntelliVue Patient Monitors MX750 and IntelliVue 4-Slot Module Rack FMX-4 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 Dated: September 3, 2021 Received: September 7, 2021
Dear Monica Silva:
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.
1
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 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 mediation-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.
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210906
Device Name
IntelliVue Patient Monitors MX750 and MX850 and IntelliVue 4-Slot Module Rack FMX-4.
Indications for Use (Describe)
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neontors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of thythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and petiativ within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
3
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/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 background is plain white, which makes the blue letters stand out.
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
-
- Submitter of this premarket notification
Monica da Silva Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: +49 151 4090 3561 e-mail: monica.dasilva(@philips.com
- Submitter of this premarket notification
This summary was prepared on March 23, 2021.
-
- The name and classification of the devices:
Trade name: IntelliVue Patient Monitors MX750 and IntelliVue 4-Slot Module Rack FMX-4.
- The name and classification of the devices:
Common name: Multiparameter Patient Monitor.
Classification:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | |||
| Devices | §870.1025, II | MHX | Monitor, Physiological, Patient (with |
| arrhythmia detection or alarms) | |||
| §870.1025, II | MLD | Monitor, ST Segment with Alarm | |
| §870.1100, II | DSJ | Alarm, Blood Pressure | |
| §870.1110, II | DSK | Computer, Blood Pressure | |
| §870.1130, II | DXN | System, Measurement, Blood-Pressure, | |
| Non-Invasive | |||
| §870.2300, II | DRT | Monitor, Cardiac (incl. Cardiotachometer & | |
| Rate Alarm) | |||
| §870.2340, II | DPS | Electrocardiograph | |
| §870.2700, II | DQA | Oximeter | |
| Device Panel | Classification | ProCode | Description |
| §870.2810, I | DSF | Recorder, Paper Chart | |
| §870.2300 II | MSX | System, Network and Communication, | |
| Physiological Monitors | |||
| Anesthesiology | |||
| Devices | §868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide, Gaseous- |
| Phase | |||
| §868.1500, II | CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase | |
| (Anesthetic Concentration) | |||
| §868.1500, II | NHO | Analyzer, Gas, Desflurane, Gaseous-Phase | |
| (Anesthetic Concentration) | |||
| §868.1500, II | NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase | |
| (Anesthetic Concentration) | |||
| §868.1500, II | NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase | |
| (Anesthetic Concentration) | |||
| §868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase | |
| (Anesthetic Concentration) | |||
| §868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide, Gaseous- | |
| Phase (Anesthetic Concentration) | |||
| §868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | |
| §868.1880, II | BZC | Data calculator Pulmonary-function | |
| §868.2375, II | BZQ | Monitor, Breathing Frequency | |
| §868.2480, II | LKD | Monitor, Carbon Dioxide, Cutaneous | |
| §868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for Infant not | |
| under Gas Anesthesia | |||
| §868.2775 II | KOI | Electrical peripheral nerve stimulator | |
| Neurological | |||
| Devices | §882.1400, II | GWQ | Electroencephalograph |
| §882.1420, I | GWS | Analyzer, Spectrum, Electroencephalograph | |
| Signal | |||
| General Hospital | |||
| and Personal Use | |||
| Devices | §880.2910, II | FLL | Thermometer, Electronic, Clinical |
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-
- Philips IntelliVue Patient Monitors MX750, MX850 are substantially equivalent to the previously cleared, primary predicate device, Philips IntelliVue Patient Monitor MX800 marketed pursuant to K161531.
Philips IntelliVue 4-Slot Module Rack FMX-4 is substantially equivalent to the previously cleared Philips IntelliVue 4-Slot Module Rack FMS-4 marketed pursuant to K110622.
- Philips IntelliVue Patient Monitors MX750, MX850 are substantially equivalent to the previously cleared, primary predicate device, Philips IntelliVue Patient Monitor MX800 marketed pursuant to K161531.
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Description of the device 4.
Hardware and software modifications carried out on the legally marketed device Intelli Vue Patient Monitor MX800 and its IntelliVue 4-Slot Module Rack FMS-4, resulted in new models, the IntelliVue Patient Monitors MX750, MX850 and their 4-Slot Module Rack FMX-4, the subject of this submission.
The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.
The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, EEG, BIS, NMT, and gas analysis.
The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.
The monitor models MX750 and MX850 differ mainly in size. Whilst MX750 has a 19" flat
panel display, MX850 has a 22" display.
Modifications:
Standard hardware components of the almost 10 years old predicate MX800, like flat panel display, touch screen, CPU, video board, and memory have been replaced in the MX750 and MX850 by state of the art electronic components. Two additional features, the NFC reader and adaptive lighting through the Ambient Light Sensor, have been implemented into the new MX750 and MX850 monitors.
The hardware of the new 4-Slot Module Rack FMX-4 is very similar to that of its 8 years old predicate 4-Slot Module Rack FMS-4. The new FMX-4 has the same housing, which is made of the same material as FMS-4 but has a slightly different shade of color (same shade of color as the new MX750 and MX850 monitors). The FMX-4 has a new Printed Circuit Assembly with standard hardware components like CPU and memory being replaced by state of the art electronic components.
The software modifications comprise the following changes:
- Support of the new state-of-the-art electronic components. -
- -Modified elements of the Graphical User Interface.
- -Implementation of a feature called Electronic Strip Recording. This feature allows electronic strips that can be reviewed on the monitor and printed out as a report on the printer.
- -Modification of the existing feature Remote Applications to support HTML5 and PDF format.
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Image /page/7/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.
None of the described modifications represents any change to the fundamental technology of the predicate device.
-
- Intended Use
The intended use and indications for use of the Philips Intelli Vue Patient Monitors MX750, MX850 and their IntelliVue 4-Slot Module Rack FMX-4, have not changed from the legally marketed predicate device IntelliVue Patient Monitor MX800 and the respective IntelliVue 4-Slot Module Rack FMS-4 as a result of the modifications.
- Intended Use
IntelliVue Patient Monitors MX750 and MX850 and IntelliVue 4-Slot Module Rack FMX-4.
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
8
Image /page/8/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.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
IntelliVue 4-Slot Module Rack FMX-4
The 4-Slot Module rack FMX-4 is intended to connect up to four particular plug-in physiological measurement modules to the dedicated host patient monitors.
Comparison of Technological Characteristics with Predicate Device 6.
| Comparative
Characteristics | Primary Predicate Device
Philips
IntelliVue Patient Monitors
MX800
(K161531) | Subject Devices
Philips
IntelliVue Patient Monitors
MX750 and MX850 |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hardware Aspects | | |
| Hardware Design | Monitors with display and CPU
integrated in one housing and
connectable to dedicated external
measurement modules. | Same |
| Material | Housing: PC ABS + PC
Front side: Glass with foil
On/Off Button: Silicone | Housing: PBT + PC
Front side: Chemically
strengthened Glass
On/Off Button: Same |
| Display | Size: 19"
Resolution:
WSXGA+ (1680 x 1050) | Size:
MX750: 19"
MX850: 22"
Resolution:
MX750: 1920 x 1080 (Full HD)
MX850: 1920 x 1080 (Full HD) |
| Touchscreen
Technology | Resistive touchscreen | Capacitive touchscreen |
| Hardware Visual
Alarm Indicators | Lamp indicators:
1 color coded alarm indicator lamp
(red, yellow, cyan)
1 color coded alarm indicator lamp
(red, yellow) | Same |
| | Primary Predicate Device | Subject Devices |
| Comparative
Characteristics | Philips
IntelliVue Patient Monitors
MX800
(K161531) | Philips
IntelliVue Patient Monitors
MX750 and MX850 |
| Alarm Loudspeaker | 1 color coded "alarms off" lamp
(red, yellow)
Loudspeaker technology: dynamic
loudspeaker | Same |
| Energy Type | Powered by AC mains | Same |
| Physiological Measurements | | |
| Internal
(built-in)
Physiological
Measurements | None | Same |
| Supported external
Measurement Modules | Multi-Measurement Modules directly connected to the patient monitor (including) Measurement Extensions attached to the Multi-Measurement Modules Measurement Modules directly connected to the patient monitor Measurement Modules connected to a host patient monitor via the dedicated Flexible Module Racks. | Same |
| Supported dedicated
Flexible Module
Racks | 8-Slot Module Rack FMS-8 (M8048A) 4-Slot Module Rack FMS-4 (865243) | 8-Slot Module Rack: not supported. Instead, supports two simultaneous 4-Slot Module Racks FMX-4 (866468). 4-Slot Module Rack FMS-4 (865243) not supported, substituted by FMX-4. |
| Connectivity features | | |
| Wireless Interfaces | WLAN 2.4 and 5 GHz, IEEE 802.11 a/b/g/n
Short Range Radio (SRR) 2.4 GHz,
ITS 2.4 GHz ISM, ITS 1.4 GHz WMTS Near Field Communication Interface (NFC): not supported | WLAN/Radio Module: Same
Short Range Radio (SRR): not supported
ITS 2.4 GHz ISM: not supported
ITS 1.4 GHz WMTS: not supported |
| Comparative
Characteristics | Primary Predicate Device
Philips
IntelliVue Patient Monitors
MX800
(K161531) | Subject Devices
Philips
IntelliVue Patient Monitors
MX750 and MX850 |
| | | Near Field Communication
Interface (NFC): Technology:
NFCIP-1, NFCIP-2 protocol,
ISO/IEC 14443A, ISO/IEC
14443B
Frequency: 13.56 MHz.
FCC ID : PQC-NFCBV1 |
| Wired Interfaces | LAN IEEE 802.3 100MBit
RS232/MIB ISO/IEEE 11073-30200
USB 2.0
ECG-Out
Basic Nurse Call Relay
Flexible Nurse Call Relay
Proprietary measurement Link (MSL)
Video Interface DVI analog & digital. | Same, except for not supported
Video Interface DVI analog &
digital. |
| Integrated PC | iPC (cleared with K101449)
Feature that allows for a computer
functionality within the monitor, so
that the user can use standard
applications as for i.e Web browser. | Same |
| Supported Remote
Display Application | Philips IntelliVue XDS solution | Same |
| Strip Recording | Paper-strip recorders M1116B and
M1116C | Same, additionally electronic-
strip recording in print database. |
| Remote Applications | Access to pre-configured applications
made available by hospital, hosted
remotely on the Philips Application
Server utilizing Citrix Presentation
Server™ and displayed and operated
on the MX800 patient monitor. | Same, but instead of Citrix
Presentation Server™, Citrix®
Xen App® and standard web
application servers are used. With
this modification the HTML5 and
PDF format are provided. |
| Human Interface (HIF) | | |
| Elements that
provide information
to the user | Indicator lights, display, visual and
audible alarms. | Same |
| Graphic user
interfaces of device | Selection of screen elements
Use touch screen to operate monitor
Moving windows
Use of SmartKeys | Same |
| Hardware
components that the
user handles to
control device
operation | Touchscreen: Yes
Remote control: Yes
USB Pointing devices: mouse,
trackball, keyboard, Barcode Reader | Same, except not supported
remote control. |
| Comparative
Characteristics | Primary Predicate Device
Philips
IntelliVue Patient Monitors
MX800
(K161531) | Subject Devices
Philips
IntelliVue Patient Monitors
MX750 and MX850 |
| Robustness | Mechanical Strength testing as per
IEC 60601-1: 1988 + A1: 1991 + A2:
1995. Additionally mechanical Class
7M1 | Same |
| Environmental
Specifications | - Operating Temperature Range: 0 to
40°C (32 to 100 °F) or 0 to 35°C
(32 to 95 °F) when equipped with
the iPC
- Storage Temperature Range: -20 to
60 °C (-4 to 140°F) - Operating Humidity Range: 15% to
95% RH, non-condensing - Storage Humidity Range: 5% to
95% RH - Operating Altitude Range: -500 to
3000 m (-1600 to 10000 ft) - Storage Altitude Range: -500 to
4600 m (-1600 to 15000 ft) - Ingress Protection: IPX1 | Same environmental
specifications.
Ingress Protection: IP21 |
| Biocompatibility | N/A, no patient contact | Same |
| EMC and Electrical
Safety | EMC: IEC 60601-1-2: 2014 (Ed.4)
Safety: IEC 60601-1 (3rd Ed.) +
Cor.1:2006 + Cor.2:2007 + A1:2012
and
ANSI AAMI ES60601-
1:2005/(R)2012 and A1:2012 | EMC: Same
Safety: Same |
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Image /page/9/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The background is plain white, which makes the word stand out.
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Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are large and evenly spaced.
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Image /page/11/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 background is white, providing a strong contrast that makes the word stand out.
7. Summary of V&V activities
The modified IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 with the current software Revision N.01 have been subject to the following V&V activities:
- -Testing according to the recognized consensus standard:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1)
- 트 IEC 60601-1-2:2014 (Ed. 4)
- I IEC 60601-2-23:2011 (Ed.3)
- I IEC 60601-2-25:2011 (Ed. 2)
- IEC 60601-2-27:2011(Ed. 3)
- l IEC 80601-2-30:2009 (Ed. 1.1) and A1:2013
- IEC 60601-2-34:2011(Ed.3)
- ' ISO 80601-2-55:2018 (Ed. 2)
- i ISO 80601-2-56:2017 (Ed. 2) and A1:2018
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Image /page/12/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 background is white, providing a strong contrast that makes the word stand out. The overall impression is clean and professional, reflecting the brand's image.
-
I ISO 80601-2-61:2017 (Ed. 2) and Corr1:2018
트 IEC 60601-1-8:2006 (Ed. 2.1) and A1:2012 All applicable requirements have been met. -
-Compliance with the recognized consensus process standards:
- IEC 62304:2006 (Ed. 1.1) and A1:2015 ■
- 트 IEC 60601-1-6:2010 (Ed.3.1) and A1:2013
All applicable requirements have been met.
- · The determination of substantial equivalence is also based on an assessment of the following testing:
- -Environmental Testing encompassing:
- I Mechanical Testing: Shock, vibration, and free fall to simulate the environment of use during stationary use and patient transport inside of hospitals, according to the IEC TR60721-4-7 Class 7M1 and IEC 60068-2-xx standard series.
- I Temperature and humidity testing to simulate the climatic conditions during device operation in hospital environments and during storage.
- -Human Factors Engineering Testing
The modified Graphical User Interface elements were evaluated and improved iteratively during the design phase conducting several formative usability evaluations, as per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" issued on February 3, 2016. These included established usability engineering methods such as focus groups, expert reviews and usability tests using user interface prototypes. User feedback was translated into iterative user interface improvements. All specified test requirements have been met and no new hazards have been identified.
-
-WLAN Coexistence Testing
The specified pass/fail criteria has been met. -
Software tests for: -
- Safety risk assessment requirements. 트
- I Software specifications requirements.
- 트 Security risk requirements.
All tests have been passed.
-
- Conclusion
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the specific predicates.
- Conclusion
V&V testing comprised well-established software tests, safety and essential performance tests, and human factors engineering tests.
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Image /page/13/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 the only element in the image and it is centered.
Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence with respect to safety and effectiveness.
The results demonstrate that the Philips IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 meet all defined reliability requirements and performance claims.