IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)

K221348 · Philips Medizin Systeme Böblingen GmbH · MHX · Feb 3, 2023 · Cardiovascular

Device Facts

Record IDK221348
Device NameIntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
ApplicantPhilips Medizin Systeme Böblingen GmbH
Product CodeMHX · Cardiovascular
Decision DateFeb 3, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1025
Device ClassClass 2
AttributesPediatric

Intended 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 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. The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments. The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

Device Story

IntelliVue MX750/MX850 are bedside multiparameter patient monitors; acquire physiological signals (ECG, SpO2, EEG, CO2, etc.) via plug-in modules; display waveforms, trends, and alarm data. New plug-in modules (867184, 867185, 867186) provide isolated digital communication interfaces to integrate external Masimo O3, IRMA/ISA CO2, and SedLine measurement devices. Monitors serve as host for data presentation and user control. Clinicians use output for real-time patient assessment and clinical decision-making; aids in monitoring anesthetic effects and physiological status. Benefits include centralized monitoring of diverse parameters in surgical, cardiac, and ICU settings.

Clinical Evidence

Bench testing only. No new clinical trials required as integrated measurement technologies are unchanged from their respective predicate devices. Compliance demonstrated via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm system standards (IEC 60601-1-8), and software validation (IEC 62304).

Technological Characteristics

Multiparameter monitor with 19"/22" touchscreen. Connectivity via plug-in modules providing electrical isolation for power/data. Software-based signal processing. Standards: IEC 62304 (software), ANSI AAMI ES60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), ISO 80601-2-55 (gas monitors).

Indications for Use

Indicated for monitoring physiological parameters in adults, pediatrics, and neonates by healthcare professionals in hospital environments. Specific parameters (ST segment, PPV, Sepsis Protocol, SedLine) restricted to adult populations; IPI restricted to 1-12 years. Not for home use or transport.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. February 3, 2023 Philips Medizin Systeme Böblingen GmbH Stefan Breuer Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 Böblingen, BW 71034 Germany Re: K221348 Trade/Device Name: IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470) 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: May 12, 2022 Received: January 4, 2023 Dear Stefan Breuer: 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Shruti N. Mistry -S for 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) K221348 ### Device Name IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470) ### 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 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 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 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 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. The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments. The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentani, Desflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 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 evenly spaced and the overall appearance is clean and modern. # 510(k) Summary | 510(k) Summary | | | | | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------------------------|--------------| | 1.1 Submitter | | | | | | Date Prepared | April 27, 2022 | | | | | Submitter/Owner | Philips Medizin Systeme Böblingen GmbH<br>FDA Establishment Number 9610816<br>Hewlett-Packard-Str. 2<br>71034 Böblingen<br>Germany<br>Phone: +49 151 1961 5514<br>Fax: +49 7031 463 2442 | | | | | Key Contact | Stefan Breuer<br>Senior Regulatory Affairs Engineer<br>Stefan.Breuer@philips.com | | | | | 510(k) Submission Type | This is a traditional 510(k). | | | | | 1.2 Device | | | | | | Trade Name | IntelliVue Patient Monitor MX750<br>IntelliVue Patient Monitor MX850 | | | | | Common Name | Multiparameter Patient Monitor | | | | | Classification Name | Panel & Name: Cardiovascular Devices<br>Subpart & Division: 21 CFR §870.1025<br>Regulatory Class: II<br>Product Code: MHX | | | | | 1.3 Predicate Device | | | | | | | 510(k) No. | Company | Device Name | Product Code | | Primary Predicate Device | K210906 | Philips | IntelliVue Patient Monitor MX750<br>IntelliVue Patient Monitor MX850 | MHX | | Reference Devices | K162603 | Masimo | O3 Regional Oximeter System | MUD | | | K123043 | Masimo | Infrared Mainstream (IRMA) CO2 Gas Analyzer | CCK | | | K171121 | Masimo | Infrared Sidestream (ISA) CO2 Gas Analyzer | CCK | | | K172890 | Masimo | SedLine Sedation Monitor | OLW | Image /page/4/Picture/5 description: The image shows the Philips logo. The logo is a blue shield with the word "PHILIPS" in white at the top. Below the word, there are two wavy lines and two stars. The stars are four-pointed and have a plus sign in the center. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. The subject devices are substantially equivalent to the legally marketed predicate devices. ### 1.4 Device Description ## IntelliVue Patient Monitors MX750 and MX850 – description of the device per 21 CFR 807.92(a) (4) 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 measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, 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. While MX750 has a 19" flat panel display, MX850 has a 22″ display. ### 1.5 Indication for Use ## Intended Use as required per 21 CFR 807.92(a)(5) 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. Image /page/5/Picture/17 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there is a white circle with two wavy lines across the middle. There are also two four-pointed stars, one on the upper left and one on the lower right of the circle. Above the shield, the word "PHILIPS" is written in blue. {6}------------------------------------------------ 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 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. The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments. The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. ### 1.6 Comparison of Intended Uses for Subject Device and Predicate The modified IntelliVue MX750 and MX850 have the same intended use and indications as the predicate devices, with the addition of the following paragraphs, which have been adopted without change from the predicate devices Masimo O3 Regional Oximeter System and Masimo SedLine Sedation Monitor: Image /page/6/Picture/13 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble sound waves or water waves. Above and below the waves are two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield. {7}------------------------------------------------ - · The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments. - The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentany), Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. Adding compatibility to Masimo IRMA CO2 and ISA CO2 does not affect the intended use or indications for use of the IntelliVue MX750 and MX850. The predicate devices IntelliVue MX750 and MX850 have already been able to measure Mainstream CO2 and Sidestream CO2 using measurement modules of the same technologies as the subject devices. Therefore, adding compatibility to Masimo IRMA CO2 and ISA CO2 merely gives the customer a broader choice of CO2 measurements, but does not add indications for use or intended uses to the IntelliVue MX750 and MX850. | 1.7 Comparison of Technological Characteristics with Predicate Device | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Similarities | | | | Item of<br>Comparison | Description/Rationale | | | Device Design | device design of subject devices is the same as for the predicate devices unchanged hardware and software architecture monitor hardware entirely unchanged device design of added external measurements Masimo O3 Regional Oximeter System Masimo IRMA CO2 and ISA CO2 Masimo SedLine is identical to their predicate devices | | | Materials | • same materials used as those of the predicate devices | | | | • materials used in the new plug-in modules<br>– O3 (867184)<br>– CO2 (867185)<br>– SedLine (867186)<br>are the same as those of other legally marketed plug-in modules | | | | • biocompatibility aspects do not apply because the devices do not have<br>patient contact. | | | | • materials used in the added external measurements<br>– Masimo O3 Regional Oximeter System<br>– Masimo IRMA CO2 and ISA CO2<br>– Masimo SedLine<br>are identical to their predicate devices. | | | | • biocompatibility aspects of accessories are not affected, because all<br>accessories of the predicate devices remain unchanged | | | | Energy Source | | | | | Software/Hardware<br>Features | | | | | | • hardware and software of the added external measurements<br>– Masimo O3 Regional Oximeter System<br>– Masimo IRMA CO2 and ISA CO2<br>– Masimo SedLine<br>is unchanged from their predicate devices | | | | • measurements of physiological parameters are exactly the same as in the<br>predicate devices | | | | Physiological<br>Parameters | existing physiological parameters of the predicate devices remain unchanged the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine are the same as those of their respective predicate devices | | | Performance<br>specifications | specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications remain unchanged performance specifications of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine remain unchanged | | | Operating Principle<br>and Mechanism of<br>Action | unchanged from the predicate devices | | | Human Interface | human interface of the IntelliVue MX750 and MX850 remains exactly the same the newly added external measurements Masimo O3 Masimo SedLine do not have a human interface of their own; the Masimo IRMA CO2 Masimo ISA CO2 only have a status LED. Data presentation and user control are done through the connected host monitor, same as for their predicate devices | | | Measurement<br>Accessories | all accessories of the predicate devices IntelliVue Patient Monitor MX750 IntelliVue Patient Monitor MX850 as well as those of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine are re-used without any change | | | Differences | | | | Hardware | three new plug-in modules O3 (product number 867184) CO2 (product number 867185) SedLine (product number 867186) are created, which act as a digital communication interface between the IntelliVue Patient Monitors MX750/MX850, and the external Masimo measurement devices the CO2 plug-in module interfaces both CO2 gas analyzers: IRMA CO2 and ISA CO2 the new plug-in modules do not alter or modify the contents of the transferred data the new plug-in modules also provide electrical isolation for both power and communication between patient monitor and the external O3, IRMA CO2, ISA CO2 and SedLine measurement devices; the patient isolation circuit is the same as for other legally marketed plug-in modules for the IntelliVue patient monitor family the predicate external measurement devices Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine also connect to a host monitor / backboard device using an isolated digital interface, where the isolation has to be provided by that host monitor / backboard device; the new plug-in modules 867184, 867185 and 867186 provide exactly this isolated digital interface as optional plug-in modules, specialized for the IntelliVue Patient Monitors MX750 and MX850 | | | Software | The software of the subject devices IntelliVue MX750 and MX850 has been extended so that the new plug-in modules will be accepted as compatible and the physiological data provided by the Masimo O3, IRMA CO2, ISA CO2 and SedLine measurement devices will be displayed on the patient monitor screen. | | | Physiological<br>Parameters | For marketing reasons, the proposed modification does not provide the parameters and graphical presentations Delta SpO2 / ΔSpO2 (O3) DSA (SedLine) which the predicate devices are providing. | | ## f Technological Characteristics with Predicate Device Image /page/7/Picture/8 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a custom typeface associated with the Philips brand. Image /page/8/Picture/4 description: The image contains the Philips logo. The logo is a blue shield shape with the word "PHILIPS" written in white at the top. Inside the shield, there are two wavy lines and three stars. The logo is simple and recognizable. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a custom typeface associated with the Philips brand. Image /page/9/Picture/4 description: The image features the Philips logo, which is a distinctive emblem associated with the global technology company. The logo is primarily blue and consists of the word "PHILIPS" in a sans-serif font positioned above a circular design. The circular design contains stylized waves and stars, creating a recognizable and iconic symbol for the brand. {10}------------------------------------------------ Image /page/10/Picture/0 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 white, which makes the blue text stand out. ד Image /page/10/Picture/4 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble water. Above and below the wavy lines, there are four-pointed stars. The word "PHILIPS" is written in white at the top of the shield. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. ### Substantial Equivalence Summary Operational and technological characteristics form the basis for the determination of substantial equivalence of the subject devices with the legally marketed predicate devices. The subject devices are substantially equivalent to the predicate devices. ### 1.8 Performance Data ## Non-Clinical Tests – Harmonized Standards The subject devices have passed all safety tests for demonstrated compliance with the recognized standards below. | Standard | FDA<br>Recognition # | Title # | |----------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 62304 Edition 1.1<br>2015-06 consolidated<br>version | 13-79 | Medical device software - Software life cycle processes | | ANSI AAMI ES60601-<br>1:2005/(R)2021 and<br>A1:2012 | 19-4 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance | | IEC 60601-1-2 Edition<br>4.0 2014-02 | 19-8 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests | | IEC60601-1-8 Edition<br>2.1 2012-11 | 5-76 | Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: General<br>requirements tests and guidance for alarm systems in<br>medical electrical equipment and medical electrical<br>systems | | ISO 80601-2-55 Second<br>edition 2018-02 | 1-140 | Medical electrical equipment - Part 2-55: Particular<br>requirements for the basic safety and essential<br>performance of respiratory gas monitors | Image /page/11/Picture/9 description: The image features the Philips logo, which is a blue shield-like shape. Inside the shield, there are two wavy lines that resemble sound waves or water. Above and below the waves are four-pointed star shapes. The word "PHILIPS" is written in a sans-serif font at the top of the shield, also in blue. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is a bright, saturated blue. The letters are evenly spaced and appear to be a logo or brand name. ## Non-clinical Bench Tests There were no new questions of safety or effectiveness introduced as a result of using this device. ### Clinical Studies The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo O3, IRMA CO2, ISA CO2 and SedLine parameters are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor. FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the subject devices. Based upon the design, intended use, indications for use, classification, usability and safety testing, the subject devices are substantially equivalent to the listed predicate devices. There were no new questions of safety or effectiveness introduced as a result of using this device. ### 1.9 CONCLUSIONS The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, human factors and usability demonstrate that the modified devices do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the predicate devices. Image /page/12/Picture/12 description: The image shows the Philips logo, which is a shield-shaped emblem in blue and white. The word "PHILIPS" is written in white at the top of the shield. Inside the shield, there are two wavy lines and four stars. The wavy lines are positioned horizontally across the center of the shield, and the stars are placed above and below the wavy lines.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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