IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. November 22, 2023 Philips Medizin Systeme Boeblingen GmbH Monica Da Silva Principal Regulatory Affairs Specialist Hewlett-Packard-Strasse 2 Boeblingen, BW 71034 Germany Re: K230604 Trade/Device Name: Intelli Vue Patient Monitor MX100 (867033), Intelli Vue Multi-Measurement Module X3 (867030) 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, DOA, DRT, DSI, DSJ, DXN, FLL, MLD Dated: October 27, 2023 Received: October 27, 2023 Dear Monica Da 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Jennifer W. Shih -S Jennifer Shih Kozen 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K230604 Device Name IntelliVue Patient Monitor MX100 (867033) IntelliVue Multi-Measurement Module X3 (867030) Indications for Use (Describe) Intended Use: The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Indication for Use: The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is only for use on one patient at a time. The monitor is not a therapeutic device. Caution: The monitor is 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. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. Warning: 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 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 monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside the hospital environment. It is not intended for home use. Warning: The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers). Contraindications: There are no known contraindications for the IntelliVue MX100/X3 Patient Monitor/Multi-Measurement Module. 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) CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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." {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 word is centered and takes up most of the frame. The background is white. ## 510(k) Summary | 510(k) Summary | | | | | | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------|---------|-------------|-----------------|--| | 1.1 Submitter | | | | | | | Date Prepared | March 3, 2023 | | | | | | Submitter/Owner | Philips Medizin Systeme Böblingen GmbH<br>FDA Establishment Number 9610816<br>Hewlett-Packard-Str. 2<br>71034 Böblingen<br>Germany | | | | | | Key Contact | Monica da Silva<br>Principal Regulatory Affairs Specialist<br>moncia.dasilva@philips.com<br>Phone: +49 151 40903561 | | | | | | 510(k) Submission No. | K230604 | | | | | | 1.2 Device | | | | | | | Trade Name | IntelliVue Multi-Measurement Module X3<br>IntelliVue Patient Monitor MX100 | | | | | | 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 | | | | | | | Predicate Device | 510(k) No. | Company | Device Name | Product<br>Code | | The subject devices are substantially equivalent to the legally marketed predicate devices. #### 1.4 Device Description IntelliVue Patient Monitors X3 and MX100 – description of the device per 21 CFR 807.92(a) (4) The Multi-Measurement Module X3 and the IntelliVue Patient Monitor MX100, acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The devices IntelliVue Patient Monitor MX100 Image /page/5/Picture/9 description: The image shows the Philips logo, which is a shield-shaped emblem in blue and white. The word "PHILIPS" is written in blue at the top of the shield. Inside the shield, there are two wavy lines that resemble water or sound waves, and two four-pointed stars are positioned above and below the waves. The overall design is simple and recognizable, representing the brand's identity. MHX {6}------------------------------------------------ offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The X3 and MX100 can interact with the Central Station via LAN or wireless link. The Multi-Measurement Module X3 and IntelliVue Patient Monitor MX100 are compact, rugged, lightweight monitors with built-in invasive and non-invasive measurements, namely ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2. It can further extend the measurement capabilities when connecting to the legally marketed IntelliVue Multi-Measurement Extensions The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor. #### 1.5 Intended Use and Indication for Use ### Intended Use as required per 21 CFR 807.92(a)(5) #### Intended Use: The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. ### Indications for Use: The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is only for use on one patient at a time. The monitor is not a therapeutic device. Caution: The monitor is 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. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. Warning: 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 adults patients. Image /page/6/Picture/18 description: The image shows the Philips logo, which is a shield-shaped emblem in blue. Inside the shield, there are two wavy lines representing sound waves, with a four-pointed star above and below the waves. The word "PHILIPS" is written in white at the top of the shield. {7}------------------------------------------------ Image /page/7/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 word is centered and takes up most of the frame. The background is plain white. 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 conditions, and for patients who are well or poorly perfused. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside the hospital environment. It is not intended for home use. Warning: The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers). Contraindications: There are no known contraindications for the IntelliVue MX100/X3 Patient Monitor/Multi-Measurement Module. #### Comparison of Intended Uses for Subject Device and Predicate 1.6 The modified Multi-Measurement Module X3 and IntelliVue Patient Monitor MX100 have the same intended use and indications as the legally marketed predicate device. #### 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 architecture monitor hardware entirely unchanged | | Materials | same materials used as those of the predicate devices biocompatibility aspects do not apply because the devices do not have patient contact biocompatibility aspects of accessories are not affected, because all accessories of the predicate devices remain unchanged | | Energy Source | Powered by dedicated external power supply or from connected host patient monitor (via MSL interface, X3 only) or from built-in battery devices do not deliver energy to the patients for their function, same as predicate devices | | Software/Hardware<br>Features | proposed modification does not introduce any new technological hardware features is unchanged from its predicate device measurements of physiological parameters are the same as in the predicate devices | Image /page/7/Picture/11 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. Above the shield, the word "PHILIPS" is written in a sans-serif font, also in blue. {8}------------------------------------------------ Image /page/8/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 word is centered and takes up most of the frame. The background is plain white. | Physiological<br>Parameters | existing physiological parameters of the predicate devices remain<br>unchanged is the same as those of its respective predicate device | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance<br>specifications | specifications of all measurement characteristics, including measurement<br>principles, methods, algorithms, and all detailed performance<br>specifications remain unchanged | | Operating Principle<br>and Mechanism of<br>Action | unchanged from the predicate devices | | Human Interface | human interface of the IntelliVue X3 and MX100 remain the same | | Measurement<br>Accessories | all accessories of the predicate devices IntelliVue Patient Monitor X3 IntelliVue Patient Monitor MX100 are re-used without any change | | Differences | | | Software | A new software version designated as IntelliVue Software P.01 introduced<br>the following new features: New alarm sounds designated as “Philips 2021” sounds. Configurable alarm management, limiting changes in alarm settings to<br>pre-defined authorized personnel. Additionally, the new Software revision will further enhance the following<br>existing features: Early Warning Score Validation followed by user identification via<br>Single Sign On Additional SPO2 fallback configuration Additional Lead Diagram presentation for ECG Enhancement of presentation of the global "alarm off" state | Image /page/8/Picture/4 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 blue at the top of the shield. {9}------------------------------------------------ Image /page/9/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 word is centered and takes up most of the frame. #### 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 (K182979). 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 # | |------------------------------------------------------------------------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI AAMI ES60601-<br>1:2005/(R)2012 and<br>A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 | 19-4 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance | | IEC 60601-1-2 Edition<br>4.0 | 19-8 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance<br>- Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests | | IEC 60601-1-6 Edition<br>3.2 | 5-132 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance<br>- Collateral standard: Usability | | IEC 60601-1-8 Edition<br>2.2 (CSV) | 5-131 | Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and essential performance<br>- Collateral Standard: General requirements tests and<br>guidance for alarm systems in medical electrical<br>equipment and medical electrical systems | | IEC 62304 Edition 1.1 (CSV) | 13-79 | Medical device software - Software life cycle processes | Image /page/9/Picture/9 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. {10}------------------------------------------------ Image /page/10/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 word is centered and takes up most of the frame. The background is plain white. ### Non-clinical Bench Tests No new issues of safety or effectiveness as compared to the predicate are introduced because of using this device. ### Clinical Studies The subject devices, like the primary predicate devices, did not require clinical trials. Compliance to the FDA Quality System Regulations, 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. No new issues of substantial equivalence are 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, usability and interoperability testing, 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/10/Picture/12 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two stars. The word "PHILIPS" is written in white at the top of the shield.