IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550

K192137 · Philips Medizin Systeme Boeblingen GmbH · MHX · Sep 11, 2020 · Cardiovascular

Device Facts

• Record ID: K192137
• Device Name: IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 11, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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 additionally intended for use in transport situations within hospital environments. The monitors are only for use on one patient at a time. 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only. 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 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.

Device Story

IntelliVue MX500/MX550 are multiparameter patient monitors for hospital use; acquire physiological signals (ECG, SpO2, CO2, EEG, etc.) via plug-in modules and sensors; display real-time waveforms, trends, and measurement values; generate physiological/technical alarms. Operated by trained healthcare professionals at bedside or during transport. Data processed to support clinical decision-making; integrated with hospital networks via LAN/wireless. New modifications include integration of Masimo O3 Regional Oximeter and Masimo IRMA/ISA CO2 analyzers. Output allows clinicians to monitor patient status, guide anesthetic administration (BIS), and track sepsis protocols (ProtocolWatch). Benefits include continuous, multi-modal patient surveillance to facilitate timely clinical intervention.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, software verification/validation, and adherence to recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 62304).

Technological Characteristics

Multiparameter monitor with touchscreen interface, video output, and LAN/wireless connectivity. Supports plug-in modules for invasive/non-invasive measurements. Software-based processing. Complies with ANSI/AAMI ES60601-1 (safety) and IEC 60601-1-2 (EMC). Not sterile; no patient contact for monitor hardware.

Indications for Use

Indicated for monitoring physiological parameters in adults, pediatrics, and neonates by healthcare professionals in hospital environments, including transport. Specific measurements (ST segment, PPV, Sepsis Protocol) restricted to adults; tcGas restricted to neonates; IPI restricted to adults and pediatrics (1-12 years); O3 Regional Oximeter restricted to patients ≥5 kg.

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

• IntelliVue Patient Monitors MX500 and MX550 (K161531)

Reference Devices

• Masimo O3 Regional Oximeter System (K162603)
• Masimo Infrared Mainstream Gas Analyzer CO2 (K123043)
• Masimo Infrared Sidestream Gas Analyzer CO2 (K171121)

Submission Summary (Full Text)

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September 11, 2020

Philips Medizin Systeme Boeblingen GmbH Stefan Breuer Senior Regulatory Affairs Engineer Hewlett-Packard-Str. 2 Boeblingen, 71034, Germany

Re: K192137

Trade/Device Name: IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 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, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRO, DRT, DPS, MLC, DRW, KRC, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, MSX, DRG, MUD, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOL, GWR, GWS, FLL Dated: August 12, 2020 Received: August 13, 2020

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.

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Expiration Date: 06/30/2020 See PRA Statement below.

Form Approved: OMB No. 0910-0120

510(k) Number (if known) K192137

### Device Name

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550

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 neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. 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 EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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.

(continued on next page)

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED

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| FORM FDA 3881 (7/17) | Page 1 of 2 | PSC Publishing Services [phone] EF |
|----------------------|-------------|-------------------------------------------|
|----------------------|-------------|-------------------------------------------|

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## Indications for Use (continued)

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 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.

| FORM FDA 3881 (7/17) | Page 2 of 2 | PSC Publishing Services [phone] |
|----------------------|-------------|----------------------------------------|
|----------------------|-------------|----------------------------------------|

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#### 510(k) Summary 5

| 510(k) Summary | | | | | |
|---------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------------------------------------------------------------------|-------------|
| SUBMITTER | | | | | |
| 5.1 | Date Prepared | August 12, 2020 | | | |
| 5.2 | Submitter/Owner | Philips Medizin Systeme Boeblingen GmbH<br>FDA Establishment Registration Number 9610816<br>Hewlett-Packard-Str. 2<br>71034 Boeblingen<br>Germany<br>Phone: [phone]<br>Fax: [phone] | | | |
| 5.3 | Key Contact | Stefan Breuer<br>Senior Regulatory Affairs Engineer<br>[e-mail] | | | |
| 5.4 | 510(k) Submission Type | Abbreviated 510(k) | | | |
| DEVICE | | | | | |
| 5.5 | Trade Name | IntelliVue Patient Monitors MX500 and MX550 | | | |
| 5.6 | Common Name | Multiparameter Patient Monitor | | | |
| 5.7 | Classification<br>Name | Device Panel | Classification | ProCode | Description |
| Cardiovascular<br>Devices | | §870.1025, II | MHX | Monitor, Physiological, Patient<br>(with arrhythmia detection or<br>alarms) | |
| | | §870.1025, II | DSI | Detector and alarm, arrhythmia | |
| | | §870.1025, II | MLD | Monitor, ST Segment with<br>Alarm | |
| | | §870.1100, II | DSJ | Alarm, Blood Pressure | |
| | | §870.1110, II | DSK | Computer, Blood Pressure | |
| | | §870.1130, II | DXN | System, Measurement, Blood-<br>Pressure, Non-Invasive | |
| | | §870.1435, II | DXG | Computer, Diagnostic, Pre-<br>Programmed, Single-Function | |
| | | §870.1915, II | KRB | Probe, Thermodilution | |
| | | §870.2060, II | DRQ | Amplifier and Signal<br>Conditioner, Transducer Signal | |
| | | §870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate | |

Philips Monitoring & Analytics

8870.2340, II

8870.2340, II

PHILIPS

[phone]

[e-mail]

DPS

MLC

Electrocardiograph

Monitor, ST Segment

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## IntelliVue Patient Monitors MX500 and MX550

| §870.2350, II | DRW | Electrocardiograph, Lead<br>Switching Adapter | |
|---------------------------|---------------|------------------------------------------------------------------------|------------------------------------------------------------------------------|
| §870.2370, II | KRC | Tester, Electrode, Surface,<br>Electrocardiograph | |
| §870.2600, I | DRJ | System, Signal Isolation | |
| §870.2700, II | DQA | Oximeter | |
| §870.2770, II | DSB | Plethysmograph, Impedance | |
| §870.2800, II | DSH | Recorder, Magnetic tape,<br>Medical | |
| §870.2810, I | DSF | Recorder, Paper Chart | |
| §870.2850, II | DRS | Extravascular Blood Pressure<br>Transducer | |
| §870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector | |
| - | MSX | System, Network and<br>Communication, Physiological<br>Monitors | |
| §870.2910, II | DRG | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency | |
| §870.2700, II | MUD | Oximeter, Tissue Saturation | |
| Anesthesiology<br>Devices | §868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,<br>Gaseous-Phase |
| | §868.1500, II | CBQ | Analyzer, Gas, Enflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | §868.1500, II | NHO | Analyzer, Gas, Desflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | §868.1500, II | NHP | Analyzer, Gas, Sevoflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | §868.1500, II | NHQ | Analyzer, Gas, Isoflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | §868.1620, II | CBS | Analyzer, Gas, Halothane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | §868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | §868.1720, II | CCL | Analyzer, Gas, Oxygen,<br>Gaseous-Phase |
| | §868.1880, II | BZC | Data calculator Pulmonary-<br>function |
| | §868.2375, II | BZQ | Monitor, Breathing Frequency |
| | §868.2480, II | LKD | Monitor, Carbon Dioxide,<br>Cutaneous |
| | §868.2500, II | KLK | Monitor, Oxygen, Cutaneous,<br>for Infant not under Gas<br>Anesthesia |
| | §868.2775 II | KOI | Electrical peripheral nerve<br>stimulator |

Image /page/5/Picture/5 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 and four stars. The wavy lines are positioned horizontally in the center, and the stars are placed above and below the lines.

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### IntelliVue Patient Monitors MX500 and MX550

| Neurological<br>Devices | §882.1400, II | GWR | Electroencephalograph |
|----------------------------------------------------|---------------|-----|-----------------------------------------------------|
| | §882.1420, I | GWS | Analyzer, Spectrum,<br>Electroencephalograph Signal |
| General<br>Hospital and<br>Personal Use<br>Devices | §880.2910, II | FLL | Thermometer, Electronic,<br>Clinical |

### PREDICATE DEVICE

| 5.8 Predicate Devices | | 510(k) No. | Company Name Device Name | Product Code |
|-----------------------|-------------------|------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Primary Predicate | K161531 | Philips<br>IntelliVue Patient Monitors MX500 and MX550 | See Section<br>5.7 |
| Reference Devices | Reference Device | K162603 | Masimo O3 Regional Oximeter System | MUD |
| | Reference Device | K123043 | Masimo Infrared Mainstream Gas Analyzer CO2 | CCK, CBQ,<br>CBR, CBS,<br>NHO, NHP,<br>NHQ |
| | Reference Device | K171121 | Masimo Infrared Sidestream Gas Analyzer CO2 | MWI, BZQ,<br>CAT, CBQ,<br>CBR, CBS,<br>CCK, CCL,<br>DPZ, DQA,<br>DXN, FLL,<br>GWQ, GXY,<br>NHO, NHP,<br>NHQ, OLT,<br>OLW, OMC,<br>ORT |

The Philips IntelliVue Patient Monitor MX500 is substantially equivalent to the legally marketed Philips IntelliVue Patient Monitor MX500 (K161531).

The Philips IntelliVue Patient Monitor MX559 is substantially equivalent to the legally marketed Philips IntelliVue Patient Monitor MX550 (K161531).

#### DEVICE DESCRIPTION

#### 5.9 Philips IntelliVue Patient Monitors MX500 and MX550 - description of the device per 21 CFR 807.92(a)(4)

The IntelliVue Patient Monitors MX500 and MX550 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 monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis.

Image /page/6/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. The word "PHILIPS" is written in blue at the top of the shield.

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The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located at the patient bedside vicinity and can also be used during patient transport inside hospitals.

The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

INDICATIONS FOR USE

5.10 Intended Use as required per 21 CFR 807.92(a)(5)

Image /page/7/Picture/8 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a sans-serif font, positioned above a circular emblem. The emblem features two wavy lines and four stars, all rendered in a blue color. The logo is simple and recognizable, representing the brand's identity.

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# PH

T

Image /page/8/Picture/4 description: The image features the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines at the top and four stars at the bottom. The word "PHILIPS" is written in white at the top of the shield.

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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 standard typeface.

| Philips<br>IntelliVue<br>Patient<br>Monitors<br>MX500 and<br>MX550 | The monitors are indicated for use by health care professionals whenever there is a need<br>for monitoring the physiological parameters of patients. |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The monitors are intended to be used for monitoring and recording of, and to generate<br>alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The<br>monitors are intended for use by trained healthcare professionals in a hospital<br>environment. |
| | The monitors are additionally intended for use in transport situations within hospital<br>environments. |
| | The monitors are only for use on one patient at a time. They are not intended for home<br>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<br>detailed morphology of complex cardiac complexes (according to AAMI EC 11). |
| | ST segment monitoring is intended for use with adult patients only and is not clinically<br>validated for use with neonatal and pediatric patients. |
| | The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is<br>restricted to neonatal patients only. |
| | BIS is intended for use under the direct supervision of a licensed health care practitioner<br>or by personnel trained in its proper use. It is intended for use on adult and pediatric<br>patients within a hospital or medical facility providing patient care to monitor the state of<br>the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring<br>the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic<br>administration may be associated with the reduction of the incidence of awareness with<br>recall in adults during general anesthesia and sedation. |
| Primary<br>Predicate | The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended<br>for use with adult patients only. |
| | The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12<br>years) patients only. The IPI is an adjunct to and not intended to replace vital sign<br>monitoring. |
| | The derived measurement Pulse Pressure Variation (PPV) is intended for use with<br>sedated patients receiving controlled mechanical ventilation and mainly free from cardiac<br>arrhythmia. The PPV measurement has been validated only for adult patients. |
| | The IntelliVue NMT Module is intended to be used as an objective neuromuscular<br>transmission monitor, using accelerometry for measuring the muscle contraction following<br>an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used<br>with adult and pediatric patients. |
| | The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of<br>functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate,<br>carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total<br>hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow<br>SET measurement is indicated for use during both no motion and motion conditions, and<br>for patients who are well or poorly perfused. |

Philips Monitoring & Analytics [e-mail] [e-mail]

Image /page/9/Picture/5 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 blue.

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Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is blue. The background is white, providing a clear contrast for the text to stand out.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE DEVICE

## 5.11 Predicate Device Comparison Table

| Similarities | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Feature of Comparison | Description of Feature |
| Indications for use | Indicated for use by health care professionals whenever there is a need<br>for monitoring the physiological parameters of patients. |
| Users | Healthcare professionals |
| Target patient population | Adult, pediatric, neonatal |
| Environment of use | In hospital environments |
| Monitor mechanical and<br>electrical/electronic<br>hardware, including<br>dimensions and weight | The proposed changes do not cause any changes to the monitors'<br>electrical or mechanical hardware. |
| Human, device and system<br>interfaces | The human, device and system interfaces of the monitors are not altered<br>by the proposed changes. |
| Electrical safety | ANSI/AAMI ES60601-1:2005/(R)2012, Ed.3 (cons.),<br>IEC 60601-1, Ed.3.1:2012-08 (cons.) |
| Temperature/humidity<br>specifications | Temperature and humidity specifications are not affected by the<br>proposed changes. |
| Biocompatibility | The devices do not have patient contact, therefore biocompatibility<br>aspects are not applicable. |

| Differences | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature of Comparison | Description of Feature |
| Intended use | The intended use has been extended by the intended use of the added<br>Masimo O3 Regional Oximeter System:<br><br>The noninvasive Masimo O3 Regional Oximeter System and<br>accessories are intended for use as an adjunct monitor of absolute and<br>trended regional hemoglobin oxygen saturation of blood (rSO2) in the<br>cerebral region under the sensors. The Masimo O3 Regional Oximeter<br>System and accessories are indicated for use on adults ≥40 kg and on<br>pediatrics ≥5 kg and <40 kg in healthcare environments.<br><br>This added statement is unchanged from the reference device and does<br>not alter the substantial equivalence of the devices. |
| Supported physiological<br>measurements, including<br>all specifications and<br>accessories | Masimo O3, IRMA CO2 and ISA CO2 have been added to the otherwise<br>unchanged physiological measurements that the devices support.<br>The added measurements do not alter the substantial equivalence of the<br>devices. |
| Electromagnetic<br>compatibility | Subject devices conform to IEC 60601-1-2:2014 (Ed. 4); predicate<br>devices have conformed to IEC 60601-1-2:2007 (Ed. 3).<br>This change is due to updated recognized consensus standards and<br>does not alter the substantial equivalence of the devices. |
| Plug-in modules | Two plug-in modules are added: |

Philips Monitoring & Analytics [e-mail] [e-mail]

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| Differences | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature of Comparison | Description of Feature |
| | O3 plug-in module (867184) digital interface and isolating power<br>supply to external Masimo O3 measurement device CO2 plug-in module (867185) digital interface and isolating<br>power supply to external Masimo IRMA CO2 or ISA CO2<br>measurement devices The added plug-in modules do not alter the substantial equivalence of<br>the devices. |
| Monitor software | Two software modules have been added: "Masimo O3" and "Masimo CO2" The added software modules communicate with external Masimo<br>measurement device via O3/CO2 plug-in module 867184/867185.<br>The added software modules receive physiological data from external<br>Masimo measurement device and forward it into existing, unchanged<br>SW infrastructure for presentation, data storage, user interface and<br>alarming.<br>This does not alter the substantial equivalence of the devices. |

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## 5.12 Substantial Equivalence Summary

The technological characteristics of this 510(k), the IntelliVue Patient Monitors MX500/MX550 with Masimo O3, IRMA CO2 and ISA CO2, are equivalent to the predicate devices IntelliVue Patient Monitors MX500/MX550.

Philips has additionally identified three reference devices for comparison in order to demonstrate substantial equivalence of the modified IntelliVue Patient Monitors. The tables in this summary identify the predicate and reference devices and highlight a comparison between the IntelliVue Patient Monitors MX500/MX550 (K161531, cleared July 1, 2016), Masimo O3 Regional Oximeter System (K162603, cleared May 26, 2017), Masimo Infrared Mainstream Gas Analyzer CO2 (K123043, cleared October 25, 2012), Masimo Infrared Sidestream Gas Analyzer CO2 (K171121, cleared November 17, 2017) and the proposed modifications to the IntelliVue Patient Monitors MX500/MX550.

The changes described within this 510(k) do not raise different question of safety or effect the safety or effectiveness of the devices. The risks associated with the use of the device are well characterized and do not raise different questions of safety or effectiveness. Risk analysis was performed and no new questions that could affect safety or effectiveness have been identified. Therefore, the modified devices incorporating the Masimo 03, IRMA CO2 and ISA CO2 measurements are substantially equivalent to the predicate devices.

## PERFORMANCE DATA

## 5.13 Non-Clinical Tests - Harmonized Standards

The IntelliVue Patient Monitors MX500 and MX550 has passed all safety tests for demonstrated compliance with the harmonized standards below.

| Standard | FDA Recognition # | Title # |
|---------------------------------------------------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304:2015<br>Edition 1.1<br>(consolidated<br>version) | 13-79 | Medical device software - software life cycle processes |
| AAMI/ANSI<br>ES60601-<br>1:2005/(R)2012<br>and A1:2012 (Ed.<br>3.1) | 19-4 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and<br>Essential Performance |
| IEC 60601-1-<br>2:2014 (Ed. 4.0) | 19-8 | Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety<br>And Essential Performance - Collateral Standard: Electromagnetic Disturbances -<br>Requirements And Tests |
| IEC 60601-1-<br>8:2012 (Ed. 2.1) | 5-76 | Medical Electrical Equipment - Part 1-8: General requirements for basic safety and<br>essential performance - Collateral standard: General requirements, tests and<br>guidance for alarm systems in medical electrical equipment and medical electrical<br>systems |
| ISO 80601-2-<br>55:2011 (Ed. 1) | 1-96 | Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic<br>Safety And Essential Performance Of Respiratory Gas Monitors |

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Philips Monitoring & Analytics [e-mail] [e-mail]

FDA Registration Number: 9610816

[phone]

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## 5.14 Non-clinical Bench Tests

#### Bench Testing and Shelf life

Bench testing was performed to verify system level device specifications, mechanical and electrical specifications, and packaging integrity.

The subject devices do not contain any aging components, thus, the likelihood of time-dependent product degradation is low. For this reason, a shelf life for these devices is not needed and, therefore, not specified.

Consequently, performance data is not needed to establish that device performance is maintained for the entirety of the shelf life.

The devices are not sterile, are not re-processed single use not intended for sterilization. Therefore sterilization is not evaluated for the proposed changes.

#### Biocompatibility

The subject devices do not have any contact with patients. Therefore, biocompatibility requirements are not applicable.

This is unchanged from the legally marketed predicate devices.

The legally marketed medical accessories intended for use with the subject devices, as listed in Annex E of the original 510(k), remain all unchanged. Therefore, biocompatibility aspects are not affected.

#### Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). The Philips IntelliVue Patient Monitors MX500/MX550 Software Level of Concern was determined to be Major, since a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.

#### Electromagnetic Compatibility and Electrical Safety

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the Philips IntelliVue Patient Monitors MX500/MX550. The device complies with the applicable requirements within the ANSI AAM ES60601-1 / IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

No new issues of safety or effectiveness are introduced as a result of using this device.

## 5.15 Clinical Studies

The IntelliVue Patient Monitors MX500 and MX550, like the predicate device, did not require clinical trials.

FDA recognized standards, FDA guidance documents, harmonized standards, verfication and validation, software validation, usability validation, and risk management activities have taken place for the IntelliVue Patient Monitors MX500 and MX550.

Based upon the design, intended use, indication, usability and safety testing the IntelliVue Patient Monitors MX500 and MX550 is substantially equivalent to the listed predicate device.

No new issues of safety or effectiveness are introduced as a result of using this device.

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Philips Monitoring & Analytics [e-mail] [e-mail]

FDA Registration Number: 9610816

[phone]

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## CONCLUSIONS

The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation demonstrate that the IntelliVue Patient Monitors MX500 and MX550 do not raise different questions of safety and effectiveness when compared to the predicate, performs as intended, and has performance characteristics that are substantially equivalent to the IntelliVue Patient Monitors MX500 and MX550 predicate device.

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