IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)

K231671 · Philips Medizin Systeme Boeblingen GmbH · MHX · Dec 19, 2023 · Cardiovascular

Device Facts

• Record ID: K231671
• Device Name: IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Device Story

IntelliVue MX750/MX850 are multiparameter patient monitors for hospital use by trained healthcare professionals. They acquire physiological signals (ECG, EEG, SpO2, etc.) via connected modules and sensors. The device processes these inputs to display waveforms, numerics, and an animated 'Visual Patient' avatar. It generates alarms for physiological parameters. Modifications include 'Philips 2021' alarm sounds, a Visual Patient avatar for intuitive data presentation, and configurable alarm management with user authentication. The device provides real-time monitoring to assist clinicians in patient assessment; it does not provide therapy. The system is intended for stationary use in hospital environments.

Clinical Evidence

No clinical data or trials were required. Substantial equivalence is supported by non-clinical bench testing, including electrical safety, EMC, wireless coexistence, software integration, regression testing, and human factors engineering. All tests passed.

Technological Characteristics

Multiparameter patient monitor; software-based processing; connectivity via standard hospital networks. Hardware remains unchanged from predicate. Software version P.01. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-8 (alarms), IEC 62304 (software lifecycle), and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for use by healthcare professionals for monitoring physiological parameters of adult, pediatric, and neonatal patients. Not for therapeutic use. Prescription only. ECG for diagnostic rhythm/morphology (AAMI EC 11). ST segment monitoring for adults only. BIS for EEG monitoring/anesthetic effect guidance in adults/pediatrics. SSC Sepsis Protocol for adults. IPI for pediatric (1-12 years) and adult patients. PPV for sedated, mechanically ventilated adults free from arrhythmia. NMT for neuromuscular transmission monitoring in adults/pediatrics. Masimo rainbow SET for SpO2, pulse rate, SpCO, SpMet, SpHb, and RRac. Masimo O3 for cerebral rSO2 in adults ≥40kg and pediatrics >5kg/<40kg. SedLine for EEG-based brain state monitoring in adults (≥18 years) in OR, ICU, and clinical research labs. Not for transport or home use.

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 Monitor MX750 (K221348)
• IntelliVue Patient Monitor MX850 (K221348)
• IntelliVue 4-Slot Module Rack FMX-4 (K221348)

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). On the left is the Department of Health and 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.

December 19, 2023

Philips Medizin Systeme Boeblingen GmbH Siegfried Breitling Regulatory Affairs Specialist Hewlett-Packard-Strasse 2 Boeblingen, BW 71034 Germany

Re: K231671

Trade/Device Name: IntelliVue Patient Monitor MX750 (866471), Intelli Vue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) 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, BZC, BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRT, DSF, DSJ, DSK, DXN, FLL, GWQ, GWS, KLK, KOI, LKD, MLD, MSX, NHO, NHP, NHQ Dated: November 17, 2023 Received: November 17, 2023

Dear Siegfried Breitling:

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/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}------------------------------------------------

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

# K231671

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

IntelliVue 4-Slot Module Rack FMX-4 (866468)

Indications for Use (Describe)

Intended Use:

The devices are 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 monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

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

The monitors are 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.

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 quide 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 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),

{4}------------------------------------------------

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.

The monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for use in transport situations.

They are not intended for home use.

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.

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.

# K231671 510(k) Summary

| Submitter/Owner | Philips Medizin Systeme Böblingen GmbH<br>FDA Establishment Number 9610816<br>Hewlett-Packard-Str. 2<br>71034 Böblingen<br>Germany | | | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------------------------------------------------------|-----------------|
| | Phone: [phone] | | | |
| Trade Name | IntelliVue Patient Monitor MX750<br>IntelliVue Patient Monitor MX850<br>IntelliVue 4-Slot Module Rack FMX-4 | | | |
| 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 | | | |
| Predicate Device | 510(k) No. | Company | Device Name | Product<br>Code |
| K221348 is the primary<br>predicate device. | K221348 | Philips | IntelliVue Patient Monitor MX750<br>IntelliVue Patient Monitor MX850<br>IntelliVue 4-Slot Module Rack FMX-4 | MHX |

| Intended Use and<br>Indications for Use | Intended Use: |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The modified IntelliVue<br>Patient Monitors MX750<br>and MX850 have the same<br>intended use and<br>indications as the legally<br>marketed predicate device. | The devices are intended to be used for monitoring and recording of, and to<br>generate alarms for multiple physiological parameters of adults, pediatrics,<br>and neonates. |
| | Indications for Use: |
| | The monitors are indicated for use by health care professionals whenever<br>there is a need for monitoring the physiological parameters of patients. |
| | The monitors are only for use on one patient at a time. |
| | The monitors are not therapeutic devices. |
| | The monitors are for prescription use only. |
| | The ECG measurement is intended to be used for diagnostic recording of<br>rhythm and detailed morphology of complex cardiac complexes (according<br>to AAMI EC 11). |
| | ST segment monitoring is intended for use with adult patients only and is<br>not clinically validated for use with neonatal and pediatric patients. |
| | |
| BIS is intended for use under the direct supervision of a licensed health<br>care practitioner or by personnel trained in its proper use. It is intended<br>for use on adult and pediatric patients within a hospital or medical facility<br>providing patient care to monitor the state of the brain by data acquisition<br>of EEG signals. The BIS may be used as an aid in monitoring the effects of<br>certain anesthetic agents. Use of BIS monitoring to help guide anesthetic<br>administration may be associated with the reduction of the incidence of<br>awareness with recall in adults during general anesthesia and sedation. | |
| The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support<br>tool, is intended for use with adult patients only. | |
| The Integrated Pulmonary Index (IPI) is intended for use with adult and<br>pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not<br>intended to replace vital sign monitoring. The IPI is an adjunct to and not<br>intended to replace vital sign monitoring. | |
| The derived measurement Pulse Pressure Variation (PPV) is intended for<br>use with sedated patients receiving controlled mechanical ventilation and<br>mainly free from cardiac arrhythmia. The PPV measurement has been<br>validated only for adult patients. | |
| The IntelliVue NMT Module is intended to be used as an objective<br>neuromuscular transmission monitor, using accelerometry for measuring<br>the muscle contraction following an electrical stimulation of a peripheral<br>nerve. The NMT Module is intended to be used with adult and pediatric<br>patients. | |
| The Masimo rainbow SET measurement is indicated for the noninvasive<br>monitoring of functional oxygen saturation of arterial hemoglobin (SpO2),<br>pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin<br>saturation (SpMet), total hemoglobin concentration (SpHb), and/or<br>respiratory rate (RRac). The Masimo rainbow SET measurement is<br>indicated for use during both no motion and motion conditions, and for<br>patients who are well or poorly perfused. | |
| The noninvasive Masimo O3 Regional Oximeter System and accessories<br>are intended for use as an adjunct monitor of absolute and trended<br>regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral<br>region under the sensors. The Masimo O3 Regional Oximeter System and<br>accessories are indicated for use on adults ≥40 kg and on pediatrics >5 kg<br>and <40 kg in healthcare environments. | |
| The SedLine Sedation Monitor is intended to monitor the state of the brain<br>by real-time data acquisition and processing of EEG signals. The system<br>includes the Patient State Index (PSI), a proprietary computed EEG variable | |
| that is related to the effect of anesthetic agents. The agents include:<br>Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol,<br>Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended<br>for use with adult patients (18 years of age and older) in the operating<br>room (OR), intensive care unit (ICU), and clinical research laboratory. | |
| The monitors are intended for use by trained healthcare professionals in a<br>hospital environment.<br>They are not intended for use in transport situations.<br>They are not intended for home use. | |

Image /page/5/Picture/6 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble water or sound waves. Above and below the waves, there are two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield.

{6}------------------------------------------------

Image /page/6/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 horizontally and takes up most of the frame. The background is plain white.

Image /page/6/Picture/4 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield is a white circle with two wavy lines across the middle. There are also two four-pointed stars, one above the wavy lines and one below. 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 the primary focus of the image and is set against a white background.

| Summary of Reason for<br>Notification | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------|
| The reason for this traditional 510(k) submission is to: | |
| Notify FDA on modifications carried out on the IntelliVue Software, | |
| | which is the software platform common to the legally marketed Philips |
| | IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 |
| | (K221348). The software changes resulted in a new IntelliVue Software |
| | version, bringing these devices to software version P.01. |

Image /page/7/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield are two wavy lines and four stars. The word "PHILIPS" is written in white at the top of the shield.

{8}------------------------------------------------

## 1. Description of the Subject Devices: IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4

All features and technological characteristics of the primary predicate IntelliVue Patient Monitors MX750 (866471), MX850 (866470) and IntelliVue 4-Slot Module Rack FMX-4 (866468) remain unchanged and are still applicable to the IntelliVue Patient Monitors, subject of this submission.

The proposed modifications for the IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4 include:

- 1) A new software version, designated as IntelliVue Software P.01. The new software version introduces following new features:
- . New alarm sounds designated as "Philips 2021" sounds, based on a joint development of Philips and Sen Sound researchers who focus on transforming the experience of sound in healthcare.
- . New Visual Patient feature, which displays patients's vital signs in an animated patient avatar alongside the conventional vital sign waveforms and numerics.
- . configurable alarm management, limiting changes in alarm settings to pre-defined authorized personnel.

It further enhances following existing features

- Manual Selection of QRS /Pulse Tone
- Introduction of Lead Diagram for ECG
- . Enhancement of Visual Presentation for "Global Alarm Off" State

| Model Number | Product Name / Description |
|--------------|-------------------------------------|
| 866471 | IntelliVue Patient Monitor MX750 |
| 866470 | IntelliVue Patient Monitor MX850 |
| 866468 | IntelliVue 4-Slot Module Rack FMX-4 |

## Table 1 - Device Identifying Information

Image /page/8/Picture/16 description: The image shows the Philips logo. The logo is blue and white. The word "PHILIPS" is in blue at the top of the logo. Below the word is a white shield shape with two wavy lines and four stars inside.

{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. The background is white.

## 1.1 Discussion of Similarities and Differences

### Intended Use and Indications for Use

Intended use and indications for use of the modified IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 are the same as those of the primary predicate IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 .

#### Environment of Use, Intended Users

All subject and predicate devices are intended for use inside hospital environments.

All subject and predicate devices are for use by trained healthcare professionals.

In summary, the environment of use and intended users of the subject devices IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 is the same as those of their predicate devices.

### Technological Characteristics

The device design, materials and energy sources of the modified IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 are the same as those of their predicate IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4.

The software of the IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 was slightly changed in order to:

- further enhance some of the existing functionalities, i.e re-design of existing alarm sounds o (adding the Philips 2021 sounds), enabling the user authentication capability, limiting the access to Early Warning Score (EWS) data and allow for user validation of the data by means of authentication, additional configuration for manual selection of QRS /Pulse Tone, additional lead diagram for ECG and the enhanced presentation of the "Global Alarm off" state.
- o include an additional form of vital signs presentation, which presents physiological parameters in a more intuitive way, by means of an animated patient avatar i.e Visual Patient feature.

## Other key technological features

The proposed modification does not introduce any new hardware features.

Operating principle, mechanisms of action and human interface are unchanged from the predicate devices.

All accessories of the legally marketed predicate devices IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 are re-used without any change.

The physiological measurements of the legally marketed IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 remain unchanged.

Image /page/9/Figure/20 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 blue 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 white.

Performance specifications of all supported measurements remain unchanged by the proposed modification.

In summary, key technological features are mostly unchanged, and the modifications do not raise any different questions of safety and effectiveness as compared to the predicate device.

Image /page/10/Picture/5 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a white, sans-serif font above a blue shield-like shape. Inside the blue shape, there is a white background with two wavy lines and four stars. The wavy lines are arranged horizontally, and the stars are positioned above and below the lines.

{11}------------------------------------------------

## 2. Summary of Performance Testing

The following table provides an overview how the proposed modification has been verified:

### Table 1 - Summary of Performance Testing

| Test Name | Test Description | Attachments | Result |
|----------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Electrical Safety Testing | Tested to recognized consensus standards<br>IEC 60601-1<br>IEC 60601-1-8<br>IEC 62304 | "IEC 60601-1 Test Report"<br>TR: 282234-TL4-1<br>"IEC 60601-1-8 Test Report"<br>TR: 291778-TL4-16<br>“IEC 62304 Test Report"<br>TR: 291778-TL4-20 | PASSED |
| EMC Testing | Tested to recognized consensus standard<br>IEC 60601-1-2<br>Tested against common EM emitters | "EMC Test Report"<br>TR: 2021113-02-I | PASSED |
| Wireless Coexistence | Test sensitivity of patient monitors to<br>common interferers | "Wireless Coexistence Test Report" | PASSED |
| Software Integration Testing | Test of new functionality integration into<br>existing software infrastructure | "Test Report for Integration Testing" | PASSED |
| Software Testing | Test of new software functionality | "Test Report for System Requirements Testing"<br>"Test Report for Safety Risk Assessment"<br>"Test Report for Regression Testing"<br>"Test Report for Security Risk Assessment"<br>"Test Report for Compatibility Testing" | PASSED |
| Essential Performance<br>Testing | Tests verifying that essential performance<br>requirements are met. | For Patient Monitors:<br>“Monitor EP Verification Report1"<br>"Monitor EP Verification Report2" | PASSED |
| Human Factors | Test of device usability | "Human Factors Engineering Report" | PASSED |

Image /page/11/Picture/7 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" written at the top. Inside the shield is a white circle with two wavy lines and two stars.

{12}------------------------------------------------

Image /page/12/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.

### Table 3 - Summary of non-clinical and clinical testing

| 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<br>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<br>equivalent to the listed predicate devices. |
| No new issues of substantial equivalence are introduced as a result of using this device. |

Image /page/12/Picture/5 description: The image contains the Philips logo. The logo is a blue oval with the word "PHILIPS" written in white at the top. Inside the oval, there are two wavy lines and four stars. The stars are arranged in a diamond shape, with one star at the top, one at the bottom, and one on each side.