Search Results

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), 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.

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

This document describes the Philips IntelliVue Patient Monitor MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4. The submission references a prior clearance (K221348) as the primary predicate device, indicating that the current submission is for modifications to an existing device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance in a table format with numerical values. Instead, it details that the device passed various tests related to electrical safety, EMC, wireless coexistence, software integration, software functionality within the system, essential performance, and human factors. The acceptance criterion for each of these tests is implied to be "PASSED" against recognized consensus standards and internal requirements.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for any of the tests mentioned (e.g., how many devices were tested for electrical safety, or how many users were involved in human factors testing). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests described are primarily engineering and software validation tests rather than clinical studies requiring expert ground truth for interpretation. For "Human Factors," it would involve users, but their qualifications and numbers are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. The nature of the tests (compliance with standards, software functionality) suggests that a formal adjudication method like 2+1 or 3+1 for ground truth establishment, typical in clinical studies, would not be applicable here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a patient monitor with software enhancements, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document indicates "Software Testing" was performed, which would involve testing the algorithms and functionalities of the software in a standalone manner. However, it's not a standalone diagnostic algorithm in the typical sense; it's the core operating software of the patient monitor. The new features like "new alarm sounds," "Visual Patient feature," and "configurable alarm management" were tested for their functionality and integration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests described is primarily based on:

• Recognized consensus standards: For electrical safety (IEC 60601-1, IEC 60601-1-8, IEC 62304), EMC (IEC 60601-1-2).
• System requirements/specifications: For software integration, software functionality, and essential performance.
• Usability principles: For Human Factors testing.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as these are non-clinical hardware and software validation tests.

8. The sample size for the training set:

This information is not applicable as this document does not describe an AI or machine learning model that requires a training set. The changes described are software updates for existing functionalities and introduction of new display/alarm features, not the development of a predictive algorithm from data.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as point 8.

Ask a specific question about this device