(73 days)
The Philips IntelliVue MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX450, MX500, MX550, MX600, MX700 and MX800 patient monitors with software revision L.02 and the Philips IntelliVue X1(M3001AL) and X2 Multi-Measurement Module with software revision L.02 are indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.
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. They are intended for use by trained healthcare professionals in a hospital environment.
The MP2 and X2 are also intended for use during patient transport inside of the hospital environment. The MP5, MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MX400/MX450/MX550 are additionally intended for use in transport situations within hospital environments. The MP20/MP30/MP40/MP50 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 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 transcutaneous gas measurement (tcGas) 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 Protocol Watch clinical decision support tool, is intended for use with adult patients only.
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 Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.
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 with patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The subject devices Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: IntelliVue Patient Monitors MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX400, MX450, MX500, MX550, MX600, MX700, MX800 and IntelliVue X1(M3001AL) and X2 Multi-Measurement Module that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules.
The monitors acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.
The monitors offer a monitoring solution optimized for the surgical, cardical and neonatal care environments. They are located in the patient vicinity at the bedside. The monitors can also be used mobile, during patient transport in a hospital setting.
The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure.
The monitors have a color display with touch-screen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. One external display, which provides an adaptive duplicate image of the primary display, can be connected to a built-in video port.
The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.
The subject modification introduces the Masimo rainbow SET® technology as a further SpO2 option for the Philips IntelliVue MP2 and MP5/MP5SC Patient Monitor and for the Philips IntelliVue X1(M3001AL) and X2 Multi-Measurement Modules.
Additionally the software revision L.02 is made available for the entire IntelliVue Patient Monitors family.
This is a Philips IntelliVue Patient Monitoring System (Multiple Models) (K150975).
Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance standards that the device was verified against, indicating that meeting these standards served as the acceptance criteria. The document states that all specified pass/fail criteria have been met.
| Standard / Performance Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Basic Safety and Essential Performance (AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012) | Compliance with this standard to ensure the device is safe for patient use and performs its essential functions without unacceptable risk. | "all specified pass/fail criteria have been met." |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | Compliance with this standard to ensure the device operates correctly in its intended electromagnetic environment and does not cause undue electromagnetic interference. | "all specified pass/fail criteria have been met." |
| Multiparameter Patient Monitoring (IEC 60601-2-49:2011) | Compliance with this standard for the specific requirements of multiparameter patient monitoring equipment, covering aspects like alarm systems, display of physiological parameters, and accuracy. | "all specified pass/fail criteria have been met. The results demonstrate that the Philips IntelliVue patient monitors and IntelliVue Multi-Measurement Modules meet all safety and reliability requirements and performance claims." |
| SpO2 Monitoring (ISO 80601-2-61:2011) | Compliance with this standard for the basic safety and essential performance of pulse oximeter equipment, including accuracy of SpO2 measurements. The specific accuracy levels are not detailed, but the general requirement is to meet the standard. | "all specified pass/fail criteria have been met. The results demonstrate that the Philips IntelliVue patient monitors and IntelliVue Multi-Measurement Modules meet all safety and reliability requirements and performance claims." |
| Software Life Cycle Processes (IEC 62304:2006) | Compliance with this standard for the software development lifecycle, ensuring appropriate processes for development, maintenance, and risk management of medical device software. This includes conducting "Software verification and validation testing." | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... Testing... was conducted and all specified pass/fail criteria have been met." |
| Hazard Analysis Risk Mitigation | Demonstrated effectiveness of implemented design risk mitigation measures as identified through hazard analysis. This implies all identified hazards have been adequately mitigated to an acceptable level, and the effectiveness of these mitigations was confirmed through testing. | "The test results confirmed the effectiveness of the implemented design risk mitigation measures." |
| Substantial Equivalence | The modified devices (Philips IntelliVue Patient Monitors and Multi-Measurement Modules with software Rev. L.02, including the Masimo rainbow SET® technology) have the same technological characteristics and intended use as the legally marketed predicate devices, and that testing confirms they are "substantially equivalent." | "Pass/Fail criteria were based on the specifications cleared for the predicate devices and all test results showed substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of patients or data points) used for the test set(s). It mentions "testing involved system level and as well as testing from the hazard analysis." It also indicates that "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
The data provenance (e.g., country of origin, retrospective or prospective) for the test sets is not specified in the provided text. The testing seems to be focused on meeting technical standards rather than involving clinical performance with patient data explicitly described in this section.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described appears to be primarily technical verification and validation against established engineering and safety standards, rather than clinical outcome-based ground truth established by medical experts for a comparative study.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the testing described (compliance with standards, hazard analysis), an adjudication method for a test set in the traditional sense of clinical data interpretation by experts is unlikely to have been part of these specific tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The submission focuses on device modifications and their compliance with safety and performance standards for substantial equivalence, not on comparing reader performance with or without the device's AI capabilities.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the overall device includes software and algorithms, the studies described are for system-level verification and validation. There isn't an explicit standalone performance study of a particular algorithm described in the provided text that would assess its performance independent of the human user. The performance is assessed in the context of the entire patient monitoring system meeting established standards.
7. Type of Ground Truth Used
The "ground truth" for the tests appears to be defined by:
- Established engineering and safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 80601-2-61, IEC 62304.
- Specifications cleared for predicate devices: "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
- Hazard analysis: Ensuring the effectiveness of risk mitigation measures.
There's no mention of ground truth established by expert consensus, pathology, or direct outcomes data in the context of the verification and validation activities described.
8. Sample Size for the Training Set
This information is not provided. The document describes software verification and validation, but it does not detail any machine learning or AI models that would require a distinct "training set." The software is being updated (revision L.02), and a new SpO2 technology (Masimo rainbow SET) is being integrated, but the details of any related training data are absent.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" for an AI model is mentioned or described, the method for establishing its ground truth is not applicable/provided in this document.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.