(25 days)
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 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 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 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 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 subject devices Philips IntelliVue Patient Monitor family comprises the multiparameter patient monitor models: Intelli Vue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX500, MX50, MX600, MX700, MX800 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, cardiac, medical 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 extends the capability of IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX500, MX550, MX600, MX700, MX800 by: - G7m Gas Analyzer (866173) . The legally marketed G5 Gas Analyzer Module (M1019A) used together with the IntelliVue Patient Monitors MP40 - MP90 and MX500-MX800 has been re-designed to create the new G7m Gas Analyzer Module (866173) intended for use with the Intelli Vue Patient Monitors MP40 - MP90 and MX500-MX800. When connected to a patient monitor, the G7m Gas Analyzer Module (866173) acquires airway gases of intubated patients and measures continuously carbon dioxide (CO2), oxygen (02), nitrous oxide (N20), and up to two of the automatically identified anesthetic agents Enflurane (ENF), Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV) or Desflurane (DES), and calculates the respiration rate. The IntelliVue Patient Monitors MP40 - MP90 and MX500-MX800 have additionally been modified to support the new G7m Gas Analyzer Module (866173). The modification for this purpose is limited to a minor software changes in the AGM/EGM Application Software Module (ASW). Additionally the software revision L.03 is made available for the entire IntelliVue Patient Monitors family.
The Philips IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, and MX800 with software revision L.03, and the new G7m Gas Analyzer Module (866173) underwent various verification and validation activities to demonstrate their performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device were based on various recognized consensus standards and the performance specifications cleared for the predicate devices. The document does not provide a specific table of acceptance criteria with numerical thresholds. Instead, it broadly states that "All specified pass/fail criteria have been met" and "The test results confirmed the effectiveness of the implemented design risk mitigation measures."
| Acceptance Criteria Category | Standard/Basis | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007 Ed.3 | Met the requirements of the standard, demonstrating EMC with host devices. |
| Safety and Performance | ANSI/AAMI ES60601:2005 +A1:2012, Ed. 3 (IEC 60601:2005 +A1:2012 MOD, Ed. 3); ISO 80601-2-55 First Edition 2011-12-15 (for G7m Gas Analyzer Module) | Met the requirements of these standards. |
| Mechanical Testing (for G7m Gas Analyzer Module) | IEC TR60721-4-7 Class 7M1 and IEC 60068-2-xx standard series (shock and vibration) | Met the requirements, exhibiting robustness for hospital use and handling. |
| Temperature and Humidity Testing (for G7m Gas Analyzer Module) | (No specific standard mentioned, but implies testing for climatic conditions) | Withstood simulated climatic conditions during operation and storage. |
| Software Life Cycle Requirements | IEC 62304 'Medical devices software life cycle processes', 2006 | Ensured compliance with software life cycle processes. |
| Hazard Analysis | (Not specified) | All specified pass/fail criteria met, confirming effectiveness of design risk mitigation. |
| Functional and Performance Tests of New Features | (Based on specifications cleared for predicate devices) | New features (e.g., G7m Gas Analyzer Module support) were correctly implemented and exhibited expected functionality. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the test sets in any of the V&V activities. It refers to "host devices IntelliVue -Patient Monitors MP40 to MP90, and MX500 to MX800" for EMC testing and "host devices IntelliVue Patient Monitors" for safety and performance testing of the G7m module. No information is provided regarding the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information about the number or qualifications of experts used to establish ground truth for any of the V&V activities. The tests primarily focus on engineering and compliance aspects rather than clinical expert consensus.
4. Adjudication Method for the Test Set
No adjudication method is described. The V&V activities appear to be based on objective measurements against predefined technical specifications and standards rather than subjective expert review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The documentation focuses on testing the device's adherence to technical standards and its functional performance, not on direct comparison of human reader performance with and without AI assistance. The device is a patient monitor, not an AI diagnostic tool that assists human readers in interpreting complex images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The studies described are inherently "standalone" in the sense that they evaluate the device's technical performance, safety, and functionality according to engineering standards. The focus is on the monitor's ability to accurately acquire, display, and alarm for physiological parameters, and the gas analyzer's ability to measure gases, independent of human interpretation of raw data for diagnosis. Thus, the V&V activities effectively serve as a standalone performance assessment within their scope.
7. Type of Ground Truth Used
The ground truth for the verification and validation activities was primarily based on:
- Recognized consensus standards: IEC 60601-1-2:2007 (EMC), ANSI/AAMI ES60601:2005 +A1:2012 / IEC 60601:2005 +A1:2012 (Safety), ISO 80601-2-55:2011 (Gas analyzer safety), IEC TR60721-4-7 series and IEC 60068-2-xx series (Mechanical), and IEC 62304:2006 (Software life cycle).
- Specifications cleared for the predicate devices: Performance claims and pass/fail criteria for the modified devices were benchmarked against those of previously cleared Philips IntelliVue Patient Monitors.
- Design risk mitigation measures: Effectiveness of these measures was confirmed through hazard analysis tests.
8. Sample Size for the Training Set
No training set is mentioned as this device is a patient physiological monitor and gas analyzer. It does not appear to involve machine learning or AI models that require a separate training set. The "modification for this purpose is limited to a minor software changes in the AGM/EGM Application Software Module (ASW)," suggesting traditional software development and testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.