(80 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 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 ECI1).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
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 Patient Monitor MX400 and MX450 is a modification of the legally marketed IntelliVue Patient Monitor MP30.
The MX400 and MX450 are display units with a TFT LCD flat panel display and built-in CPU. The models MX400 and MX450 differ only in the size of their flat panel displays: MX400 has a 9" and MX450 has a 12" display.
The MX400 and MX450 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module and any one of the M3012A, M3014A, M3015A/B or M3016A Measurement Server Extensions, as well as to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO.
The MX400 and MX450 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 MX400 and MX450 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital.
The MX400 and MX450 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.
The MX400 and MX450 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN.
This is a description of the acceptance criteria and study for the Philips IntelliVue Patient Monitor MX400 and MX450.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical performance metrics against predefined acceptance criteria for novel functionalities. The acceptance criteria described are broad and relate to safety, effectiveness, and adherence to established standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and General Performance | |
| Adherence to IEC 60601-1-2:2001 +A1:2004 (EMC) | All applicable requirements have been met. |
| Adherence to IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety) | All applicable requirements have been met. |
| Adherence to IEC 60601-1-8:2003 (Alarms) | All applicable requirements have been met. |
| Adherence to IEC 62304:2006 (Software life cycle processes) | All applicable requirements have been met. |
| Environmental testing (temperature, humidity, shock, vibration, free fall) | All specified test requirements have been met. The tests confirmed that the device worked safely and according to specifications and indicated claims during tests simulating general hospital conditions, handling, transport, and storage. |
| Functional Performance (Regression Testing) | |
| Functionality of all physiological measurement parameters (unchanged from predicate) | All specified criteria have been met. The tests demonstrated that the device worked safely, effectively, and correctly in accordance with specifications and labeling claims. |
| Functionality of integrated recorder | All specified criteria have been met. |
| Functionality of display | All specified criteria have been met. |
| Functionality of battery (operating and charging time) | All specified criteria have been met. |
| Functionality of human interface | All specified criteria have been met. |
| Functionality of external interfaces | All specified criteria have been met. |
| Functionality of alarming system | All specified criteria have been met. |
| White box tests (identified by hazard analysis) | All specified criteria have been met. |
| Overall Equivalence to Predicate Device | |
| Pass/Fail criteria based on specifications cleared for the predicate device | Test results showed substantial equivalence. |
| Meeting all defined reliability requirements and performance claims | The results demonstrate that the device meets all defined reliability requirements and performance claims. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify a "test set" in the context of patient data or clinical trials. The testing described primarily involves engineering and system-level verification and validation (V&V) activities. Therefore, there is no sample size for a test set of patient data, nor is there information on data provenance (e.g., country of origin, retrospective/prospective). The validation focuses on the device's adherence to technical standards and its functional performance when connected to existing, already cleared measurement modules.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The validation described is not a clinical study requiring expert interpretation of medical data to establish ground truth. It is a technical V&V process ensuring the device's proper functioning and adherence to standards.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons mentioned in point 3.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission is for a modification of an existing patient monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. Standalone Performance
The concept of "standalone performance" (algorithm only without human-in-the-loop) is not directly applicable in the context of this traditional patient monitor device. The device itself is a monitor that displays physiological parameters measured by external modules. Its "performance" is evaluated based on its ability to accurately acquire, display, and manage data from these modules, and adhere to safety and functional standards. The summary details regression testing which essentially verifies the standalone functioning of the device's internal components, software, and interfaces according to its specifications.
7. Type of Ground Truth Used
The "ground truth" for the verification and validation activities described in the 510(k) summary are primarily:
- Recognized consensus standards: IEC 60601-1-2, IEC 60601-1, IEC 60601-1-8, IEC 62304.
- Specifications cleared for the predicate device: The MX400 and MX450's performance was compared against the established specifications and performance of the legally marketed IntelliVue Patient Monitor MP30.
- Internal design specifications: The device's own defined specifications for its functions, such as battery operating time, display functionality, and interface performance.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's V&V.
8. Sample Size for the Training Set
This information is not applicable. The IntelliVue Patient Monitor MX400 and MX450 are hardware devices with software, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons mentioned in point 8.
§ 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.