(264 days)
Intended Use:
The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
Indication for Use:
The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitor is only for use on one patient at a time. The monitor is not a therapeutic device. Caution: The monitor is 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 EC11).
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.
Warning: 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 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 during both no motion and motion conditions, and for patients who are well or poorly perfused.
The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside the hospital environment. It is not intended for home use.
Warning: The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).
Contraindications: There are no known contraindications for the IntelliVue MX100/X3 Patient Monitor/Multi-Measurement Module.
The Multi-Measurement Module X3 and the IntelliVue Patient Monitor MX10
0, acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The X3 and MX100 can interact with the Central Station via LAN or wireless link.
The Multi-Measurement Module X3 and IntelliVue Patient Monitor MX100 are compact, rugged, lightweight monitors with built-in invasive and non-invasive measurements, namely ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2. It can further extend the measurement capabilities when connecting to the legally marketed IntelliVue Multi-Measurement Extensions
The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor.
The provided document, an FDA 510(k) summary for the Philips IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3, describes a device that has undergone technical modifications, primarily software updates, rather than being a novel AI-powered diagnostic or assistive tool.
Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered diagnostic device, a study proving it meets those criteria, sample sizes for test and training sets, expert usage for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document focuses on demonstrating substantial equivalence to a predicate device, as per FDA 510(k) requirements. This typically involves showing that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Here's why the requested information is absent and what is discussed:
- Acceptance Criteria for AI Performance and Reported Performance: Not applicable as this is not an AI diagnostic device. The acceptance criteria mentioned are related to compliance with general medical device safety and performance standards (e.g., electrical safety, EMC, software lifecycle, usability, alarm systems).
- Sample Sizes and Data Provenance: Not applicable for AI model testing. The document states "No new issues of safety or effectiveness as compared to the predicate are introduced because of using this device," indicating that the focus was on validating the software changes within the existing framework of a patient monitor, not on an AI algorithm's diagnostic performance on a specific dataset. There is no mention of a "test set" in the context of AI performance.
- Number of Experts and Qualifications: Not applicable. Ground truth establishment for AI models is not relevant to this submission.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The device is a patient monitor, not an AI-assisted diagnostic tool that would improve human reader performance.
- Standalone Algorithm Performance: Not applicable. There is no standalone AI algorithm being assessed.
- Type of Ground Truth: Not applicable in the context of AI. The "ground truth" for this device would be the accurate measurement of physiological parameters (e.g., ECG, SpO2, NBP), which is assessed through bench testing and compliance with recognized standards, not "expert consensus" or "pathology" in the AI sense.
- Sample Size for Training Set: Not applicable. There is no AI model training described.
- How Ground Truth for Training Set Was Established: Not applicable.
What the document does demonstrate (in lieu of AI performance data):
The document primarily focuses on software changes and the continued compliance with established medical device standards to prove substantial equivalence:
- Software Changes: The key difference from the predicate device is a new software version (P.01) introducing new alarm sounds, configurable alarm management, enhancing Early Warning Score Validation, additional SpO2 fallback configuration, additional Lead Diagram presentation for ECG, and enhancement of the global "alarm off" state.
- Non-Clinical Bench Tests and Harmonized Standards: The device has passed safety tests demonstrating compliance with recognized standards like ANSI AAMI ES60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 60601-1-8 (Alarm Systems), and IEC 62304 (Medical device software lifecycle).
- No Clinical Studies: The submission explicitly states, "The subject devices, like the primary predicate devices, did not require clinical trials." This further indicates that the changes were not considered to introduce new safety or effectiveness concerns requiring human subject data for validation.
- Substantial Equivalence: The conclusion is that the modified devices "do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the predicate devices."
§ 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.