FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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 MP5 and 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 MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

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 Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

The SSC Sepsis Protocol, in the Protocol Watch 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 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 transcutaneous gas measurement (tcGas) with the M1018A plug-in module 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 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.

Device Description

The IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 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 monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis.

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. Several monitor models can also be used mobile, during patient transport inside or outside of hospitals.

The monitors have a color display with touch-screen and/or keys and a navigation point as a primary input device. They also support further local input devices such as specialized remote control, keyboard, and mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

With the current software Rev. N.0 the following modifications have been introduced:

Implementation of the existing feature Alarm Advisor into the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3. Alarm Advisor provides feedback on recurring and continuous alarm limit violations based on configured criteria. The information provided by the Alarm Advisor supports device operator in adapting alarm limits more specifically. This is the same functionality as that in other IntelliVue Patient Monitors: MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, and MX800 (cleared with K161531).
Modification of a few specific elements of the Graphical User Interface (GUI) of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, and the Intelli Vue Multi-Measurement Module X3:
- The key 'Silence' has been renamed to 'Acknowledge',
- A new default configuration for the Pause/Switch off of alarms via 'Acknowledge' key combined with a specific pop-up window has been added to all monitor models,
- New default configurations of visual alarm indicators with other colors and flashing behavior of the alarm numerics and limits have been added.

AI/ML Overview

The provided document is a 510(k) premarket notification from Philips Medizin Systeme Boeblingen GmbH to the FDA for their IntelliVue Patient Monitors. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and addressing minor software modifications, specifically the implementation of an "Alarm Advisor" feature and GUI changes related to alarm management.

The document does not contain the specific details required to answer all parts of your request, particularly regarding clinical performance studies with specific acceptance criteria, sample sizes for test and training sets, expert consensus, or MRMC studies for an AI device. This is because the submission is for a patient monitor and its software updates, not an AI-powered diagnostic device in the sense that would require such extensive clinical validation to demonstrate improved human reader performance or standalone algorithm performance.

However, I can extract information related to the acceptance criteria and study proving the device meets its acceptance criteria, based on the scope of this type of submission.

Here's an analysis based on the provided text, while acknowledging the limitations for a full AI device performance study:

Acceptance Criteria and Device Performance (as evident from this 510(k) submission):

For this type of device (patient monitors with software updates), the "acceptance criteria" and "device performance" are primarily demonstrated through compliance with recognized standards, hazard analysis, and functional/regression testing rather than a clinical trial with a defined performance metric like sensitivity/specificity for a diagnostic AI.

Acceptance Criterion (Implicit/Explicit)	Reported Device Performance (Summary)
Safety: Device operates without introducing new hazards or increasing existing risks.	"All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures." "All specified test requirements have been met and no new hazards have been identified."
Usability: User interface is intuitive and effective, especially for new features or changes.	"Evaluated and improved iteratively during the design phase conducting several formative usability evaluations. They included established usability engineering methods like focus groups, expert reviews and usability tests using user interface prototypes. User feedback was translated into iterative user interface improvements."
Functionality: New features (Alarm Advisor, GUI changes) operate as designed and specified.	"Functional tests... with feature Alarm Advisor at System Level. All tests have been passed." "Functional tests... with the feature blinking behavior of numerics at System Level. All tests have been passed." "Functional tests... with the feature Alarm Acknowledge at System Level. All tests have been passed." "Functional tests... with the feature Pause/Switch off Alarms at System Level. All tests have been passed. The performed functional tests demonstrate that the new features... are correctly presented on the display, can be correctly operated, controlled, configured, and function as specified and according to the labeling claims."
Reliability/Maintain Existing Functionality: Unchanged functions continue to work correctly after software modifications.	"Regression tests... All tests have been passed. The performed regression tests demonstrate that the unchanged and not affected functions also work correctly and in accordance with all specifications and labeling claims in the modified software."
Compliance with Standards: Adherence to relevant medical device and software standards.	"Testing according to the recognized consensus standard: IEC 60601-1-8: 2012 (Ed. 2.1) (Alarms) - All applicable requirements have been met." "Compliance with the recognized consensus process standards: AAMI ANSI IEC 62304:2006 (Ed. 1) (Software life cycle processes); IEC 60601-1-6: 2013 (Ed. 3.1) (Usability). The modified devices are compliant with all applicable requirements of the above stated process standards."
Substantial Equivalence: Device performs similarly to predicate devices.	"Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence." "The results demonstrate that the Philips IntelliVue Patient Monitors... meet all defined reliability requirements and performance claims."

Study Details (based on the provided document):

Given that this is a 510(k) for patient monitors with minor software updates, the "study" is primarily a series of verification and validation (V&V) activities focused on engineering and software aspects, rather than a clinical trial for an AI diagnostic.

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a "test set" in the context of a dataset for an AI model. Instead, it refers to V&V activities that include:
  - Hazard Analysis Testing: "All specified pass/fail criteria have been met." (No specific sample size of incidents/scenarios mentioned, typically an engineering analysis).
  - Functional System Level Tests: Performed on a variety of monitor models (MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, Multi-Measurement Module X3) for the new features (Alarm Advisor, blinking numerics, Alarm Acknowledge, Pause/Switch off Alarms). No specific number of test cases or "patients" is provided.
  - Regression Tests: Performed on the same range of monitor models to ensure unchanged functions still work.
- Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The tests are performed on the device itself and its software.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not described as "ground truth" establishment in this context. For usability testing, it mentions "expert reviews" as part of formative evaluations, but the specific number and qualifications of these experts are not detailed. These would typically be human factors engineers, clinical specialists, or design experts.
Adjudication Method for the Test Set:
- Not applicable as there is no "test set" of clinical cases requiring adjudication. The V&V activities are based on engineering specifications and standard compliance.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This submission is for patient monitors and their alarm management and GUI features, which do not involve diagnostic interpretation in that manner. The "Alarm Advisor" provides feedback on alarm limit violations, which is a clinical decision support tool related to device settings, not an image interpretation aid.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
- Yes, to an extent, in the sense that the new software features were functionally tested independently of human interaction (e.g., "Functional tests... All tests have been passed"). The "Alarm Advisor" functionality and GUI changes needed to perform as specified by the algorithm/software design. However, this is not a "standalone performance study" in the context of an AI diagnostic that might output a diagnosis or risk score. It's more about verifying software logic and output.
The Type of Ground Truth Used:
- Engineering Specifications and Standards Compliance. For the new features and existing functionalities, the "ground truth" is whether the software performs according to its design specifications, established industry standards (e.g., IEC 60601-1-8 for alarms), and internal quality requirements. For usability, "user feedback" (from focus groups, usability tests) serves as the basis for improvement.
The Sample Size for the Training Set:
- Not applicable. This device is not an AI model that undergoes a "training phase" from a clinical dataset in the traditional machine learning sense. The software development process involves design, coding, and V&V activities.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.

Summary

Regulation Number and Section

§ 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.