(261 days)
The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms.
The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult patients.
The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate data of adult patients for a clinical information management system.
The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device.
The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm).
The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor.
Warning:
Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated.
The new IntelliVue CL Respiration Pod is a small body-worn, cableless, battery powered, respiration rate and pulse rate measuring and intermittent monitoring device. It uses specifically designed adhesive attachment (Mobile CL Resp Attachment), which holds the CL Respiration Pod at the patient chest.
The CL Respiration Pod provides and communicates measurements values and other information (e.g. battery state) wirelessly via Short Range Radio (SRR) to an assigned compatible IntelliVue Patient Monitor or IntelliVue GuardianSoftware. It can also provide basic information on posture (like supine, prone, upright etc.) and, activity status of the patient. The CL Respiration Pod can be controlled from the assigned IntelliVue Patient Monitor or IntelliVue GuardianSoftware.
The modified IntelliVue Patient Monitor models MP2, X2, MP5, MP5T, and MP5SC consist of a display unit including built-in central processing unit (CPU) and multiple physiological measurements. All monitors share the same architecture of CPU units and exactly the same software is executed on each monitor. The monitors measure physiological parameters such as: Sp02, pulse, ECG, arrhythmia, ST, QT, respiration, invasive and non-invasive blood pressure, temperature, CO2, spirometry, C.O., CCO, and BIS. They generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to the central station. These monitor models are robust, portable, lightweight, compact in size and modular in design, with interfaces to dedicated external measurement devices.
The modified IntelliVue GuardianSoftware is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue patient monitors. The IntelliVue GuardianSoftware provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue GuardianSoftware is software only product intended to be installed on a customer supplied PC or Server.
The Philips IntelliVue CL Respiration Pod device underwent verification and validation (V&V) activities that included clinical and bench performance tests, clinical usability, electrical safety, EMC, system level, functionality, and regression, environmental, mechanical, and radio tests. The tests aimed to establish the performance, safety, functionality, usability, effectiveness, and reliability characteristics of the new device and the modified compatible IntelliVue Patient Monitors and IntelliVue GuardianSoftware. The results of these tests demonstrated that the new Philips IntelliVue CL Respiration Pod and its accessories are as safe, effective, and perform as well as the predicate devices.
1. Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Acceptance Criteria (Specifications) | Reported Device Performance |
|---|---|---|
| Respiration Rate | Accuracy, Resolution, and Signal Quality met defined specifications within the whole measurement range. | Low standard deviation (less than 2 rpm) between the subject device and the predicate device (MP2 monitor) in the specified measurement range (5 to 60 rpm). |
| Pulse Rate | Accuracy, Resolution, and Signal Quality met defined specifications within the whole measurement range. Performance for rapid, irregular heart rates not clinically validated above 110 bpm. | Low standard deviation (less than 3 bpm) between the subject device and the predicate device (MP2 monitor) in the specified measurement range (30 to 220 bpm) and for regular pulse rates up to 110 bpm for irregular heart rates. Pulse rate calculation algorithm similarity to predicate for applied irregular heart rate episodes. |
| Patient Posture | Substantial equivalence to the Respironics Alice PDx (K090484). | Tests demonstrated substantial equivalence. |
| Activity Status | Substantial equivalence to the Respironics Actical (K060919). | Tests demonstrated substantial equivalence. |
| Usability/Wearability | All defined pass criteria were met for acceptance and effectiveness of design, wearing comfort, and user-friendliness of the Mobile CL Resp Attachment. | All defined pass criteria were met. |
| Non-Clinical Performance (Bench Testing) | Verification of respiration rate and pulse rate range, accuracy, resolution, signal quality, basic patient posture, and activity against specifications and predicate devices. | Test results demonstrated that all defined specifications were met and substantial equivalence to predicate devices was shown. |
| Clinical Performance | Substantial equivalence to the predicate IntelliVue Patient Monitor MP2 with respect to physiological measurement parameters (respiration rate and pulse rate). | The device measures respiration rate and pulse rate as accurately as the predicate MP2 monitor and the pulse rate calculation algorithm performs as accurately as the predicate MP2 monitor for irregular heart rate episodes. |
| Safety & Effectiveness | Compliance with recognized consensus standards (IEC 60601-1-2, AAMI/ANSI ES 60601-1, IEC 62304, IEC 60601-1-8) and hazard analysis criteria. | All applicable requirements and specified pass/fail criteria were met, confirming effectiveness of risk mitigation. |
| Functionality & Regression | Safe, effective, and according to specifications and Instructions for Use in the intended environment for the new Respiration Pod and modified compatible devices. | All specified criteria were met, confirming safe and effective functioning according to specifications. |
| Environmental & Mechanical | Safe operation and adherence to specifications during/after tests simulating general hospital conditions, transport, rough handling, and storage. | All specified test requirements were met, confirming safe and according to specifications. |
| Radio Frequency (RF) Wireless Communication | Correct, reliable functioning of radio-related features according to specifications in the intended environment of use. | All specified test requirements were met, confirming correct and reliable functioning. |
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Performance Test (First series): 39 patients (26 male and 13 female) aged between 16 and 86 years were evaluated. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated but implies a prospective clinical study in a controlled environment.
- Clinical Performance Test (Second series): Eight 35-minute episodes showing irregularity in heart rate were selected from the AHA arrhythmia database. This indicates a retrospective analysis of existing, publicly available dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not explicitly state the number of experts or their qualifications for establishing ground truth during the clinical performance tests. However, the first series of clinical tests compared the device's readings with a "predicate device's respiration rate and heart rate," implying the predicate device (Philips IntelliVue Patient Monitor MP2) served as the reference standard. For the second series, "annotated ECG traces from the AHA arrhythmia database" were used, where annotations are established by cardiologists or other qualified medical professionals who are specialists in arrhythmia analysis.
4. Adjudication Method for the Test Set:
The document does not mention any specific adjudication method (e.g., 2+1, 3+1). For the first series of clinical tests, a "head to head comparison" was performed, and the Bland-Altman statistical method was used for analysis. For the second series, the "curve progression" of the pulse rate traces from the subject device was compared to the heart rate traces from the annotated ECGs of the predicate device. This suggests a direct comparison against a reference, rather than an adjudication process involving multiple human readers for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated or implied. The clinical testing focused on the device's performance against a predicate device and annotated databases, rather than assessing improvements in human reader performance with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance evaluation of the device's algorithms was conducted.
- The "Non-Clinical Performance Tests (bench testing)" verified the respiration rate and pulse rate range, accuracy, resolution, and signal quality by comparing reported values with "simulated values." This is a standalone assessment.
- The "second series of clinical tests" validated the "pulse rate calculation algorithm of the subject device" using "annotated ECG traces from the AHA arrhythmia database." This is a standalone evaluation of the algorithm's performance against a known ground truth.
7. The Type of Ground Truth Used:
- Clinical Performance Test (First series): The predicate device, the Philips IntelliVue Patient Monitor MP2, served as the ground truth/reference for respiration rate and heart rate.
- Clinical Performance Test (Second series): Expert-annotated ECG traces from the AHA arrhythmia database were used as the ground truth for validating the pulse rate calculation algorithm. This represents a form of expert consensus or established medical standard.
- Non-Clinical Performance Tests: "Simulated values" were used, suggesting a controlled, engineered ground truth for bench testing.
8. The Sample Size for the Training Set:
The document does not provide information about the sample size used for the training set. This summary focuses on the verification and validation of the device, implying that the training and development phases would have occurred prior to this submission.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).