(84 days)
The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need for monitoring the physiological patient parameters SpO2 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with IntelliVue Patient Monitors MP5, MP5T, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRx4841A, is for monitoring, recording, and alarming arterial oxygen saturation and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. It is not intended for home use. The device is not a therapeutic device.
The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for monitoring the physiological patient parameters non-invasive blood pressure and pulse rate wirelessly.
The intended use of the IntelliVue CL NBP Pod when used together with IntelliVue Patient Monitors MP5, MP5T, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRx4841A is for monitoring, recording, and alarming of systolic, diastolic, and mean pressure and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. It is not intended for home use. The device is not a therapeutic device.
The IntelliVue Patient Monitors MP5, MP5T, MP2, X2 are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside of the hospital environment. The MP2, X2, and MP5 monitors are also intended for use during patient transport outside of the hospital environment.
They are not intended for home use. The monitors are only for use on one patient at a time. They are not therapeutic devices.
The IntelliVue Telemetry System Transceiver TRx4841A is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Intended to provide ambulatory and bedside monitoring, recording and alarming of ECG and SpO2 parameters of adult and pediatric patients in transport and hospital environments.
It is intended to be used by trained healthcare personnel. It is not intended for home use. The device is only for use on one patient at a time. It is not for use with infant or neonatal patients.
The new Philips IntelliVue CL SpO2 Pod is a small, battery powered, wrist worn pulse oximeter device for cableless monitoring of patients. It contains Philips FAST-Sp02 (Fourier Artifact Suppression Technology) to provide reliable saturation values under various artifact conditions including motion and low perfusion. It provides continuous operating mode and intermittent operating mode with configurable measurement intervals. Integrated monochrome LCD display shows measured values, measurement signal quality, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable Sp02 sensors.
The new Philips IntelliVue CL NBP Pod is a small, battery powered, non-invasive blood pressure and pulse rate measurement device for cableless monitoring of patients. It uses oscillometric method for measuring NBP. It produces numerics for systolic, diastolic and mean blood pressure values and pulse rate. Integrated monochrome LCD Display shows measured values, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable NBP cuffs.
The Philips IntelliVue MP5, MP5T, MP2, X2 are robust, portable, lightweight, compact in size and modular in design patient monitors with integrated displays and multiple physiological measurements and interfaces to dedicated external measurement devices. With the built-in battery the monitors can also function during transport situations.
With the built-in physiological measurements the monitors MP5, MP2, and X2 provide the following measurement capability: Invasive Blood Pressure, Temperature, CO2, ECG/Respiration, SpO2, and NIBP. The MP5T model provides internal SpO2 and NIBP measurements.
The monitors MP5, MP5T, MP2, X2 can be interfaced to several dedicated external devices to extend the measurement capabilities. The monitors MP5, MP2 and X2 can also be connected to another IntelliVue patient monitor (MP20 to MP90), where they act as multi-measurement modules acquiring measurements for the host monitor. The network interfaces provide the monitors MP5, MP2 and X2 with networking capability via wired or wireless network connections. The monitors MP5, MP5T, MP2, and X2 can also interface via cable or wirelessly via short range radio to the IntelliVue Telemetry Transceiver TRx4841A.
As a result of the current modification, the MP5, MP5T, MP2, X2 patient monitors can be interfaced wirelessly via short range radio to the new CL NBP and SpO2 Pods.
The Philips IntelliVue Telemetry System Transceiver TRx4841A is a small, lightweight, battery powered patient-worn device for monitoring ECG and Sp02. The TRx4841A Transceiver uses transmission through a body (finger tip) method and Philips FAST-Sp02 algorithm to measure SpO2. The TRx4841A Transceiver provides ECG using standard ECG and EASI derived 12-lead monitoring, 6lead monitoring with 2 V-leads and EASI derived 12-lead ECG technology with only 5 leads.
The TRx4841A Transceiver sends patient digitized ECG/SpO2 signals via cable or wirelessly (via SRR) to the IntelliVue Patient Monitors MP5, MP5T, MP2, X2 or wirelessly (via WMTS 1.4 GHz) to the Philips IntelliVue Information Center, which displays ECG waveforms, heart rate, and SpO2 values, detects and analyzes the ECG for cardiac arrhythmias and displays alarm conditions and INOP's. Displays, settings, recordings, and alarms are controlled from the IntelliVue Information Center or the Patient Monitors.
As a result of the current modification, the transceiver TRx4841A can be interfaced wirelessly via short range radio to the new CL NBP and SpO2 Pods. The transceiver TRx4841A sends patient digitalized SpO2/NBP signals from the connected CL NBP and SpO2 Pods wirelessly (via WMTS 1.4 GHz) to the Philips IntelliVue Information Center, which displays the physiological measurement values and indicates alarms.
Here is an analysis of the provided text regarding the acceptance criteria and supporting studies for the Philips IntelliVue CL SpO2 Pod and CL NBP Pod:
Device: Philips IntelliVue CL SpO2 Pod and IntelliVue CL NBP Pod
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance (Summary) |
|---|---|---|
| IntelliVue CL SpO2 Pod | ||
| SpO2 Accuracy | ISO 9919 (recognized consensus standard) | Met performance requirements of ISO 9919 and recommendations of FDA draft guidance. |
| Pulse Rate Accuracy | Within specified measurement range | Validated within specifications, substantial equivalent to predicate device. |
| Averaging of Numerics (SpO2, Pulse Rate, Perfusion Index) | Not explicitly stated but implied to be within specifications. | Verification of averaging for calculated numerics. |
| IntelliVue CL NBP Pod | ||
| Systolic/Diastolic Blood Pressure Accuracy | ANSI/AAMI SP10 (recognized consensus standard) | Met performance requirements of ANSI/AAMI SP10. |
| Pulse Rate Accuracy | Within specified measurement range | Validated within specified measurement range. |
| Overall NBP performance compared to predicate devices | Not explicitly stated as a separate acceptance criterion, but implied. | Produced same results as appropriate predicate devices. |
2. Sample Sizes Used for the Test Set and Data Provenance
- IntelliVue CL SpO2 Pod: A "clinical desaturation study" was performed. The specific number of subjects/samples is not provided in the given text.
- IntelliVue CL NBP Pod: A "clinical study" using the auscultatory reference method was performed. The specific number of subjects/samples is not provided in the given text.
- Data Provenance: The text does not specify the country of origin. Both studies are described as "clinical studies" and "clinical performance validation," which implies prospective data collection, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- IntelliVue CL SpO2 Pod: The text refers to a "clinical desaturation study" to determine SpO2 accuracy. The ground truth (reference SpO2 values) for such studies is typically established using a co-oximeter connected to arterial blood samples analyzed by laboratory personnel. However, the exact number and qualifications of experts involved in establishing this reference are not specified in the provided text.
- IntelliVue CL NBP Pod: The ground truth for blood pressure accuracy was established using the "auscultatory reference method" according to ANSI/AAMI SP10. This method typically involves trained observers (e.g., medical professionals) using a stethoscope and sphygmomanometer. However, the number and specific qualifications of these experts are not provided in the text.
4. Adjudication Method for the Test Set
The text does not provide any information regarding an adjudication method for either the SpO2 or NBP clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed for these devices. The studies described are validation studies against established reference methods and standards, focusing on the device's standalone accuracy rather than human reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, standalone performance studies were conducted. The clinical studies for both the CL SpO2 Pod and CL NBP Pod evaluate the accuracy of the device's measurements (SpO2, pulse rate, blood pressure) against a reference standard. This is a measure of the device's algorithm-only performance.
7. Type of Ground Truth Used
- IntelliVue CL SpO2 Pod: The clinical desaturation study (to determine SpO2 accuracy) implies the use of a co-oximeter as the gold standard for arterial oxygen saturation.
- IntelliVue CL NBP Pod: The clinical study used the auscultatory reference method according to ANSI/AAMI SP10 for blood pressure.
8. Sample Size for the Training Set
The provided text does not mention or describe a training set for these devices. The descriptions focus on performance validation studies (test sets) for their accuracy against established medical standards. This suggests a traditional medical device development approach where algorithms are designed based on known physiological principles and validated against clinical data, rather than being "trained" in the machine learning sense on a distinct training dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, information on how its ground truth was established is not applicable.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).