(125 days)
The CDI OneView Monitoring System is a patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration:
·Potential of Hydrogen (pH)
·Partial Pressure of Carbon Dioxide (pCO2)
·Partial Pressure of Oxygen (pO2)
·Potassium Ion (K+)
·Oxygen Saturation (SO2)
·Hematocrit (HCT)
·Hemoglobin (Hgb)
·Blood Flow Rate (Q)
·Cardiac Index (CI)
·Base Excess (BE)
· Bicarbonate (HCO3- )
·Oxygen Consumption (VO2)
·Indexed Oxygen Consumption (VO2i)
·Oxygen Delivery (DO2)
·Indexed Oxygen Delivery (DO2i)
· Cerebral Regional Oxygen Saturation (rSO2)
·Oxygen Extraction Ratio (O2ER)
· Body Surface Area (BSA)
·Shunt Sensor Temperature
The CDI OneView Monitoring System is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:
- . Core: Core Processing Unit, all other elements connect to the Core
- Display: Touchscreen display with cable ●
- . HSAT Probe: Hematocrit/Saturation probe with cable, interfaces with disposable Cuvette(s)
- BPM Probe: Blood Parameter Module with cable, interfaces with disposable . Shunt Sensor
- Calibrator: Gas calibrator for BPM/Shunt Sensor with cable, interfaces with disposable gas bottles
- Flow Module & Sensor: Flow sensor connected to an external interface ● module with cable.
- . HLM External Device Module: Heart Lung Machine (HLM) interfacing module and cable
- DMS External Device Module: Data output for data management system ● (DMS) interfacing module and cable
- rSO2 External Device Module: Cerebral Oximetry device interfacing module ● and cable
- . Mounting accessories: Different mounting features are used to securely mount elements of the system on an HLM pole during a cardiopulmonary bypass (CPB) case.
- Disposable accessories: The CDI OneView Monitoring System hardware ● connects to disposable accessories which are in-line with the extracorporeal circuit. The BPM probe is attached to Shunt Sensors, the HSAT probe is attached to Cuvette(s) during a CPB case for blood parameters measurement during monitoring. Disposable Gas Bottles (Gas 1 & Gas 2) are used with the Calibrator.
The CDI OneView Monitoring System uses the following measurement technologies:
- Optical fluorescence technology to measure partial pressure of oxygen and . carbon dioxide, pH and potassium ion concentration.
- . Optical reflectance technology to measure oxygen saturation, hematocrit, and hemoglobin within the blood.
- Thermistor (resistive) sensing technology to measure blood temperature. ●
- Non-invasive acoustical sensing technology to measure blood flowrate. ●
The CDI OneView Monitoring System measures blood parameters in real time by utilizing a microprocessor-based core, electro-optics modules (i.e., BPM and H/S probe), flow probe (includes flow module and flow sensor), fluorescence chemistry technology, optical reflectance technology and non-invasive acoustical sensing technology. The electro-optics modules connect the core to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. The flow module connects the core to the flow sensor that use clamp-on mechanism to fit around tubing of the extracorporeal circuit. Light is emitted from the modules, optical responses from the blood and the Ultrasonic/acoustical generated signal measurements via the sensor(s) are measured by the core. The blood parameters are measured or calculated by the CDI OneView Processing Core in real time and displayed to the user via a Touchscreen Display.
The provided text is a 510(k) summary for the Terumo CDI OneView Monitoring System. It outlines the device, its intended use, a comparison to a predicate device, and performance data required for substantial equivalence.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of quantitative acceptance criteria with corresponding device performance for each measured parameter (e.g., specific accuracy ranges for pH, pCO2, pO2). Instead, it relies on general statements about design verification and validation.
However, the "Design Verification and Validation Testing" section states:
- "Design verification testing was conducted and demonstrates that the CDI OneView Monitoring System performs pursuant to the defined design input requirements for the subject device."
- "Design validation, including simulated use testing, was conducted and demonstrates that the CDI OneView Monitoring System meets the defined design input requirements for the subject device."
This implies that there were "defined design input requirements" which served as acceptance criteria, and the device met them. The specific numerical values or ranges for these criteria are not provided in this summary. The "Performance Data" section primarily focuses on:
- Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
- Software Verification and Validation Testing: Successfully completed, with the software considered a "moderate" level of concern.
- Design Verification and Validation Testing: Performed as described above.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on specific sample sizes for test sets used for measuring the accuracy or performance of the individual blood parameters. Given that clinical studies and animal studies were not required or included, the "test set" would likely refer to engineering and simulated use testing.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective clinical data, because clinical studies were not performed. The testing appears to be primarily laboratory-based and simulated use testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as there were no clinical studies mentioned that would typically involve experts establishing ground truth for patient outcomes or diagnostic accuracy. For engineering and simulated use testing, "ground truth" would likely be established by reference instruments or calibrated standards.
4. Adjudication Method for the Test Set
This information is not provided as there were no clinical studies or multi-reader scenarios described that would necessitate an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the CDI OneView Monitoring System to the predicate device and is not included as part of this premarket notification." Therefore, there is no information on human reader improvement with or without AI assistance as this device is a monitoring system and not primarily an AI-driven image interpretation or diagnostic aid tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a "monitoring system" that "displays and outputs information to provide continuous, in-line monitoring of various patient parameters." It is not presented as an AI algorithm for diagnosis or interpretation that would have standalone performance measured against human-in-the-loop performance. Its primary function is to measure and display physiological parameters, which is inherently a "standalone" algorithmic function in that the measurements are provided by the device itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given the nature of the device (a blood parameter monitoring system) and the absence of clinical studies, the "ground truth" for verifying the accuracy of the measured parameters (pH, pCO2, pO2, K+, SO2, HCT, Hgb, Blood Flowrate) would implicitly be based on calibrated reference standards and/or laboratory reference methods for these specific physiological measurements during design verification and validation testing. The text does not specify which exact methods were used, but for such devices, it's standard practice to compare the device's readings to highly accurate laboratory analyzers or calibrated simulation fluids.
8. The Sample Size for the Training Set
This information is not applicable/not provided in the context of machine learning training data. The device is a measurement and monitoring system that utilizes "optical fluorescence technology," "optical reflectance technology," "Thermistor (resistive) sensing technology," and "Non-invasive acoustical sensing technology." While these technologies involve algorithms for signal processing and parameter calculation, the document does not describe the use of machine learning models that would require a "training set" in the typical sense of AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as #8. If any internal algorithms were developed for parameter calculation, their "ground truth" (or basis) would likely stem from established physiological principles, known optical/acoustical properties, and extensive calibration using reference materials, rather than a "training set" with expert-labeled ground truth like in AI/ML applications.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).