(240 days)
The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.
The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:
- CDI™ 500 Monitor .
- Arterial and/or Venous Blood Parameter Modules (BPM) .
- CDI™ H/S Probe .
- CDI™ 540 Gas Calibrator and Calibration Gases (A and B) .
- CDI™ 510H Shunt Sensor .
- Shunt Bypass Line .
- CDI™ H/S Cuvette with or without extension tubing .
- Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) .
- . Printer Paper
The CDI™ System 500 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electrooptics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.
The provided text describes a 510(k) summary for the CDI™ Blood Parameter Monitoring System 500, a device for continuous, on-line monitoring of various blood parameters during cardiopulmonary bypass. The submission is for "Modifications to previously cleared system" and aims to demonstrate substantial equivalence to predicate devices K123039 and K972962.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document states that the performance testing was conducted to "verify/validate the changes to the CDI™ System 500". The conclusion section further states that the modified device has "substantially equivalent performance specifications as compared to the predicate device." However, no specific quantitative acceptance criteria or detailed results of device performance metrics (e.g., accuracy, precision for each parameter like pH, pO2, pCO2, etc.) are provided in this summary. The document only broadly mentions "System verification testing in a blood loop to simulate clinical use."
Since specific acceptance criteria and detailed device performance are not explicitly stated in the provided text, the table below will reflect the information that is present:
| Parameter/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall System Performance | Substantially equivalent to previously cleared predicate devices | Substantially equivalent to predicate devices K123039 and K972962 |
| Software Verification and Validation Testing | Successful completion of testing | Performed and verified |
| System Verification Testing | Successful simulation of clinical use in a blood loop | Performed and validated |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "System verification testing in a blood loop to simulate clinical use," but does not specify the number of blood samples, runs, or test conditions.
- Data Provenance: Not explicitly stated, though the testing was described as "in a blood loop," implying an in-vitro or ex-vivo setting rather than live human subjects. This suggests controlled laboratory conditions. The country of origin for the data is not mentioned. It is a retrospective summary of testing performed for the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The testing described is "System verification testing in a blood loop to simulate clinical use." This typically involves comparing the device's measurements against a reference method or standard in the blood loop, not against expert interpretation of data generated by the device itself. Therefore, ground truth would likely be established by precise laboratory reference measurements rather than expert consensus on device output.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading) to resolve discrepancies. This study focuses on the technical performance of a monitoring device against reference values in a lab setting, where disagreement on "ground truth" (e.g., from a calibrated reference sensor) is not resolved by adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study is not relevant to this device. This device is a blood parameter monitoring system, not an AI-assisted diagnostic imaging or interpretation tool that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Since this is a monitoring device, its primary function is standalone performance (i.e., the accuracy of its measurements). The "System verification testing" would have assessed the standalone performance of the device in measuring blood parameters in a simulated environment. While not explicitly called "standalone performance," this is the nature of the testing described for such a device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Based on the description "System verification testing in a blood loop to simulate clinical use," the ground truth would most likely be established by reference laboratory methods or highly accurate and calibrated reference sensors/analyzers used to measure the blood parameters (pH, pO2, pCO2, K+, SO2, Hct, Hgb, Temperature) in the blood loop. This ensures an objective and reliable comparison against the device's readings.
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The sample size for the training set:
- Not applicable/Not mentioned. This is a monitoring device based on electro-optics modules, fluorescence chemistry, and optical reflectance technology, incorporating a microprocessor for calculations. It's not described as a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense (i.e., for supervised learning). While its internal algorithms and calibrations are developed, this typically involves engineering and validation against physical and chemical principles and reference standards, not a "training set" of patient data.
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How the ground truth for the training set was established:
- Not applicable for the reason given in point 7. For algorithms within such a device, "ground truth" during development would be established through meticulous engineering, physical modeling, chemical principles, and calibration against known standards and reference measurements.
§ 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).