(53 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™ Hematocrit/Saturation (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.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided document describes a 510(k) submission for a modification to the Terumo CDI™ System 500, a blood parameter monitoring system. The core of this submission is to demonstrate substantial equivalence to a predicate device, specifically focusing on a design change to improve the robustness of the Blood Parameter Module (BPM) Probe Cable-Head against moisture ingress.
Therefore, the acceptance criteria and the study primarily revolve around verifying the effectiveness and safety of this specific design change, rather than proving performance metrics for all blood parameters. The document explicitly states: "This design change did not alter the device indication for use or performance specifications."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance/Verification Outcome |
|---|---|
| The BPM Probe Cable-Head functions as expected even in the presence of high humidity (85% RH) | "The design change was verified to meet predefined acceptance criteria and assure that: The BPM Probe Cable-Head functions as expected even in the presence of high humidity (85% RH)" (Section 4: 510(k) Summary, "Verification Testing on Device Modification") |
| The design change does not introduce new safety risks | "The design change was verified to meet predefined acceptance criteria and assure that: The design change does not introduce new safety risks" |
| The design change is effective over the expected life of the BPM probe cable-head | "The design change was verified to meet predefined acceptance criteria and assure that: The design change is effective over the expected life of the BPM probe cable-head" |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for the verification testing. It only generally refers to "Design control activities identified the requirements for the design change, which drove the design change verification activities."
- Data Provenance: Not specified. There is no mention of country of origin, or whether the study was retrospective or prospective. Given the nature of a design change verification, it would likely be prospective testing conducted in a controlled environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for this specific verification testing. The testing appears to be objective engineering verification rather than a clinical study requiring expert interpretation of results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There is no mention of an adjudication method. This type of method is typically used in clinical trials where there's subjectivity in interpreting results and multiple readers are involved. For engineering verification of moisture ingress and function, such a method would not be applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a blood parameter monitor; it does not involve AI or human interpretation of images or complex data in a way that would necessitate an MRMC study. The verification focuses on the hardware's robustness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a measurement system, not an algorithm-based diagnostic or AI-driven tool. The "standalone performance" here refers to the device's ability to measure parameters, which is the inherent function it performs without human interpretation in the loop. The verification covered the robustness of a particular component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this design modification verification would be objective engineering measurements and functional tests. For example:
- Functional performance: The device successfully provides accurate blood parameter readings after exposure to high humidity (ground truth derived from reference methods for blood gas analysis).
- Safety: Absence of electrical malfunction or other hazards after moisture exposure (ground truth defined by safety standards and direct observation).
- Expected life: The component continues to perform functionally for a defined duration under simulated conditions (ground truth against design durability specifications).
- The document implies that the "predefined acceptance criteria" themselves represent the ground truth for success in these tests.
8. The sample size for the training set:
- This question is not applicable as the device is not an AI/ML model that requires a training set. The "design change" refers to a hardware modification, not a software algorithm that learns from data.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reasons as #8.
§ 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).