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510(k) Data Aggregation
(172 days)
The IBC Quick Cell component was developed for use with the CDI Model 400 Blood Gas Monitoring System manufactured by 3M. The purpose of this report is to demonstrate the equivalence of the IBC Quick Cell component, as a substitute for the CDI Kwik Cell component.
The IBC Quick Cell component was developed for use with the CDI Model 400 Blood Gas Monitoring System manufactured by 3M. The final geometry of the IBC Quick Cell component is identical to the final geometry of the 3M Kwik Cell component, and both are fabricated from the same plastic materials. Performance of the IBC Quick Cell component within the CDI Model 400 Blood Gas Monitoring System is identical to the CDI Kwik Cell component. The materials were evaluated for toxicity and sterilization compatability requirements as well as for function.
The CDI Model 400 Blood Gas Monitoring System er ploys three photochemical sensors to measure pO3, pCO2 and pH. Additionally, there is a thermo-electronic sensor for the direct measurement of temperature. The Electronics also contain calculation programs which use the measured parameters to determine O2 Saturation (Venous side only) and Base Excess/[HCO3] (Arterial side only). To complete the necessary calculations for these approximations, the Hemoglobin content is also required. This value is internally set at a Hematocrit of 25%. This value is corrected by the user during the initial and any subsequent on line recalibrations.
The functional properties of the Quick Cells are determined by the final assembly geometry and the materials employed in construction, especially the membrane material. The final geometry of the IBC and CDI components are identical. Using chemical analysis, electron microscopy and information in the public domain, the membrane was sourced from the same supplier used by 3M.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the IBC Quick Cell Component:
IBC Quick Cell Component Acceptance Criteria and Study Analysis
The document details a study conducted to demonstrate the equivalence of the IBC Quick Cell component to the CDI Kwik Cell component, for use with the CDI Model 400 Blood Gas Monitoring System.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria for functional performance (e.g., pH difference < X), but rather implicitly defines acceptance as being "identical to" or "comparable to" the predicate CDI Kwik Cell component. For other criteria, specific qualitative outcomes are stated.
| Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance (IBC Quick Cell) |
|---|---|---|
| Functional Evaluation | Performance identical/comparable to CDI Kwik Cell component for measured parameters (pO2, pCO2, pH, O2 Saturation, Base Excess/[HCO3]), especially after on-line recalibration. | - pO2, pCO2, pH: Comparably accurate to CDI flow through cells. Average error for 100 data points (across 10 runs) was 0 for pO2, pCO2, pH. (Graphs 1-6 show strong correlation to IL data, similar to CDI).- O2 Saturation: Performed comparably to CDI cells. (Note: Acknowledged as less accurate than IL Co-Oximeter, but comparable to CDI's performance).- Base Excess/[HCO3]: Calculated values, but functionally equivalent to CDI given pH, pCO2 comparability. |
| Assembly Integrity | No leaks detected after various stress tests (sterilization, temperature variations, shock, pressurization). | - Assembly Leak Test: No leaks detected after sterilization, temperature variations (4°C, 25°C, 60°C), paint mixer shake, 15-foot drops, and 10 P.S.I. pressurization underwater.- Clinical Simulation Leak Test: No leaks detected after 6 hours recirculation in a blood circuit at varying temperatures and flow rates. Membrane showed plasma but no cellular components. |
| Sensor Seal Integrity | No leaks detected after sensors inserted and pressurized. | No leaks were detected after membranes were removed, used sensors inserted, and pressurized at 10 P.S.I. underwater. |
| Toxicity Testing | - Meet U.S.P. Plastic Class 6.- Non-Hemolytic. | - U.S.P. Plastic Class 6: Samples (housing, elastomer, membrane) were found to meet U.S.P. Plastic Class 6.- Hemolysis: Found to be Non-Hemolytic after 6 hours recirculation of bovine blood at 37°C, with a protocol designed to be five times more stringent than typical clinical exposure. |
| Bioburden | Low bioburden to ensure adequate safety margin for sterilization. | Average bioburden of 20 colony forming units per assembly. (Deemed low and safe). |
| Sterilization Efficacy | Effective sterilization, with ethylene oxide residues meeting FDA recognized standards, and non-pyrogenic. | - Ethylene Oxide Residues: Met FDA recognized standards after 14-day aeration.- Pyrogenicity: Found to be Non-Pyrogenic per United States Pharmacopeia. |
| Material Equivalence | Final geometry identical to 3M Kwik Cell component; fabricated from the same plastic materials; membrane sourced from the same supplier as 3M. | - Geometry: Final geometry is identical to 3M Kwik Cell component.- Plastic Materials: Fabricated from the same plastic materials.- Membrane: Sourced from the same supplier used by 3M, confirmed by chemical analysis, electron microscopy, and public domain information. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Functional Test Set): The functional evaluation involved "ten runs" where "five pairs of cells" (one IBC, one CDI) were tested from both manufacturers. Each run involved approximately ten different readings for each parameter (pO2, pCO2, pH). This suggests a total of 50 IBC Quick Cells and 50 CDI Kwik Cells were used. For each cell, approximately 10 data points were collected.
- Data Provenance: The document does not explicitly state the country of origin for the data. However, the study was conducted by "International Biophysics Corporation" in Austin, Texas, USA, for a device to be used with a 3M system. All testing appears to be prospective experimental testing in a controlled laboratory setting, simulating clinical use with human and bovine blood, rather than retrospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Ground Truth Establishment: The ground truth for the functional performance evaluation was established using laboratory instrumentation:
- Instrumentation Laboratories Model 1420 Blood Gas Analyzer
- Instrumentation Laboratories Model 482 Co-Oximeter
- Number and Qualifications of Experts: There were no human experts used to establish ground truth in the functional test. The ground truth was based on readings from established, calibrated laboratory reference instruments. The CDI Model 400 Blood Gas Monitoring System (with either IBC or CDI cells) was then compared against these reference instruments.
4. Adjudication Method for the Test Set
- Adjudication Method: None. As the ground truth was established by laboratory reference instruments, there was no need for human expert adjudication. The comparison was quantitative between the device readings and the reference instrument readings.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a medical device (a blood gas flow-through connector) directly, not on the interpretation of medical images or data by human readers, with or without AI assistance. Therefore, there is no effect size reported for human reader improvement with AI.
6. Standalone Performance Study
- Standalone Performance: Yes. The study primarily focuses on the standalone performance of the IBC Quick Cell component within the CDI Model 400 Blood Gas Monitoring System. The reported performance metrics (error, % error) derived from comparing the system's readings (with either IBC or CDI cells) against independent reference laboratory instruments (IL Blood Gas Analyzer, IL Co-Oximeter) demonstrate the algorithm's (or, in this case, the device's) inherent performance capabilities without human intervention for interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for functional evaluation was data from established, calibrated laboratory reference instruments (Instrumentation Laboratories Model 1420 Blood Gas Analyzer and Model 482 Co-Oximeter). For integrity, toxicity, and sterilization criteria, the ground truth was based on adherence to established standards and tests (e.g., U.S.P. Plastic Class 6, Non-Hemolytic, Non-Pyrogenic, FDA recognized standards for EO residues, C.G. Laboratories standard methods for bioburden).
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not describe a "training set" in the context of an AI/ML algorithm. The study is a direct comparison and validation of a medical device component against a predicate device and established technical/biological standards. There is no information about a training set as would be used in machine learning. The "training" for the device would be its engineering design and manufacturing processes, which are not quantified as a sample size.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The product development would have relied on engineering principles, material science, and testing against design specifications, but this is not characterized as "ground truth establishment for a training set."
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