(172 days)
The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The IBC Gas Cell Component may be substituted for the CDI Gas Cell Component in the construction of Extracorporeal Custom Tubing Packs either by the manufacturer of such packs or by the end user to modify his or her pack as needed.
The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The final geometry of the IEC Gas Cell component is identical to the final geometry of the 3M Gas Cell component, and both are fabricated from the same plastic materials. The functional properties of the Gas Cells are determined by the final assembly geometry and the materials employed in construction, especially the two membrane materials. The final geometry of the IBC and CDI components are identical. Using chemical analysis, electron microscopy and information in the public domain, the membranes were sourced from the same supplier used by 3M. The device employs three photochemical sensors to measure pO2, pCO2, and pH. Additionally, there is a thermo-electronic sensor for the direct measurement of temperature.
The provided text describes a 510(k) summary for the IBC Gas Cell Component, demonstrating its equivalence to the CDI Gas Cell Component for use with the CDI Model 300 Blood Gas Monitoring System. The study primarily focuses on functional equivalence, assembly integrity, toxicity, and sterilization compatibility.
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1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria in a quantitative format as one might expect for a modern regulatory submission. Instead, the acceptance criterion for the functional evaluation appears to be that the IBC Gas Cell component performs identically or shows no significant difference compared to the predicate CDI Gas Cell component. For other evaluations (assembly integrity, toxicity, sterilization), the criterion is generally "no leaks detected," "meet U.S.P. Plastic Class 6," "non-hemolytic," "low bioburden," and "meet FDA recognized standards for ethylene oxide residues."
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Equivalent performance to CDI Gas Cell (predicate device) in CDI Model 300 System. | "The two products were identical relative to performance and function." |
| Measured Parameters: pO2, pCO2, pH must show comparable error to predicate. | Average errors for IBC and CDI cells were comparable (e.g., pO2: IBC 1% Avg Err, CDI -3% Avg Err; pCO2: IBC 1% Avg Err, CDI 3% Avg Err; pH: IBC 0% Avg Err, CDI 0% Avg Err). Graphs show similar correlation to IL data. | |
| Assembly Integrity | No leaks detected after stress tests (temperature, shaking, drop, pressure). | "No leaks were detected" after assembly leak test (temperature, shaking, drop, pressure) and clinical simulation leak test. |
| Clinical Simulation Leak | No cellular (Red) components present on top of the membrane after recirculation. | "No leaks were detected." (straw colored plasma, no cellular components). |
| Sensor Seal Integrity | No leaks detected at 10 P.S.I. after sensor insertion. | "No leaks were detected." |
| Toxicity Testing | Meet U.S.P. Plastic Class 6. | "The samples were found to meet U.S.P. Plastic Class 6." |
| Hemolysis | Non-Hemolytic (no free hemoglobin in plasma). | "The samples were found to be Non-Hemolytic." |
| Bioburden | Low bioburden to assure safety with ETO sterilization. | "Average bioburden of 20 colony forming units per assembly." |
| ETO Residues | Meet FDA recognized standards for ethylene oxide residues. | Specific EO and ECH levels provided (e.g., EO 0.11 ppm, ECH 0.011 ppm), implying compliance. |
| Pyrogenicity | Non-Pyrogenic per USP. | "The samples were found to be Non-Pyrogenic, U.S.P." |
2. Sample Size Used for the Test Set and Data Provenance
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Functional Evaluation:
- Test Set Size: 10 IBC Gas Cell components and 10 CDI Gas Cell components were tested. Each component was subjected to a procedure that yielded 10 different readings for each parameter (pO2, pCO2, pH), resulting in 100 readings per component type for measured parameters. The table of results shows 10 samples (runs) for CDI and 10 samples (runs) for IBC, with averages based on these. For each run, multiple parameters were measured. The report mentions "200 data points for all measured and calculated parameters" which implies 100 for each.
- Data Provenance: Prospective, simulated clinical setting using human blood (for initial priming) and later bovine blood (for clinical simulation leak test, hemolysis). The description doesn't explicitly state the country of origin of the blood, but the context is a US submission (510(k)).
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Assembly Integrity: 60 IBC Gas Cell Components.
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Clinical Simulation Leak Test: The same 60 samples from the Assembly Leak Test.
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Sensor Seal Integrity: 10 samples from the Assembly Leak Test section.
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Toxicity Testing (USP Class 6): Samples of clear plastic housing, elastomer seal, opaque white membrane, and clear membrane. (Number of samples not specified, but typically conducted on material batches).
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Hemolysis: 10 IBC gas cell components and 10 CDI gas cell components.
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Bioburden, ETO Residues, Pyrogenicity: Samples of the device (number not explicitly stated but sufficient for testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Functional Evaluation: The "ground truth" for the blood gas parameters (pO2, pCO2, pH) was established by an Instrumentation Laboratories Model 1420 Blood Gas Analyzer and an Instrumentation Laboratories Model 482 Co-Oximeter. These are reference laboratory instruments, not human experts.
- Other Tests (Integrity, Toxicity, Hemolysis, etc.): Ground truth was established by laboratory testing using established protocols (e.g., visual inspection for leaks, USP standards, GLP's, centrifugation for hemolysis). No human experts are mentioned as establishing ground truth in the sense of consensus reading from images or complex diagnoses.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for functional performance was objective measurements from laboratory instruments. For other tests, it was objective laboratory results or visual inspection against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this was not an MRMC comparative effectiveness study. This study evaluated the performance of a medical device (a gas cell component) in measuring blood gas parameters, not a diagnostic imaging algorithm that would typically involve multiple human readers interpreting cases. The comparison was device-to-device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this study is inherently a "standalone" evaluation of the device component. The IBC Gas Cell Component is a physical component that functions within a larger blood gas monitoring system. Its primary output is the measurement of blood gas parameters. The study directly measures how accurately this component (in conjunction with the monitoring system) determines these parameters compared to a laboratory reference standard. There is no "human-in-the-loop" interaction in the output of the measurements that are being specifically evaluated for the gas cell component itself.
7. The Type of Ground Truth Used
- Functional Evaluation (pO2, pCO2, pH): Objective measurements from reference laboratory instruments (Instrumentation Laboratories Model 1420 Blood Gas Analyzer and Model 482 Co-Oximeter).
- Calculated Parameters ([HCO3], BE, SAT): These were derived from the measured parameters by the CDI Model 300 system's internal programs. The accuracy of these calculations themselves was not the primary focus of the equivalence study, but their errors were reported for general interest.
- Assembly Integrity/Leak Tests: Visual inspection (e.g., for leaks, presence of cellular components).
- Toxicity: Compliance with USP Plastic Class 6 standards (laboratory testing).
- Hemolysis: Visual inspection of plasma fraction after centrifugation (straw colored vs. pink/red).
- Bioburden, ETO Residues, Pyrogenicity: Laboratory analysis per established methods (e.g., C.G. Laboratories standard methods, USP).
8. The Sample Size for the Training Set
Not applicable. This device is a physical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training" in this document refers to calibration of equipment.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).