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The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D735 MICRO 20 and D736 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 2.5 liters/minute. The D735 MICRO 20 and D736 MICRO 40 are Newborn-Infant Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The bypass connector has been eliminated in the modified versions of the D736 predicate devices resulting in enhanced ergonomics. In addition, the maximum blood flow rate has been increased to 2.5 liters/minute, in order to be consistent with the maximum flow rate of the cleared D736 MICRO Ph.I.S.I.O. modified device (K002493).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify exact sample sizes for each in-vitro test. However, it states that "all tests were performed on sterilized aged devices" comparing the D735 MICRO 20 (operated at 2.5 LPM) against its D735 predicate device (operated at 2.0 LPM), and the D736 MICRO 40 (operated at 2.5 LPM) against its D736 predicate device (operated at 2.0 LPM).

The data provenance is retrospective, as the testing was performed on aged devices, and the entire document is a 510(k) submission, which is a premarket notification process based on demonstrating substantial equivalence to a legally marketed predicate device. The country of origin for the submitter is Italy (Dideco S.p.A., Mirandola, MO, Italy).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a medical filter, and its performance is evaluated through objective physical and biological in-vitro tests, not through expert-based assessment of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in the typical sense of a clinical study.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective in-vitro test results against established specifications, not human adjudication of subjective data.

5. 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

Not applicable. This is not a diagnostic device involving human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device. The device itself is a physical filter.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this medical device is based on pre-defined, objective experimental specifications for physical and biocompatibility characteristics, aligned with relevant guidance documents (e.g., "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" and ISO 10993-1:1995). The comparison is against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

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