(13 days)
The Dideco D731 MICRO 20 with 20 micron screen and the Dideco D733 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 intrough the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
The D731 MICRO 20 and D733 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minutes. The D731 MICRO 20 and D733 MICRO 40 are Pediatric 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 maximum blood flow rate has been increased to 5.0 liters/minute.
The provided document describes the Dideco D731 MICRO 20 and D733 MICRO 40 Pediatric Arterial Filters. Based on the information, here's an analysis of the acceptance criteria and the study performed:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it states that "The results of the testing met established specifications" and "The results of these tests met established specifications." The reported device performance is described as comparable or substantially equivalent to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met established specifications; equivalent to predicate devices. |
| Hemolysis | Met established specifications. |
| Cytotoxicity | Met established specifications. |
| In Vitro Studies:** | |
| Structure Integrity | Met established specifications; comparable to predicate devices. |
| Mechanical Integrity | Met established specifications; comparable to predicate devices. |
| Blood Side Pressure Drop | Met established specifications; comparable to predicate devices. |
| Filter Flow Rate Capacity | Met established specifications; comparable to predicate devices. |
| In vitro Hemolysis/Cell Depletion | Met established specifications; comparable to predicate devices. |
| Filtration Efficiency | Met established specifications; comparable to predicate devices. |
| Air Handling Characteristics | Met established specifications; comparable to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide a specific sample size for the "in vitro test results." It mentions that "Testing was performed on the D731 MICRO 20 and of the D733 MICRO 40 (accelerated aging)" and that "all tests were performed on sterilized aged devices." The provenance of the data is not explicitly stated, but the submission is from Dideco S.p.A. in Italy, suggesting the primary data generation might have occurred there. The testing described is prospective, as it involves evaluating the new devices against established protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable. The study is an in vitro and biocompatibility assessment of a physical medical device (arterial filter), not an AI or diagnostic device that requires expert ground truth establishment for patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable since the study is not based on human judgment or interpretation of data needing adjudication. Performance is assessed through objective laboratory measurements.
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
This is not applicable. The device is an arterial filter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is based on pre-established specifications and validated laboratory test methods for physical and mechanical properties (e.g., structural integrity, flow rates, filtration efficiency) and ISO 10993 standards for biocompatibility. The new device's performance is then compared to these specifications and to the predicate devices.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned in point 8.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”