(7 days)
The Dideco D731 MICRO 20 Ph.I.S.I.O., with 20 micron screen with phosphorylcholine coating and the Dideco D733 MICRO 40 Ph.I.S.I.O., with 40 micron screen with phosphorylcholine coating 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 D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are sterile, non-pyrogenic disposable filters for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minute. The D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. 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 D731 MICRO 20 Ph.J.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are a modified version of the currently marketed D731/D733 MICRO. The modification consists of coating all blood contact surfaces with phosphoryIcholine additive that improves the blood compatibility of the substrate materials. Other than this change the D 731/D733 MICRÓ Ph.I.S.I.O. and the D 731/D733 MICRO are identical in design, materials, and manufacturing processes.
The provided document is a 510(k) summary for a medical device modification, specifically for the D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Pediatric Arterial Filters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against specific acceptance criteria.
Therefore, the requested information categories regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are largely not applicable or explicitly detailed in this type of regulatory submission.
Here's an breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. Table of acceptance criteria and reported device performance:
This document does not provide a table of acceptance criteria with numerical targets. Instead, it states that "The results of the testing met established specifications" for various tests. The performance is reported in terms of "comparable" or "substantially equivalent" to the unmodified predicate devices.
| Acceptance Criterion | Reported Device Performance (D731/D733 MICRO Ph.I.S.I.O.) |
|---|---|
| Biocompatibility: | |
| Hemolysis | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Cytotoxicity | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Irritation | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Acute Systemic Toxicity | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Mutagenicity | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Sterility | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Pyrogenicity | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| ETO residuals | Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Material/Product Integrity: | |
| Package integrity | Met established specifications (conducted on D733 MICRO Ph.I.S.I.O., applicable to both) |
| Structural integrity | Met established specifications (compared to D731/D733 unmodified devices) |
| Mechanical integrity | Met established specifications (compared to D731/D733 unmodified devices) |
| Pressure drop | Met established specifications (compared to D731/D733 unmodified devices) |
| Filter flow rate capacity | Met established specifications (compared to D731/D733 unmodified devices) |
| In vitro hemolysis/cell depletion | Met established specifications (compared to D731/D733 unmodified devices) |
| Filtration efficiency | Not affected by modification; applies from D731/D733 unmodified devices |
| Air handling characteristics | Not affected by modification; applies from D731/D733 unmodified devices |
| Overall performance | Substantially equivalent to unmodified devices; comparable characteristics |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a numerical count of devices tested. The document mentions "A complete battery of tests" and "Tests were performed on sterilized aged devices comparing the D731 MICRO 20 Ph.I.S.I.O. vs. the D733 non aged unmodified device and D731 MICRO 40 Ph.I.S.I.O vs. D733 non aged unmodified device". The testing for biocompatibility was performed on the
D733 MICRO Ph.I.S.I.O. (accelerated aging)and the data was considered applicable toD731 MICRO 20 Ph.I.S.I.O.There's no specific "test set" size quantified for each parameter. - Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a regulatory submission, so the data would have been generated internally by the manufacturer or by a contracted lab. It's laboratory-based testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" in this context is based on objective, standardized laboratory measurements against established specifications for device performance, not expert human interpretation (like in imaging studies).
4. Adjudication method for the test set:
- Not applicable. See point 3. Testing involves objective measurements, not human adjudication.
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 document describes a medical device (arterial filter) for mechanical function and biocompatibility, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and "human readers" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. See point 5. This is not an algorithm.
7. The type of ground truth used:
- Objective Laboratory Specifications and Predicate Device Performance: The "ground truth" for the test results is adherence to pre-established scientific/engineering specifications (e.g., ISO 10993 standards for biocompatibility) and performance comparability to the unmodified predicate devices.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. See 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.”