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510(k) Data Aggregation
(21 days)
The Dideco D732 MICRO 27 Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The fitter is 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 D732 MICRO 27 Ph.I.S.I.O. is sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 7.0 liters/minute. The D732 MICRO 27 Ph.I.S.I.O. is an Adult Arterial Filter with 27 micron filter screen designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 27 microns from the arterial line perfusate. The D732 MICRO 27 Ph.I.S.I.O. is a modified version of the currently marketed D732 MICRO 20. The modification consists of coating all blood contact surfaces with phosphoryicholine additive that improves the blood compatibility of the substrate materials and change of the pleated polyester filter screen pore size from 20 to 27 micron. Other than this change the D 732 MICRO 27 Ph.I.S.I.O. and the D 732 MICRO 20 are identical in design, materials, and manufacturing processes.
This document is a 510(k) summary for the D732 MICRO 27 Ph.I.S.I.O. adult arterial filter. It focuses on demonstrating substantial equivalence to a predicate device and outlining non-clinical and in vitro test results rather than a detailed study design with acceptance criteria tables.
However, based on the provided text, I can extract the following information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:1995 standards for raw materials | "Testing was performed on the D736 MICRO 40 Ph.I.S.I.O. (accelerated aging). The devices were aged up to three years and tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity and ETO residuals. Package integrity testing was also conducted. The results of the testing met established specifications." |
| Structural Integrity | Maintain structural integrity after aging | "The device was aged up to 3 years and tested for structural integrity... The results of these tests met established specifications." |
| Mechanical Integrity | Maintain mechanical integrity after aging | "The device was aged up to 3 years and tested for... mechanical integrity... The results of these tests met established specifications." |
| Blood Side Pressure Drop | Maintain acceptable pressure drop | "The results of these tests met established specifications... the performance characteristic demonstrated by the D732 MICRO 27 Ph.I.S.I.O. in terms of pressure drop... are improved with respect to the D732 unmodified device." |
| Filter Flow Rate Capacity | Maintain specified flow rate capacity | "The device was aged up to 3 years and tested for... filter flow rate capacity... The results of these tests met established specifications." |
| In vitro Hemolysis/Cell Depletion | Minimize hemolysis and cell depletion | "The results of these tests met established specifications... the performance characteristic demonstrated by the D732 MICRO 27 Ph.I.S.I.O. in terms of... hemolysis are improved with respect to the D732 unmodified device." |
| Air Handling Characteristics | Maintain acceptable air handling | "The results of these tests met established specifications... There is no statistically significant difference in the air handling characteristics between the D732 MICRO 27 Ph.1.S.I.O and the D732 unmodified device." |
| Filtration Efficiency | 80% particle removal | "The filtration efficiency of the D 732 MICRO 27 Ph.I.S.I.O. meets the 80% particles removal requirement as per AAMI Standard." |
| Sterility | Sterile device | "Additional testing has demonstrated the effectiveness of production techniques assuring that the adult arterial filters are sterile and nonpyrogenic." |
| Non-pyrogenicity | Non-pyrogenic device | "Additional testing has demonstrated the effectiveness of production techniques assuring that the adult arterial filters are sterile and nonpyrogenic." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated. The document mentions "a complete battery of tests" and that "all tests were performed on sterilized aged devices comparing the D732 MICRO 27 Ph.I.S.I.O. vs. the D732 MICRO 20 non aged unmodified device." This implies multiple units were tested for each characteristic but the exact number is not provided.
- Data Provenance: Not specified. The performing laboratories or country of origin for the data are not mentioned. The document is submitted by an Italian company, but this doesn't confirm where the testing occurred.
- Retrospective or Prospective: These were likely prospective laboratory tests conducted specifically for this 510(k) submission.
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 information is not applicable as the described tests are in vitro and biocompatibility tests, not studies requiring expert interpretation of clinical data or images. The "ground truth" is established by adherence to recognized standards and objective laboratory measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable for these types of laboratory performance and biocompatibility studies. Adjudication methods are typically used in clinical trials or studies involving human expert assessment where there might be disagreements in interpretation.
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 information is not applicable. The device is an arterial filter, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical medical device, an arterial filter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance characteristics and biocompatibility of the device is based on International Standards (ISO 10993-1:1995 and AAMI Standard for filtration efficiency) and FDA Guidance documents ("Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000). The product's performance is compared against predefined specifications derived from these standards and guidance.
8. The sample size for the training set:
- This information is not applicable. The device is a physical medical device that undergoes performance and biocompatibility testing, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons stated in point 8.
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