(29 days)
The AF 620 Ph.I.S.I.O. with 20 micron screen with phosphoryIcholine coating and the AF 640 Ph.I.S.I.O. with 40 micron screen with phosphory choline coating are recommended for use in the arterial line of the extracorporeal nicuti during any procedure that requires cardiopulmonary bypass. The filters, are used to trap and remove gaseous emboli as well as particulate debris that may be 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 AF 620 Ph.1.S.I.O. and 640 Ph.I.S.I.O are sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 6.0 liters/minute. The AF 620 Ph.I.S.I.O. and 640 Ph.I.S.I.O are Arterial Filters with 20 and 40 micron filters screen, respectively, designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris, greater than the pore size, from the arterial line perfusate. The AF 620 Ph.I.S.I.O. and 640 Ph.I.S.I.O are a modified version of the currently marketed D731 and D733 MICRO Ph.I.S.I.O. The modifications consist of: a different port orientation of the blood outlet port in order to improve the ease of use, ergonomics and fluid dynamics properties; change from polyurethane potting to ultrasonic welding for improved overall biocompatibility; the size of the filter housing has been reduced thus the filter net is double pleated rather than single pleated: the pore size of the filter screen for the AF 620 Ph.I.S.I.O. has been reduced from 27 micron to 20 micron with respect to the D731 MICRO Ph.I.S.I.O. for improved filtration efficiency; a and different formulation of phosphorylcholine monomer has been used to improve wettability. As a consequence of these modifications, the labeling has been updated.
The modified device has unchanged intended use, operating principles, manufacturing, control mechanisms, sterilization process and fundamental scientific technology.
The provided document is a 510(k) summary for a medical device (Arterial Filters), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI device performance metrics, expert involvement, and ground truth establishment is not applicable or available in this type of submission.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and effectiveness, which serves as the "acceptance criteria" for this type of medical device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, "acceptance criteria" are implied by the established specifications for various in vitro and non-clinical tests, and "reported device performance" refers to the device meeting these specifications and demonstrating substantial equivalence to the predicate.
| Acceptance Criteria (Implied Specification: Meet established specifications/Demonstrate equivalence) | Reported Device Performance (Summary) |
|---|---|
| Non-Clinical Testing: | |
| Sterility | Met established specifications |
| ETO residuals | Met established specifications |
| Hemolysis | Met established specifications |
| Acute Systemic Toxicity | Met established specifications |
| Mutagenicity/Cytotoxicity | Met established specifications |
| Irritation | Met established specifications |
| Sensitization | Met established specifications |
| Hemocompatibility | Met established specifications |
| In Vitro Testing: | |
| Operating Blood Volume | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
| Structural Integrity Test | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
| Pressure Integrity Test | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
| Pressure Drop | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
| Filter Flow Rate Capacity | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
| In Vitro Hemolysis/Cell Depletion | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
| Filtration Efficiency (AF 620 specifically) | Met established specifications (improved from 27 to 20 micron); demonstrated substantial equivalence to unmodified devices at max blood flow |
| Leaching of the Coating | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
| Handling Characteristics | Met established specifications; demonstrated substantial equivalence to unmodified devices at max blood flow |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or cases in a formal statistical sense for a clinical trial. The testing involved multiple units of the AF 620 Ph.I.S.I.O. and AF 640 Ph.I.S.I.O. arterial filters, as well as the unmodified predicate devices (D731/D733 MICRO Ph.I.S.I.O.) for comparative purposes. The number of individual units tested for each specific test (e.g., how many filters were subjected to a pressure drop test) is not provided.
- Data Provenance: The testing was "carried out for the AF 640 Ph.I.S.I.O. Arterial Filter" and states "For comparative purposes all tests, when applicable, were performed on sterilized aged devices comparing the AF 620/640 Ph.I.S.I.O. arterial filters vs. the unmodified devices operated at same max blood flow." This indicates that the data is from in-house laboratory testing (in vitro and non-clinical), likely conducted by or for Sorin Group Italia. It is prospective in the sense that the tests were designed and executed to evaluate these specific modified devices. No country of origin of the data is explicitly stated beyond Sorin Group Italia being the submitter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This question is not applicable as this is a medical device (arterial filter) and not an AI or imaging device where human experts establish ground truth for image or data interpretation. The "ground truth" here is the physical and biological performance of the device against established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
- Not applicable. This relates to human interpretation of data/images, which is not relevant for this device. The "adjudication" is implicitly done by the test results meeting pre-defined quantitative or qualitative specifications in a laboratory setting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No. This is a medical device, not an AI or imaging device that involves human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
- Laboratory-established specifications and regulatory standards: The "ground truth" for this device is its performance against established engineering specifications (e.g., flow rate capacity, pressure drop, filtration efficiency, structural integrity, sterility, ETO residuals) and biological safety standards (e.g., ISO 10993 for biocompatibility). The claim of substantial equivalence is also a key "ground truth" for these types of submissions, showing that the modified device performs similarly to or better than previously cleared predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
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.”