(28 days)
The AF 840 Ph.I.S.I.O. Arterial Filter with 40 micron screen with phosphorylcholine coating is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filter is effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.
The AF 840 Ph.I.S.I.O. is sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 8.0 liters/minute. The AF 840 Ph.I.S.I.O. is an Arterial Filter with 40 micron filters screen 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 840 Ph.I.S.I.O. is a modified version of the currently marketed D734 MICRO 40 Ph.I.S.I.O.
This document describes the premarket notification (510(k)) for the Sorin AF 840 Ph.I.S.I.O. Arterial Filter. It is a modified version of an existing device, and the submission aims to demonstrate substantial equivalence to the predicate device (D734 MICRO 40 Ph.I.S.I.O. Adult Arterial Filter). The information provided is for a medical device and not an AI/algorithm-based device, so some of the requested categories (e.g., sample size for training set, number of experts for ground truth establishment, MRMC study) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Established Specifications) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Met established specifications (ISO 10993) | "The results of the testing met established specifications." |
| Sterility | Met established specifications | "The results of the testing met established specifications." |
| Pyrogenicity | Met established specifications | "The results of the testing met established specifications." |
| ETO residuals | Met established specifications | "The results of the testing met established specifications." |
| Hemolysis | Met established specifications | "The results of the testing met established specifications." |
| Acute Systemic Toxicity | Met established specifications | "The results of the testing met established specifications." |
| Mutagenicity | Met established specifications | "The results of the testing met established specifications." |
| Cytotoxicity | Met established specifications | "The results of the testing met established specifications." |
| Irritation | Met established specifications | "The results of the testing met established specifications." |
| Sensitization | Met established specifications | "The results of the testing met established specifications." |
| Haemocompatibility | Met established specifications | "The results of the testing met established specifications." |
| Package Integrity | Met established specifications | "The results of the testing met established specifications." |
| Operating Blood Volume | Met established specifications | "The results of these tests met established specifications." |
| Structural Integrity Test | Met established specifications | "The results of these tests met established specifications." |
| Pressure Integrity Test | Met established specifications | "The results of these tests met established specifications." |
| Pressure Drop | Met established specifications | "The results of these tests met established specifications." |
| Filter Flow Rate Capacity | Met established specifications | "The results of these tests met established specifications." |
| In vitro Hemolysis/Cell Depletion | Met established specifications | "The results of these tests met established specifications." |
| Filtration Efficiency | Met established specifications | "The results of these tests met established specifications." |
| Leaching of Coating | Met established specifications | "The results of these tests met established specifications." |
| Air Handling Characteristics | Met established specifications | "The results of these tests met established specifications." |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a non-clinical and in-vitro testing battery designed to demonstrate substantial equivalence to a predicate device and compliance with safety and effectiveness requirements, as per the "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" dated November 29, 2000.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of devices or samples used for each test. It refers to "a complete battery of tests" and "all tests, when applicable."
- Data Provenance: The tests were performed in-vitro, which means in a laboratory setting. The country of origin of the data is not explicitly stated, but the submitter is Sorin Group Italia, suggesting the tests were likely conducted in Italy or a contracted laboratory. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate equivalence of the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This is not applicable as this is a medical device and not an AI/algorithm-based device requiring expert ground truth for classification or diagnosis. The "ground truth" for physical device performance is established by the specifications defined in relevant ISO standards and FDA guidance documents.
4. Adjudication Method for the Test Set
- Not applicable for physical device testing. The results are based on measurement of physical and chemical properties and comparison against predefined specifications.
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 a physical medical device, not an AI/algorithm.
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 an AI/algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the performance tests consisted of established specifications derived from:
- Requirements of ISO 10993 for biocompatibility.
- FDA May 1st, 1995 Memorandum on ISO 10993.
- "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000, for in-vitro functional parameters.
- The performance of the unmodified predicate device (D734 MICRO 40 Ph.I.S.I.O. Adult Arterial Filter) was also used for comparative purposes to establish substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/algorithm that requires a training set. The device design and modifications are based on engineering principles and prior device knowledge (predicate device).
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.”