(18 days)
The Terumo® Pall AL20X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 20 microns in size, including gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial line and where the flow rate will not exceed 7 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.
The Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6 Arterial Filter, use the same principles of operation and technology. They perform their functions using two basic forms of technology. As filtration devices, particulates in the blood stream are captured and removed from the blood flow as blood passes through a porous filter material that is contained within the device housing. The filter establishes a physical barrier that entraps particulate matter and prevents it from moving downstream of the arterial filter assembly. As air-removal devices, the Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6X Arterial Filter, are designed so that air is removed from the blood stream as a result of centripetal force. The blood inlet port of the device is positioned on the upper-side axis of the polycarbonate housing, thereby creating a spiral blood flow pattern as blood enters the device. As the blood flows through the device in a spiral motion, centripetal forces cause the air bubbles to migrate towards the top of the housing assembly - where air can subsequently be purged from the circuit.
The provided text describes a 510(k) submission for a medical device, the Terumo® Pall AL20X Arterial Filter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for a novel functionality.
Therefore, the requested information regarding "acceptance criteria" for a study that "proves the device meets the acceptance criteria" in the context of AI/ML device assessment (which often involves performance metrics like sensitivity, specificity, AUC) is not directly applicable to this submission. This 510(k) primarily compares the new device to a predicate device based on in-vitro performance evaluations and design characteristics to argue for substantial equivalence.
However, I can extract the closest equivalent information from the provided text, interpreting "acceptance criteria" as the performance measures used to demonstrate equivalence to the predicate device.
Here's the breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the way a modern AI/ML device might. Instead, it demonstrates performance equivalency to a predicate device through a series of in-vitro tests. The implied "acceptance criterion" is that the performance of the Terumo® Pall AL20X Arterial Filter is not significantly worse than the predicate device (Terumo® Pall AL6X Arterial Filter) for key operating parameters, and for some, it is even improved (e.g., smaller pore size).
Table of Performance Evaluations and Implied Comparison to Predicate:
| Performance Evaluation | Terumo® Pall AL20X Arterial Filter Performance | Implied "Acceptance Criteria" Relative to Predicate (Terumo® Pall AL6X Arterial Filter) |
|---|---|---|
| Filtration Efficiency | Not explicitly detailed, but filter pore size is 20µm | Expected to be at least equivalent, if not superior due to smaller pore size (20µm vs 40µm for predicate) |
| Air Removal Efficiency | Not explicitly detailed | Expected to be equivalent |
| Effects on Cellular Components | Not explicitly detailed | Expected to be equivalent (no adverse effects) |
| Effects on Blood Clotting | Not explicitly detailed | Expected to be equivalent (no adverse effects) |
| Pressure Drop at Various Flow Rates | Not explicitly detailed | Expected to be within acceptable clinical ranges, comparable to predicate |
| Static Priming Volume | Not explicitly detailed | Expected to be equivalent |
| Structural Integrity under Maximum Pressure | Not explicitly detailed | Expected to withstand maximum pressure equivalently to predicate |
| Structural Integrity under Maximum Flow Rate | Not explicitly detailed | Expected to withstand maximum flow rate (7 L/min) equivalently to predicate |
| Packaging Integrity | Not explicitly detailed | Expected to be equivalent |
| Tubing Connection Strength | Not explicitly detailed | Expected to be equivalent |
| Device Holder Compatibility | Not explicitly detailed | Expected to be compatible |
Key Design Differences & Rationale for Equivalence:
- Filter Pore Size: AL20X has 20µm, AL6X (predicate) has 40µm. Smaller pore size is an improvement for micro-emboli removal. "Filter pore size of 20 um to 40 um for arterial line filters is standard to the industry."
- Maximum Flow Rate: AL20X has 7 L/min, AL6X (predicate) has 8 L/min. This difference is deemed "not clinically relevant" because "A blood flow rate of 7 L/min or less is typically used in Cariopulmonary Bypass procedures and most bypass components are only qualified to a maximum flow rate of 7 L/min."
Other Requested Information (Not directly applicable in the context of this 510(k) for an arterial filter, but addressed based on closest interpretation):
Since this is a submission for a physical medical device (arterial filter) and not an AI/ML diagnostic or prognostic tool, many of the requested fields are designed for AI/ML device evaluation and are not present in this document.
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Sample size used for the test set and the data provenance:
- The document mentions "in-vitro performance evaluations," implying lab-based testing. It does not provide specific sample sizes (e.g., number of devices tested for each evaluation).
- Provenance: The tests were conducted by Terumo Cardiovascular Systems ("Terumo Cardiovascular Systems conducted the following in-vitro performance evaluations...").
- Retrospective or Prospective: These would be prospective in-vitro tests performed on manufactured devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an in-vitro device evaluation; ground truth would relate to physical measurements and engineering specifications, not expert interpretation of outputs.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is an in-vitro device evaluation.
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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 not an AI-assisted device requiring human reader interaction.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a standalone physical medical device. The "performance evaluations" are effectively the standalone performance of the device without human interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in-vitro tests, the "ground truth" is based on established engineering and scientific principles, measurement standards for parameters like pore size, flow rate, pressure drop, and material compatibility.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML model requiring a training set. Its design is based on established engineering principles and prior device iterations (predicate).
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.
§ 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.”