(115 days)
The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 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 8 liters per minute.
The device may be used in procedures lasting up to 6 hours in duration.
The Terumo Pall AL6X Arterial Filter performs its functions using two basic forms of technology. As a filtration device, particulates in the blood stream are captured and removed from the blood flow as blood passes through a filter mesh 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 an air-removal device, the Terumo Pall AL6X Arterial Filter is 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 materials that are used in the construction of the Terumo Pall AL6X Arterial Filter include polycarbonate, polyester screen, polypropylene, acrylonitrile-butadiene styrene and X-Coating™.
The Terumo Pall AL6X Arterial Filter demonstrates substantial equivalence to the predicate Terumo AL8X Arterial Filter through a series of in-vitro performance evaluations. The study aimed to show functional equivalence in several key areas.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Filtration Efficiency | Performed; demonstrated functional equivalence to predicate device. |
| Air Removal Efficiency | Performed; demonstrated functional equivalence to predicate device. |
| Hemolytic Effect | Performed; demonstrated functional equivalence to predicate device. |
| Pressure Drop | Performed; demonstrated functional equivalence to predicate device. |
| Tubing Connection Strength | Performed; demonstrated functional equivalence to predicate device. |
| Static Priming Volume | Performed; demonstrated functional equivalence to predicate device. |
| Mechanical Integrity/Leakage | Performed; demonstrated functional equivalence to predicate device. |
| Sterility Assurance Level (SAL) | Validated to provide SAL of 10⁻⁶ (AAMI guidelines). |
| Ethylene Oxide Residues | Will not exceed stated or implied maximum limits. |
| Biocompatibility (X-Coating) | Evaluated in in-vivo animal study; no adverse conditions noted. |
2. Sample Size and Data Provenance
The document describes in-vitro performance evaluations. No information is provided regarding specific "test sets" of patient data, as the study involves device performance testing rather than clinical data analysis. The studies were conducted by Terumo Cardiovascular Systems in conjunction with Pall Medical Corporation. No country of origin for data or retrospective/prospective nature is applicable in the context of these in-vitro tests.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth for these performance evaluations is derived from established engineering test methods and benchmarks against the predicate device, not expert human assessment of medical images or patient outcomes.
4. Adjudication Method
Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, which is not the nature of these in-vitro device performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for this type of device (an arterial filter) and the in-vitro performance testing conducted. These studies typically compare the diagnostic performance of human readers with and without AI assistance for clinical tasks.
6. Standalone Performance
Yes, the studies described are standalone performance evaluations for the device itself. They assess the inherent functional capabilities of the Terumo Pall AL6X Arterial Filter (e.g., filtration efficiency, air removal efficiency) independent of human interaction during its operation.
7. Type of Ground Truth Used
The ground truth used for these in-vitro performance evaluations is based on:
- Engineering specifications and measurements: For metrics like filtration efficiency, pressure drop, static priming volume, and mechanical integrity.
- Established industry standards/guidelines: Such as AAMI guidelines for sterility assurance.
- Comparative data against a known predicate device: Functional equivalence was demonstrated against the Terumo AL8X Arterial Filter across various performance metrics.
- In-vivo animal study results: For biocompatibility of the X-Coating.
8. Sample Size for the Training Set
Not applicable. This document describes the performance evaluation of a physical medical device (an arterial filter), not an AI algorithm requiring a training set of data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no AI algorithm or training set involved in this submission.
§ 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.”