(246 days)
The Terumo Pall AL3X Pediatric 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 3 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.
The Terumo Pall AL3X Pediatric 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 AL3X Pediatric 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. Because 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 be manually purged from the circuit.
The provided text describes a 510(k) premarket notification for a medical device, the Terumo Pall AL3X Pediatric Arterial Filter, asserting its substantial equivalence to predicate devices. The information provided is primarily focused on demonstrating this substantial equivalence through performance evaluations and comparisons.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it lists performance evaluations and implies that meeting the performance of the predicate device (Terumo Capiox® AF02X Arterial Filter) is the acceptance criterion for substantial equivalence. The reported device performance is presented as being "functional equivalence" to the predicate.
| Performance Evaluation Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Filtration Efficiency | Functionally equivalent to Terumo Capiox® AF02X Arterial Filter | Demonstrated functional equivalence |
| Air Removal Efficiency | Functionally equivalent to Terumo Capiox® AF02X Arterial Filter | Demonstrated functional equivalence |
| Hemolytic Effect | Functionally equivalent to Terumo Capiox® AF02X Arterial Filter | Demonstrated functional equivalence |
| Pressure Drop | Functionally equivalent to Terumo Capiox® AF02X Arterial Filter | Demonstrated functional equivalence |
| Tubing Connection Strength | Functionally equivalent to Terumo Capiox® AF02X Arterial Filter | Demonstrated functional equivalence |
| Static Priming Volume | Functionally equivalent to Terumo Capiox® AF02X Arterial Filter | Demonstrated functional equivalence |
| Mechanical Integrity/Leakage | Functionally equivalent to Terumo Capiox® AF02X Arterial Filter | Demonstrated functional equivalence |
| Sterility Assurance Level | 10⁻⁶ (Validated in accordance with AAMI guidelines) | Will be validated to provide SAL of 10⁻⁶ |
| Ethylene Oxide Residues | Not to exceed stated/implied maximum residue limits | Will not exceed stated/implied maximum residue limits |
| Biocompatibility | Equivalent to predicate (Terumo Pall AL8X) | Demonstrated equivalence (referenced Terumo Pall AL8X) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly specify the sample sizes (e.g., number of devices tested) for the in-vitro performance evaluations. It simply states that "the following in-vitro performance evaluations" were conducted.
The data provenance is described as:
- Country of Origin: Not explicitly stated, but the submission is from Terumo Cardiovascular Systems Corporation in Elkton, MD, USA. It's likely the tests were conducted in the US, but this is not confirmed.
- Retrospective or Prospective: The performance evaluations were conducted to demonstrate functional equivalence, suggesting they were specifically performed for this 510(k) submission, making them prospective with respect to the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the text. The evaluations are described as "in-vitro performance evaluations" conducted by "Terumo Cardiovascular Systems, in conjunction with Pall Medical Corporation," implying laboratory testing rather than expert-derived ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the evaluations are in-vitro performance tests, not subjective assessments requiring adjudication.
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 tool, and therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is an arterial filter (a mechanical device), not an algorithm or AI system. Its performance is evaluated in-vitro as a standalone device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the in-vitro performance evaluations, the "ground truth" implicitly refers to the established functional performance of the predicate device (Terumo Capiox® AF02X Arterial Filter). The new device's performance is compared against the predicate's known performance characteristics.
For the in-vivo animal study mentioned for the X-Coating™ material, "No adverse conditions were noted" serves as the outcome, but the specific ground truth methodology (e.g., histological analysis, clinical observation) is not detailed.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as above.
§ 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.”