FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The 20 u arterial blood filter is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.

AI/ML Overview

Acceptance Criteria and Study for AFFINITY® 20u Arterial Blood Filter

The provided document describes the submission of a "SPECIAL 510(k)" for the AFFINITY® 20u Arterial Blood Filter, which is a modification of an existing device (AFFINITY® 38u Arterial Blood Filter) with a change only in the filter pore size. The review focuses on demonstrating substantial equivalence to predicate devices, specifically the AFFINITY® 38u Arterial Blood Filter and the INTERSEPT® 20 µ Arterial Blood Filter.

No Acceptance Criteria or Device Performance Table Provided:

The provided text does not explicitly state specific acceptance criteria with quantifiable targets for each characteristic (e.g., "Prime volume must be less than X mL"). Instead, it states that the in vitro bench testing demonstrated that the AFFINITY® 20µ Arterial Blood Filter "does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters" when compared to predicate devices. Therefore, a table of acceptance criteria and reported device performance cannot be created from the given information.

The study aimed to demonstrate that the new device, despite a change in a technological characteristic (pore size), does not raise new types of safety or effectiveness questions and that its performance is substantially equivalent to legally marketed predicate devices.

Study Details:

Acceptance Criteria and Reported Device Performance:
As noted above, no specific quantitative acceptance criteria or reported performance values are provided. The general acceptance criterion was "does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters" compared to predicate devices.

The in vitro bench testing included analysis of the following characteristics to demonstrate substantial equivalence:
- I. Physical Characteristics:
  - Prime volume
  - Pressure integrity
- II. Performance Characteristics:
  - Pressure drop
  - Ease of prime
  - Filtration efficiency
  - Microemboli removal
  - Bolus air management
  - Blood trauma
Sample Size used for the test set and the data provenance:
The document does not specify the exact sample size for the test set used in the in vitro bench testing. It only states that "Performance data to assess the effects of these new technological characteristics has been performed." The data provenance is also not specified; however, given it's an in vitro bench test, it would have been conducted in a laboratory setting. It is inherently prospective as it involves new testing of the modified device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study appears to be entirely in vitro bench testing of physical and performance characteristics, not an evaluation requiring expert interpretation or human "ground truth" establishment in the typical clinical sense. The "ground truth" for these tests would be established by validated measurement techniques and comparison against established performance benchmarks of predicate devices.
Adjudication method for the test set:
This information is not applicable as the study involves in vitro bench testing, not an evaluation requiring independent adjudication of clinical findings or expert consensus.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The study described is an in vitro bench testing comparison of a device's physical and performance characteristics to predicate devices. It does not involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm-only performance study was not done. This device is a physical medical device (an arterial blood filter), not an algorithm or AI system.
The type of ground truth used:
The "ground truth" for this in vitro bench testing would be derived from objective measurements obtained through standard scientific methods for each physical and performance characteristic (e.g., precise volume measurements for prime volume, pressure sensors for pressure drop, various measurement techniques for filtration efficiency and microemboli removal). The performance of the predicate devices would serve as the comparative ground for demonstrating substantial equivalence.
The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve machine learning or AI, and therefore does not have a "training set" in the context of data-driven models.
How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" for this physical device.

Summary

Regulation Number and Section

§ 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.”