(197 days)
The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.
The proposed gas filter and the Gish filter are each made of materials that are commonly used in cardiopulmonary bypass devices and circuits. The Gish filter is made of ABS, and Versapor (Acrylic); the proposed devices are made of hydrophobic laminated glass media, Versapor (Acrylic) and polypropylene.
Here's an analysis of the provided 510(k) submission for the Gas Filter, focusing on acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Filtration efficiency (0.3 µm particles) | 99.98% efficiency (certified by original manufacturer) |
| Sterility Assurance Level (SAL) | 10⁻⁶ (validated per AAMI guidelines) |
| Ethylene Oxide Residuals | Will not exceed maximum residue limits (21 CFR Part 821) |
| Expiration Dating | Controlled by shortest expiry component or 2 years |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" in the context of typical AI/ML device testing. Instead, it relies on:
- Manufacturer Certification for Filtration Efficiency: The 99.98% efficiency for 0.3 µm particles is stated to be a "certification from original manufacturer." This implies no new testing was performed for this 510(k) submission. Therefore, details on sample size, "test set," or data provenance (country of origin, retrospective/prospective) are not applicable or provided in this document directly related to the filtration efficiency claim. It's likely based on the predicate device's performance data.
- Validation for Sterility and EO Residuals: These are standard regulatory tests. While they involve samples, the specific 'test set' sample sizes and data provenance are not detailed in this summary. These would typically be part of a separate validation report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not describe the use of experts to establish a "ground truth" for a test set, as this is a mechanical filtration device, not an AI/ML diagnostic system. The performance claims are based on direct physical measurements or established manufacturing certifications.
4. Adjudication Method for the Test Set
Not applicable, as there's no "ground truth" established by experts in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or described. This type of study is typically relevant for interpretative AI/ML devices where human reader performance is a key metric. This device is a passive mechanical filter.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithmic performance study was conducted. This device is not an algorithm, but a physical component. The "performance" refers to its mechanical capabilities.
7. Type of Ground Truth Used
The 'ground truth' for the performance metrics is:
- Filtration Efficiency: Manufacturer certification, which would have been based on established standardized test methods using calibrated particle counters and known particle sizes (e.g., using a test aerosol).
- Sterility: Achieved through validated sterilization cycles (e.g., bioburden testing, sterility testing after terminal sterilization), adhering to AAMI guidelines.
- Ethylene Oxide Residuals: Measured through analytical chemistry methods to ensure levels are below regulatory limits.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
(a)
Identification. A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.(b)
Classification. Class II (performance standards).