(44 days)
The 40 Micron Transfusion Filter is indicated for removal of microaggregate particles from whole blood and red blood cells and for transfusion of platelets.
Baxter is currently marketing a 40 Micron Transfusion Filter indicated for the removal of microaggregates from whole blood and red blood cells and for the transfusion of platelets. The filter consists of a fiber pad supported by a single layer screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. Fibers which comprise approximately 50% of the current filter pad are being discontinued by the supplier. These fibers are being replaced with fibers from another supplier which differ in size and material formulation.
The provided text describes a 510(k) premarket notification for a modified 40 Micron Transfusion Filter. The submission focuses on a change in the fiber composition of the filter pad from the predicate device and a change in sterilization method from ETO to gamma.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with numerical targets. Instead, the submission states that the modified device "meets or exceeds all functional requirements." The functional performance studies cover various aspects, and the reported outcome is that the device is suitable for its intended use.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Biocompatibility | Biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. Materials found to be acceptable for their intended use. |
| Functional Performance | Filter Prime Time: Data generated and performance indicates suitability. |
| Flow Rate: Data generated and performance indicates suitability. | |
| Filter Capacity: Data generated and performance indicates suitability. | |
| Filter Integrity (% change in hemolysis): Data generated and performance indicates suitability. | |
| Filtration Efficiency (% microaggregate removal): Data generated and performance indicates suitability. | |
| Residual Volume: Data generated and performance indicates suitability. | |
| % White Blood Cell (WBC) Removal: Data generated and performance indicates suitability. | |
| Residual WBC Count: Data generated and performance indicates suitability. | |
| % RBC Recovery (on packed red blood cells): Data generated and performance indicates suitability. | |
| Platelet Count (with platelets): Data generated and performance indicates suitability. | |
| Morphology (with platelets): Data generated and performance indicates suitability. | |
| pH (with platelets): Data generated and performance indicates suitability. | |
| % pH Change (with platelets): Data generated and performance indicates suitability. | |
| % LDH Change (with platelets): Data generated and performance indicates suitability. | |
| C3a/C5a Complement Activation (with platelets): Data generated and performance indicates suitability. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the functional performance tests. It also does not mention the provenance (country of origin, retrospective or prospective) of the data. The studies are described as "Data regarding the functional performance...have been generated," implying prospective testing conducted in a laboratory setting, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The testing for a blood transfusion filter involves objective measurements of physical and chemical properties (e.g., flow rate, filtration efficiency, hemolysis, cell counts, pH) rather than subjective expert interpretation or "ground truth" derived from expert consensus.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. The functional performance tests involve direct measurements and comparisons, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of device. An MRMC study is typically used for diagnostic devices where human readers interpret medical images or data. This submission is for a physical filtration device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical filter, not an algorithm. The performance described is inherently standalone, as it's the filter's performance in laboratory tests.
7. Type of Ground Truth Used
The ground truth for the performance tests is based on objective laboratory measurements and established scientific/biological methodologies. For example, filtration efficiency is determined by measuring microaggregate removal, hemolysis by quantifying red blood cell lysis, and WBC removal by counting cells. This is not "expert consensus," "pathology," or "outcomes data" in the conventional sense, but rather direct empirical evidence from controlled experiments.
8. Sample Size for the Training Set
This device does not involve a "training set" in the context of machine learning or AI models. Therefore, the sample size for a training set is not applicable. The studies described are testing the performance of a physical product.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question is not applicable.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.