(50 days)
The Fenwal® 20 Micron Pediatric Transfusion Filter is indicated for the removal of microaggregate particles from whole blood and red blood cells.
Baxter's Fenwal® 20 Micron Pediatric Transfusion Filter is a depth-type filter which traps microaggregates composed of degenerating platelets, leukocytes, fibrin strands and other particles which form in blood after storage. The filter consists of a fiber pad supported by a screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. The filter pad is currently comprised of five types of fiber strands. The supplier of one of the fibers has discontinued production. We are proposing to eliminate two of the five fibers used in construction of the filter pad and increase the percentage composition of the remaining three sizes. This change will make the composition of the 20 micron pediatric filter pad identical to the composition of the pad in the Fenwal® 20 Micron High Capacity Transfusion Filter covered by K830057.
The provided text describes a 510(k) Premarket Notification for a modified Fenwal® 20 Micron Pediatric Transfusion Filter (K982822). The submission focuses on a change in the fiber composition of the filter pad, rather than a new AI-powered diagnostic device. Therefore, the specific questions regarding acceptance criteria and studies for AI performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not directly applicable to this document.
However, I can extract the relevant information regarding the performance of this medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Performance testing indicates that the modified device meets or exceeds all functional requirements and supports its suitability for use." While specific numerical acceptance criteria are not detailed in the provided summary, the key performance aspects evaluated were:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Filter Efficiency (% microaggregate removal) | The modified device's performance in filter efficiency meets or exceeds the current device. Specific quantitative details (e.g., percentage removal threshold) are not provided in this summary. |
| Filtration Integrity (% hemolysis) | The modified device's performance in filtration integrity (specifically, % hemolysis) meets or exceeds the current device. Specific quantitative details are not provided. |
| Filtration Integrity (red blood count) | The modified device's performance in filtration integrity (specifically, red blood count) meets or exceeds the current device. Specific quantitative details are not provided. |
| Filter Capacity | The modified device's performance in filter capacity meets or exceeds the current device. Specific quantitative details (e.g., volume processed before occlusion) are not provided. |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a nonclinical performance comparison of the proposed modified filter with the current Fenwal® 20 Micron Pediatric Transfusion Filter.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document only mentions "Test data has been generated comparing the performance... using packed red blood cells."
- Data Provenance: The tests were nonclinical (laboratory-based) and used "packed red blood cells." The country of origin for the data is not specified, but given Baxter Healthcare Corporation's location in Round Lake, IL, USA, it is highly likely the testing was conducted in the USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence of the new filter design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. This is a medical device performance study, not an AI diagnostic study requiring expert consensus for ground truth. The "ground truth" here refers to the measured physical performance characteristics of the filter (e.g., actual microaggregate removal percentage, actual hemolysis percentage) in a controlled laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. Adjudication methods are relevant for human interpretation or AI output reviews, not for direct physical performance measurements of a medical device.
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 question is not applicable. This device is a passive filtration device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This device is not an algorithm.
7. The type of ground truth used:
The ground truth used was empirical measurement of physical performance characteristics (e.g., filter efficiency, hemolysis, red blood count, filter capacity) of the filter, likely against established industry standards or internal specifications for the existing predicate device.
8. The sample size for the training set:
This question is not applicable. There is no AI model or "training set" for this physical device.
9. How the ground truth for the training set was established:
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.