Search Results

Blood Product Specialties Pedi-Syringe Filter™ is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion.

Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp.

The provided text is a 510(k) premarket notification for a medical device called the "Pedi-Syringe Filter™". The document discusses the device's intended use and FDA's substantial equivalence determination, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary (page 1, section "Device Description") describes the device as a "Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp."

The "Intended Use" (page 1) states: "Intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets plasma and cryoprecipitate for pediatric and/or neonatal transfusion."

The FDA's letter (pages 2-4) confirms that the device is "substantially equivalent" to a legally marketed predicate device (Charter Medical Neonatal Syringe Set K000685). This substantial equivalence determination means that the FDA believes the new device is as safe and effective as the predicate device already on the market. However, a 510(k) submission primarily focuses on demonstrating substantial equivalence, and it does not typically require or present detailed performance acceptance criteria and a study report demonstrating the device meets those criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information from the given text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number of experts used or their qualifications for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI.
6. Information about a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth was established for a training set.

This document is a regulatory approval notice based on substantial equivalence, not a detailed performance study report.

Ask a specific question about this device