(82 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or data provenance.
- Number of experts used or their qualifications for ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI.
- Information about a standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- 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.
§ 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.