(69 days)
The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps.
The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.
The purpose of this submission is to offer an alternate 0.2u filter, as a matter of customer preference, for use with the SIMS Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2u Filter and Anti-Siphon Valve. The 0.2u filter is similar to the filter on the Abbott Laboratories' Filter Set with 0.22u Filter. An integral anti-siphon valve is included and is designed to protect against unregulated gravity infusion that may result from an improperly attached reservoir.
The provided text is a 510(k) summary for a medical device (Extension Set with 0.2µ Filter and Anti-Siphon Valve and CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve). However, it describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document states that the purpose of the submission is to offer an alternate 0.2µ filter, similar to one on an existing Abbott Laboratories' product. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than presenting a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested table and detailed study information based on the given text. The provided document is a regulatory submission for premarket notification, not a performance study report.
No information is available in the provided text for the following requests:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.