(49 days)
The SA.ER Multi-Lumen Extension Sets are to be used for the intravascular The SA.ER Multi-Lumen Extension Sets are to be used Icro the intravascular system.
SA.EF Multi-Lumen Extension Set
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "SA.EF Multi-Lumen Extension Set." This letter states that the device is "substantially equivalent" to predicate devices, meaning it doesn't require new clinical studies to prove safety and effectiveness.
Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way that would be applicable to a new, non-substantially equivalent device or an artificial intelligence/machine learning (AI/ML) device.
The questions you've asked are typically relevant for new devices requiring clinical trials or for AI/ML-driven medical devices that need to demonstrate their performance against a defined ground truth. Since this is a 510(k) clearance based on substantial equivalence, those types of detailed studies, acceptance criteria, and performance metrics are not included in this regulatory document.
However, based on the general information provided, I can state the following regarding your questions, noting that much of the information you requested would not be present in a 510(k) clearance letter:
- A table of acceptance criteria and the reported device performance: Not applicable. The document establishes substantial equivalence, not performance against specific, new acceptance criteria. No performance data is reported.
- Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment occurred as part of this 510(k) submission.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is a physical medical device, not an AI/ML algorithm.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: 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.