(165 days)
The Safety Subcutaneous Infusion Set is designed specifically for the delivery of medications to the subcutaneous tissue.
The safety subcutaneous needle infusion set consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The unique Single, Bifurcated, Trifurcated, Quadfurcated, 5 and 6 Lumen for the Sub-Q have a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end. The sets are convenient to use, associated with less trauma, and offer an opportunity to improve compliance cost-effectively through the use of a dedicated infusion set. The device is for single use only.
The provided text is for a K120195 510(k) summary for a "Safety Subcutaneous Tissue Infusion Set". This is a medical device and not an AI/ML powered device. As such, the information you've requested regarding acceptance criteria and a study proving device performance in the context of AI/ML, human readers, ground truth, and training data is not applicable to this document.
This document describes a traditional medical device (an infusion set) and primarily focuses on its substantial equivalence to a predicate device based on design, materials, intended use, and function, rather than performance metrics from a study with acceptance criteria as one would find for an AI/ML algorithm.
Therefore, I cannot provide details on the requested criteria because the document does not contain information about:
- Acceptance criteria and reported device performance in the context of an AI model. The performance testing mentioned ("Foreign Matter Tests (to Tappi Standards). Occlusion Test - no occlusions, Leak Test - no leaks, Safety Button Test - no failures.") are basic engineering/material tests for the physical device, not a measure of diagnostic or predictive accuracy.
- Sample size for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document's purpose is to demonstrate that the new "Safety Subcutaneous Tissue Infusion Set" is substantially equivalent to a previously cleared device (Marcal Medical, Inc. K082818) by comparing their design, materials, intended use, and function.
§ 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.