(17 days)
The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.
The ADR THINSet Insulin Infusion Set facilitates the flow of medication from an infusion pump reservoir into the subcutaneous tissue of the user. The infusion set consists of a female luer, tubing, Needle Grip with introducer needle and Base Assembly. The Base Assembly consists of three components: the Needle Grip, Connector and Base. The Needle Grip contains the 26 guage introducer needle that penetrates the subcutaneous tissue. The infusion set tubing attaches to the Connector. The Connector may be removed from the Base. The Base houses the 24 gauge Cannual and has a medical grade adhesive dressing attached to the bottom. The infusion set is packaged sterile in a Tray Pack. The infusion set is available with 23 and 43 inch tubing lines and 6 and 9 mm Cannulas.
The provided 510(k) summary for the ADR THINSet Insulin Infusion Set (K033099) describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria values or detailed performance metrics in a quantified format as requested by the user for a comprehensive table.
Instead, the document primarily focuses on qualifying the testing performed and stating that the device "meets the requirements" or that "differences were insignificant." It also lacks details about ground truth establishment, expert qualifications, sample sizes for specific tests, or a multi-reader multi-case (MRMC) study.
Therefore, the response below will reconstruct the information available as closely as possible to the requested format, clearly indicating where specific numerical data is absent in the original document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Acceptance Criteria (Stated or Implied) | Reported Device Performance/Conclusion |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Meet requirements of ISO-FDA Modified Matrix, FDA/ODE G95-1, ANSI/AAMI/ISO 10993-1:1997 for an External communicating device, Blood path, indirect for |
§ 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.