(143 days)
The Sof-set and Polyfin families of infusion sets are indicated for the subcutaneous infusion of medication, including insulin, from a Medtronic MiniMed infusion pump and reservoir.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Polyfin Infusion Set" and related models. It explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.
A 510(k) clearance evaluates substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. This process does not typically involve detailed studies to establish new acceptance criteria or quantify device performance against specific metrics in the way a PMA (Premarket Approval) or a clinical trial for a novel device would. The provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria as you've requested.
The information you are asking for, such as sample size, ground truth establishment, expert qualifications, and specific performance metrics, is usually found in detailed scientific reports, clinical trial summaries, or design validation documents that are submitted to the FDA as part of the 510(k) but are not typically included in the public-facing clearance letter itself.
Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria because this information is not present. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device, rather than providing detailed performance data against new acceptance criteria.
The information you've requested typically comes from the technical documentation and studies submitted to the FDA, which are not included in this summary letter.
§ 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.