(36 days)
The Medtronic MiniMed Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6. MMT-358M6. MMT-358L6. MMT-358S9. MMT-358M9. and MMT-358L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir. The infusion sets attach to the medication reservoir by means of a female Luer connector. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.
This document describes the Medtronic MiniMed Sof-site Infusion Sets and their 510(k) premarket notification (K030137). However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or a study detailing how the device met such criteria.
The document is a 510(k) summary and the FDA's clearance letter, which primarily focus on:
- Device Description and Intended Use: Explains what the device is and what it's used for (subcutaneous insulin infusion).
- Predicate Device Comparison: States that the modified device has similar materials and features to predicate devices, with the exception of the at-site connection mechanism, which is deemed not to affect safety or effectiveness.
- Substantial Equivalence: The FDA's determination that the new device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable to infusion sets in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and not applicable as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not applicable in the way you're likely thinking (e.g., pathology for AI). Compliance with standards and in-vitro/in-vivo testing would typically be used for such products, but details are not provided.
- The sample size for the training set: Not applicable and not mentioned.
- How the ground truth for the training set was established: Not applicable and not mentioned.
The document essentially states that the new device is considered safe and effective because it is substantially equivalent to existing, predicate devices, and a specific modification to the connection mechanism does not impact this equivalence. There is no detailed study methodology or performance data provided in this particular excerpt.
§ 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.