(81 days)
The MiniMed Sof-set Micro QR infusion set is indicated for the subcutaneous infusion of medicine, including insulin, from an external infusion pump.
The MiniMed Sof-set Micro QR infusion sets, models 320 and 321. are infusion administration sets, connected to a medication reservoir proximally and inserted in the subcutaneous tissue of a user distally by means of an introducer needle. The reservoir to which the infusion set attaches proximally is inserted into an external infusion pump, such as a MiniMed infusion pump.
The administration set attaches to the reservoir by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of Fluorinated Ethylene Propylene (FEP). The tubing is made of polyvinyl chloride (PVC) with a polyolefin liner. This configuration of PVC and polyolefin has been trademarked by MiniMed as Polyfin®.
The 24 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 26 gauge introducer needle made of 304 stainless steel. The indwelling catheter and tubing share a common hub through which the introducer needle fits. The hub incorporates a winged configuration with an adhesive patch to facilitate handling of the administration set during insertion and stability following insertion. An adhesive dressing covers the wings and hub of the administration set, securing the subcutaneous catheter and infusion line to the user.
The provided text describes a 510(k) submission for a medical device (MiniMed Sof-set Micro QR infusion sets) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, MiniMed Sof-set Ultimate™ QR infusion sets.
Here's what can be inferred from the document regarding the device and its comparison, even though it doesn't fit the requested format of acceptance criteria and performance study:
1. Acceptance Criteria and Reported Device Performance:
The document does not list specific acceptance criteria or report performance metrics in a quantitative manner. Instead, it claims "These modifications do not affect the safety or effectiveness of the device."
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No performance test set is described. The comparison is based on design modifications and materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication method is described.
5. 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 medical device (infusion set), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device (infusion set), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The submission relies on demonstrating substantial equivalence through comparison of design, materials, manufacturing processes, and intended use with a legally marketed predicate device, rather than a new clinical study with a defined ground truth.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (infusion set), not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As above, this is not an AI/algorithm-based device requiring a training set.
Summary of what the document does provide:
- New Device Name: MiniMed Sof-set Micro QR infusion sets, models 320 and 321.
- Predicate Device Name: MiniMed Sof-set Ultimate™ QR infusion sets, models 315 and 316.
- Intended Use: Subcutaneous infusion of medicine, including insulin, from an external infusion pump.
- Key Differences from Predicate Device:
- Shorter catheter (6mm vs 9mm).
- Shorter introducer needle (shortened by 3mm).
- Larger adhesive patch.
- Modified wing radius.
- Claim for Substantial Equivalence: "The modified device is substantially similar to the lawfully marketed predicate device. Both are intended for subcutaneous delivery of insulin or other appropriately labeled medication from an infusion pump to the pump user. Both sets attach proximally to a reservoir by means of a Luer connector, and insert distally into the device user's subcutaneous tissue with a removable stainless steel needle and flexible catheter. The materials and manufacturing processes are the same for the modified and predicate devices. ... These modifications do not affect the safety or effectiveness of the device."
This document is a regulatory submission for a physical medical device, not an AI or algorithm-based product, which explains the absence of the requested AI-centric study details.
§ 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.