(89 days)
The MiniMed Sof-set Ultimate QR infusion set is indicated for the subcutaneous delivery of medicine, including insulin, from an external infusion pump.
The MiniMed Sof-set Ultimate QR infusion sets, models 315 and 316, are infusion administration sets, connecting to a medicine 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 the MiniMed 507 insulin pump.
The administration set attaches to the reservoir syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of FEP Teflon. 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 needle, indwelling catheter, and tubing share a common hub. The hub incorporates a winged configuration to facilitate handling of the administration set during insertion and stability following insertion.
On the skin-contact side of the wings, around the Teflon catheter, is an antibacterial dressing. Additionally, an adhesive dressing covers the wings of the administration set, securing the subcutaneous catheter and infusion line to the user.
This 510(k) premarket notification for the MiniMed Sof-set Ultimate QR infusion set does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the way typically expected for a software or AI-driven medical device.
The document is a submission for a modified physical device (an infusion set for insulin delivery), not a diagnostic algorithm or a device relying on complex data analysis and ground truth establishment. Therefore, many of the requested categories in your prompt (like "number of experts," "adjudication method," "MRMC study," "training set size") are not applicable to this type of regulatory submission.
The "study" referenced in this document implicitly refers to the comparison of the new device to its predicate device and the general safety and effectiveness standards for such devices. The "acceptance criteria" are whether the modifications ensure the device remains safe and effective for its intended use, and importantly, whether it is "substantially equivalent" to the predicate device.
Here's an attempt to answer your questions based on the provided text, while also highlighting why some are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Substantial Equivalence: The new device (Sof-set Ultimate QR) must be substantially equivalent to the predicate device (Sof-set QR) in terms of safety and effectiveness for its intended use. | The FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." The modifications "do not affect the safety or effectiveness of the device." |
| Intended Use: The device must be suitable for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. | The device's intended use is precisely stated as: "subcutaneous delivery of medicine, including insulin, from an external infusion pump." This aligns with the predicate. |
| Materials Compatibility & Safety: Materials used must be safe for patient contact and compatible with the infused medicine. | "Both devices are made of substantially similar materials." (PVC, polyolefin, FEP Teflon, stainless steel). The specific change to higher density polyethylene in the tubing inner layer is mentioned as resulting in a "more sensitive occlusion alarm," implying an improvement in safety rather than degradation. |
| Functionality (e.g., occlusion detection): The device should function reliably, potentially with improved safety features. | The higher density polyethylene in the inner layer of the tubing reportedly "has resulted in a more sensitive occlusion alarm, which will be promoted by MiniMed." This indicates an improvement in a safety-critical function. |
| Biocompatibility: Materials in contact with the body must be biocompatible. | "On the skin-contact side of the wings, around the Teflon catheter, is an antibacterial dressing." This suggests existing measures for biocompatibility and infection control. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. For physical device modifications like this, testing typically involves bench testing, limited animal studies (if applicable), and potentially human factors testing, but the numerical details are not provided. There is no "test set" in the sense of a dataset for an algorithm.
- Data Provenance: Not explicitly stated. The submission is from MiniMed Inc. in the USA. The implied testing would likely be internal to the manufacturer or conducted by contract research organizations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device modification, not an AI or diagnostic algorithm requiring expert "ground truth" establishment for data annotation. Expert input would relate to engineering, clinical safety, and regulatory compliance.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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 not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the traditional sense. The "ground truth" for a physical device like this is its ability to perform its intended function safely and effectively, as demonstrated through engineering testing, biocompatibility assessments, and clinical performance data (often compared to a predicate device). The ultimate "ground truth" in regulatory terms is that the device is "substantially equivalent" to a legally marketed predicate device, meaning it doesn't raise new questions of safety or effectiveness.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Device and Regulatory Context (Based on the text):
This 510(k) submission describes minor modifications to an existing insulin infusion set. The core argument for regulatory clearance is substantial equivalence to an already marketed predicate device. The changes are largely focused on manufacturing improvements, hub configuration, adhesive, and tubing material, with one noted improvement being a "more sensitive occlusion alarm." The FDA's letter confirms their agreement that the device is substantially equivalent, allowing it to be marketed.
What would constitute "proof" in this context are internal engineering tests (e.g., tensile strength of materials, flow rate, occlusion detection sensitivity testing, biocompatibility studies, sterilization validation) which are typically summarized and submitted to the FDA but not detailed in this public-facing 510(k) summary. The "acceptance criteria" are implicitly met if these tests demonstrate that the modifications haven't negatively impacted safety or effectiveness, and in some cases, have improved them (like the occlusion alarm).
§ 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.