(84 days)
The Medtronic MiniMed Paradigm Leapfrog II Infusion Set is indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
The Medtronic MiniMed® Paradigm™ Leapfrog II Infusion Set, models MMT-802S1, MMT-802L1. MMT-802S2, MMT-802L2, MMT-804S1, MMT-804L1, MMT-804S2, and MMT-804L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump.
The infusion administration set attaches proximally to a medication reservoir by means of a proprietary connector and is inserted into the subcutaneous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutancous 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.
The provided 510(k) premarket notification for the Medtronic MiniMed Paradigm Leapfrog II Infusion Sets does not contain specific acceptance criteria or a detailed study report demonstrating how the device meets such criteria in the way that would be typical for a software or AI-driven medical device.
This document describes a medical device (infusion set) which is a physical product, not a diagnostic algorithm or a device with performance metrics like sensitivity, specificity, or AUC that would be generated from a study. Therefore, most of the requested information (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable to this type of device submission.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on similar materials of construction and intended use, with a minor modification to an attachment mechanism that is asserted not to affect safety or effectiveness.
Here’s a breakdown of the relevant information provided, and why much of the requested detail is absent:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" in terms of quantitative performance metrics (like accuracy, sensitivity, specificity) for a study are provided in this document. The "acceptance" is implied by the FDA's declaration of substantial equivalence based on the technological features and intended use being similar to existing legally marketed devices.
The key acceptance criteria for this type of device (an infusion set) would typically revolve around:
- Biocompatibility: Materials used are safe for contact with the human body.
- Sterility: The product remains sterile until opened.
- Functionality:
- Proper fluid delivery without leakage or blockage.
- Secure connection to the infusion pump and at the insertion site.
- Ease of insertion and removal.
- Durability: Withstands normal use conditions.
- Safety: No adverse effects due to material or design.
The document states: "The modified device and the lawfully marketed predicate devices contain similar materials of construction. Features of the modified device are comparable to those of the predicate devices with the exception of the modified attachment mechanism that offers multiple alignments and locking sites for the attachment to the site connection. This modification does not affect the safety or effectiveness of the device."
This statement is the reported device performance relative to the implicit acceptance criteria of maintaining safety and effectiveness comparable to the predicate devices. No quantitative data or specific test results are presented in this summary document to prove this assertion. Such proofs would typically be in the full submission, but not summarized here in the way requested for software performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. For a physical medical device like an infusion set, testing would involve manufacturing tests, material compatibility tests, flow rate tests, and possibly simulated use or in-vivo animal/human trials for safety and effectiveness. However, no details on test sample sizes or data provenance are included in this 510(k) summary. Given it's a submission to the US FDA by a US-based company, any testing would presumably align with US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable and not provided. "Ground truth" in the context of expert consensus is typically used for diagnostic or AI-powered devices where human interpretation is involved. For a physical infusion set, validation typically relies on engineering specifications, material science, and performance testing, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided for the same reasons as #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
This is not applicable. MRMC studies are used for evaluating diagnostic performance, especially of imaging systems or AI tools. This device is an infusion set, a delivery mechanism, not a diagnostic tool, and involves no "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical infusion set; there is no "algorithm" or standalone "performance" in the computational sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an infusion set, the "ground truth" would be established by objective measurements against engineering specifications (e.g., flow rate accuracy, connection strength, material integrity, sterility testing conforming to standards), and ultimately by clinical safety and effectiveness through clinical trials if a novel design warranted it (though in 510(k) context, substantial equivalence to predicates often mitigates the need for extensive new clinical data). This document does not detail the specific ground truth types or methods used, beyond the assertion of comparability.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" as this is not an AI/ML device.
In summary: The provided document is a 510(k) summary for a physical medical device (an infusion set). Its acceptance by the FDA is based on demonstrating substantial equivalence to predicate devices, not on meeting specific quantitative performance metrics from a study described in the way you've outlined for AI or diagnostic devices. The summary asserts that a modification to the device does not affect its safety or effectiveness, implying that existing testing methods and standards for the predicate devices apply.
§ 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.