(64 days)
The Medtronic MiniMed Paradigm Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
The Medtronic MiniMed Paradigm Sof-site infusion sets, models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir. The infusion sets attach to the medication reservoir by means of a proprietary connecter. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue of the user 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. The adhesive patch is integral to the base and is used to secure the unit to the user.
The provided text is a 510(k) summary for the Medtronic MiniMed Paradigm Sof-site infusion sets. This document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical validation study for an AI/ML device would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) summary uses a comparison of technological features to demonstrate equivalence in safety and effectiveness, rather than a performance study against specific, quantified acceptance criteria for a new clinical function or AI algorithm.
Below is an attempt to address the prompts based on the available information, noting where the information is not present or relevant to this type of regulatory submission.
Acceptance Criteria and Device Performance
This 510(k) submission establishes substantial equivalence for the Medtronic MiniMed Paradigm Sof-site infusion sets by demonstrating that it is as safe and effective as its predicate devices, the Medtronic MiniMed Paradigm Quick-set and Sof-set Ultimate QR infusion sets. The "acceptance criteria" in this context are primarily qualitative and relate to the device sharing similar technological characteristics and materials of construction, and that any modifications (specifically to the distal connect mechanism) do not affect safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance/Comparison (from 510(k) Summary) |
|---|---|---|
| Intended Use | Must be the same as or very similar to predicate devices. | "Intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump." (Identical to predicate's intended use). |
| Materials of Construction | Must be similar to predicate devices. | "The modified device and the lawfully marketed predicate devices contain similar materials of construction." |
| Technological Features (General) | Must be comparable to predicate devices. | "Features of the modified device are comparable to those of the predicate devices..." |
| Specific Modification: Distal Connect Mechanism | The modification must not affect the safety or effectiveness of the device compared to the predicate. | "The modified mechanism does not require specific alignment to the site as is currently required in the predicate devices. This modification does not affect the safety or effectiveness of the device." (This asserts the modification maintains safety and effectiveness, meeting the implicit acceptance criterion). |
| Safety and Effectiveness | Must be demonstrated to be as safe and effective as predicate devices. | Achieved through demonstrating similar materials, intended use, and technological features, and by asserting the modification does not affect safety or effectiveness. No specific quantitative safety/effectiveness metrics are presented in this summary, as is typical for 510(k)s showing equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an algorithm or diagnostic device. The evaluation is based on comparison to predicate devices and an assessment of the impact of the design modification.
- Data Provenance: Not applicable. There is no mention of country of origin of data or whether it was retrospective or prospective, as no formal clinical data study is detailed for the new device's performance against specific metrics.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of expert consensus on outcomes for a test set, is not described as part of this 510(k) submission. Regulatory review for 510(k) relies on regulatory experts at the FDA assessing the submission's claims of substantial equivalence based on engineering and design principles, existing predicate data, and non-clinical testing (if any were detailed, which it is not in this summary).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set or associated adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not applicable. This is not an AI/ML or diagnostic imaging device that would typically undergo an MRMC study to compare human reader performance with and without AI assistance. The device is an infusion set.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Not applicable. This is a medical device (infusion set), not an algorithm or AI system, so the concept of "standalone performance" for an algorithm does not apply.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of expert consensus, pathology, or outcomes data for a performance study. For this 510(k), the "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices and the argument that the new device shares similar technological characteristics and materials, and that its modification does not compromise safety or effectiveness.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.