(57 days)
The Medtronic MiniMed Paradigm Polyfin QR MMT-312L and MMT-312S are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.
The Paradigm Polyfin QR MMT-312L and MMT-312S are disposable single-use infusion set intended for use with Medtronic MiniMed external microinfusion pumps.
This submission for the Medtronic MiniMed Paradigm Polyfin QR Infusion set (K031917) is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than demonstrating de novo safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This submission focuses on comparison to a predicate device ("Polyfin™ QR® with Wings Infusion set, Model MMT-365 and MMT-366") to establish substantial equivalence.
Here's why the requested information is absent:
- Acceptance Criteria & Device Performance: The document states, "The new and predicate devices have similar materials and basic design." It also mentions "The new devices include a proprietary connector for connection to a Paradigm reservoir whereas the predicate devices use a standard luer connection." This comparison of features is used to argue substantial equivalence, not to hit specific performance metrics or acceptance criteria derived from a study.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): A 510(k) summary typically summarizes device characteristics and predicate device comparison. It does not typically include detailed clinical study protocols, results, or data provenance, as the primary pathway for 510(k) is often non-clinical testing (e.g., bench testing, biocompatibility) demonstrating that the new device performs as safely and effectively as the predicate, or that differences do not raise new questions of safety and effectiveness.
To answer your specific questions in the context of this 510(k) submission, the best I can do is state that this information is not present in the provided text.
In summary, the provided document is a 510(k) summary for a medical device that establishes substantial equivalence to a predicate device. It does not describe an acceptance study with performance criteria and detailed study parameters as typically seen in a premarket approval (PMA) application or a de novo classification.
§ 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.