(77 days)
The Paradigm Countach infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an infusion pump and reservoir. The set is not intended nor indicated for use with blood or blood products.
The Medtronic MiniMed Paradigm Countach infusion set Model MMT-310 is a disposable, single-use intended for use with Medtronic MiniMed external microinfusion pumps. The Paradigm Countach is an infusion set that uses a cannula with a disconnect.
The provided text is a 510(k) summary for the Medtronic MiniMed Paradigm Countach Infusion set Model MMT-310. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/ML device.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of studies are not typically part of a 510(k) submission for a non-AI/ML medical device like an infusion set.
The 510(k) process for this type of device typically relies on:
- Comparison to a predicate device: Demonstrating that the new device is substantially equivalent in terms of intended use, technological characteristics, and safety and effectiveness to a device already legally marketed.
- Bench testing: Evaluating physical and mechanical properties (e.g., tensile strength, flow rate) to ensure it meets design specifications.
- Biocompatibility testing: Ensuring materials are safe for human contact.
- Sterility testing: Verifying the device is sterile.
The document states:
- Predicate Devices: Maersk Medical A/S Paradigm Silhouette Infusion sets Models MMT-377, 378, 379. 380 (Premarket notification K002138)
- Comparison of Technological Features: "The Paradigm Countach infusion set is substantially similar to the lawfully marketed predicate device. Both sets are intended for subcutaneous delivery of insulin from the infusion pump to the pump user and attaches proximally to a reservoir by means of a proprietary plastic connector, and insert distally into the device user's subcutaneous tissue with a removable stainless steel needle and a flexible catheter."
This indicates that the "study" for this device was primarily a comparison of its features and performance to those of an established predicate, supported by standard engineering and biocompatibility tests, rather than a clinical study with acceptance criteria for a novel performance metric.
§ 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.