(77 days)
The 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 Countach infusion set Model MMT-313 is a disposable, single-use infusion set intended for use with Medtronic MiniMed external micro-infusion pumps. The Countach is an infusion set that uses a cannula with a disconnect.
The design will feature improved ergonomics to achieve a low profile, pre-attached adhesive system. tubing lengths. and multiple soft cannula lengths for different body types.
The provided text describes a 510(k) premarket notification for the Medtronic MiniMed Countach Infusion set Model MMT-313. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study data on performance against specific acceptance criteria.
Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance, the study that proves the device meets those criteria, sample sizes, expert ground truth details, adjudication methods, MRMC studies, standalone performance studies, training set details, or how ground truth was established for training and testing.
The document primarily states:
- Intended Use: The Countach infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.
- Comparison to Predicate: The Countach infusion set is stated to be "substantially similar to the lawfully marketed predicate device," the Macrsk Medical A/S Paradigm Silhouette Infusion sets Models MMT-371, 372, 373 and 374 (K972135).
- Design Features: The design will feature improved ergonomics to achieve a low profile, pre-attached adhesive system, tubing lengths, and multiple soft cannula lengths for different body types.
The FDA's review in this context is to determine if the new device is "substantially equivalent" to an already approved device, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness questions, or if it has different technological characteristics but those do not raise new questions and the information submitted demonstrates that the device is as safe and effective as the predicate device. This process typically relies on bench testing, performance testing, and comparison of technical specifications rather than extensive clinical efficacy studies with predefined acceptance criteria as might be expected for a PMA submission or a novel device.
§ 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.