(30 days)
The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.
The D-TRONplus Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows settings of 0.0 to 25.0 units in 0.1 unit increments of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per bolus in 0.1, 0.2, 0.5, or 1.0 unit increments.
The provided text is a 510(k) summary for the Disetronic D-TRONplus Insulin Infusion Pump. It states that "Testing of the D-TRONplus demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the D-TRONplus is substantially equivalent to the predicate device." However, the document does not contain the specific acceptance criteria or the detailed results of the study that proves the device meets those criteria.
Therefore, I cannot provide most of the requested information. The text does not elaborate on:
- A table of acceptance criteria and the reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts used for ground truth.
- Adjudication method for test sets.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Details about a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on establishing substantial equivalence to a predicate device (Disetronic D-TRONplus Insulin Infusion Pump, K#022831) rather than detailing specific performance metrics against defined acceptance criteria.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).