(82 days)
The Medtronic MiniMed Paradigm Model 712 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Paradigm Model 712 is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 0.00 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal bolus. This pump will include a bolus estimator feature that can be tailored to an individual user's insulin sensitivity, insulin to carbohydrate ratio, and target BG (Blood Glucose). Also, there is a BG reminder feature, allowing the user to set daily and post-bolus reminders to check BG readings. The insulin programming step size will allow users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units for basal delivery. The Model 712 accommodates a proprietary 3.0 ml reservoir. This new reservoir mates with the existing and future Paradigm infusion sets.
The provided text is a 510(k) premarket notification for the Medtronic MiniMed Paradigm Model 712 Insulin Pump. It establishes substantial equivalence to a predicate device (Medtronic MiniMed Paradigm Model 511 Insulin Pump) rather than presenting a standalone study with acceptance criteria and performance data.
Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format requested.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: The document discusses the device's features, but not specific performance metrics against predefined acceptance criteria.
- Sample sized used for the test set and the data provenance: No test set or data provenance details are mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information regarding ground truth establishment or experts is present.
- Adjudication method: Not applicable as no test set evaluation is described.
- Multi reader multi case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not described.
- The type of ground truth used: No ground truth is discussed.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: Not applicable as no training set ground truth is discussed.
The document focuses on:
- Device Name: Medtronic MiniMed Paradigm Model 712 Insulin Pump
- Indications for Use: Continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
- Predicate Device: Medtronic MiniMed Paradigm Model 511 Insulin Pump
- Key Differences from Predicate: Larger case, software modifications including a Bolus Wizard feature (which assists users in calculating insulin boluses based on personalized settings like insulin sensitivity, insulin to carbohydrate ratio, and target blood glucose), and a 3.0 ml reservoir.
- Insulin Programming Step Size: 0.1 units for boluses and 0.05 units for basal delivery.
§ 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).