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The Insulin Pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The new and predicate devices have similar materials and basic design and technology.

This K051041 document is a 510(k) summary for the Abbott Diabetes Care Insulin Pump, seeking substantial equivalence to the Medtronic MiniMed 515. The provided text does not include specific acceptance criteria or a study detailing device performance against such criteria. The document focuses on regulatory submission without performance data.

Therefore, I cannot provide the requested information from the given text.

The document states:

• No performance standard(s) or special controls applicable to this device have been promulgated under Section 514 of the Act. This means the FDA has not set specific performance metrics that this device must meet in the same way some other medical devices might have.
• The new and predicate devices have similar materials and basic design and technology.
• The Pump has the same target users and operating environment as predicate devices.
• A comparison of product features and performance characteristics of the previously cleared Medtronic MiniMed Paridigm 515 [510(k) #K040676] and the TheraSense, Inc. Insulin Pump is provided within the substantial equivalence discussion below. (However, the "discussion below" is not included in the provided snippets).

To answer your questions, I would need a section of the 510(k) submission that details the performance testing conducted for the Abbott Diabetes Care Insulin Pump to demonstrate its safety and effectiveness, and how that performance compares to specified acceptance criteria (which would likely be derived from the predicate device).

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