(392 days)
The Extended Reservoir is indicated for the subcutaneous infusion including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
Extended Reservoir (herein referred to as "EWR" or "MMT-342") is a sterile medication container designed for single use. The Extended Reservoir (MMT-342) is a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring subcutaneous administered insulin, to maintain acceptable blood glucose levels. The Extended Reservoir (subject device) is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
The provided text describes a 510(k) premarket notification for an "Extended Reservoir" (MMT-342) by Medtronic MiniMed, Inc. The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device (Medtronic MiniMed Paradigm Reservoir MMT-332A, K032005) while extending the duration of use from 3 days to 7 days.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion is to demonstrate that extending the duration of use for the reservoir from 3 days to 7 days does not negatively impact the safety and effectiveness of the device. Since there are no changes in hardware design, materials, manufacturing, packaging, sterilization processes, fluid capacity, insulin compatibility, or reservoir assembly, the acceptance criteria are implicitly tied to maintaining the performance characteristics of the predicate device over the extended duration.
The text does not provide a specific table of quantitative acceptance criteria for parameters like insulin delivery accuracy, occlusion detection, or material degradation. Instead, it states that "The test results demonstrate that MMT-342 (subject device) met all the product requirements and specifications of MMT-332A (predicate device)." This implies that the performance over 7 days matches the established performance standards of the 3-day predicate.
The reported device performance, in summary, is that the Extended Reservoir (MMT-342) successfully maintains the same safety and effectiveness as the predicate device (MMT-332A) when used for up to 7 days.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Maintain product requirements & specifications of MMT-332A for 7 days | MMT-342 met all product requirements & specifications of MMT-332A |
| No new hazards or failure modes with extended use | Risk analysis found no additional questions of safety & effectiveness with 7-day use |
Study Details
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Sample size used for the test set and the data provenance:
The document states: "Medtronic performed verification testing to support extending the duration of the reservoirs use (from up to 3 days to up to 7 days)." However, the specific sample size for this verification testing is not provided in the extracted text.
The provenance of the data is not explicitly mentioned (e.g., country of origin, retrospective/prospective). It is implied to be internal testing conducted by Medtronic. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the extracted text. The verification testing described is likely technical performance testing rather than human expert assessment of a medical condition. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes technical verification testing, not a clinical study involving adjudication of clinical observations. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is an insulin reservoir, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device (insulin reservoir), not a software algorithm. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
For mechanical/material performance, the "ground truth" would be established engineering specifications and validated test methods (e.g., for infusion accuracy, material integrity, sterility maintenance). The document indicates that the subject device "met all the product requirements and specifications of MMT-332A." This implies the predicate device's established performance standards serve as the ground truth. -
The sample size for the training set:
This information is not applicable as the device is a physical medical device, not a machine learning model. -
How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 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).