(27 days)
MiniMed Reservoir- This Reservoir 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 compatibility.
Extended Reservoir- The Extended Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
The MiniMed family of reservoirs (MMT-326A, MMT-342, MMT-342, MMT-342G) (herein referred to as "reservoirs" or "subject devices") are sterile medication containers designed for single use. The reservoirs are a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring the subcutaneous administration of insulin to maintain acceptable blood glucose levels. The reservoirs are indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps (i.e., Paradigm pumps and NGP pumps) and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets. The reservoirs have the same principle of operation as the predicate devices (MMT-326A, MMT-332A, MMT-342, MMT-342G) and are designed to mechanically connect to compatible infusion sets. Reservoirs are connected to the infusion set via the tubing connector (H-Cap), which enables insulin infusion from the reservoir through a fluid path into the subcutaneous tissue.
This document describes a 510(k) premarket notification for Medtronic MiniMed's Extended Reservoir and MiniMed Reservoir. The purpose of the submission is to qualify an additional sterilization site and an optimized ethylene oxide (EO) sterilization cycle for these devices.
Here's an analysis of the provided text in response to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "The test results demonstrate the subject devices met all the product requirements and specifications of the predicate devices." and "Medtronic concludes the reservoirs can be sterilized at the additional facility using the optimized parameters for EO sterilization cycle."
The acceptance criteria are implicitly defined by the product requirements and specifications of the predicate devices. The performance reported is that the subject devices met these predicate device requirements/specifications.
The relevant performance data from the text is summarized as follows:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical properties and function (as per predicate device) | Met all product requirements and specifications of the predicate devices following the new sterilization cycle and at the new site. The new sterilization process does not impact the product's material, performance, and shelf-life. |
| Material integrity and compatibility (as per predicate device) | Met all product requirements and specifications of the predicate devices following the new sterilization cycle and at the new site. The new sterilization process does not impact the product's material, performance, and shelf-life. |
| Shelf-life stability (as per predicate device) | Met all product requirements and specifications of the predicate devices following the new sterilization cycle and at the new site. The new sterilization process does not impact the product's material, performance, and shelf-life. |
| Sterility Assurance Level (SAL) | Maintained at 10^-6 (Same as predicate). |
| Biocompatibility | Non-toxic, non-pyrogenic; meets ISO 10993 (Same as predicate). |
| Risk Analysis | A risk analysis assessment was performed to evaluate and identify potential new hazards and failure modes related to the use of the reservoirs following sterilization at the new site under the new cycle parameters. Medtronic concludes that the use of the reservoirs sterilized at the new site under the optimized EO cycle does not raise any additional questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "The testing was performed on MMT-332A since the subject devices have the same hardware design, materials, and attributes as the predicate device."
- Sample Size: The document does not specify the exact sample size (number of units) used for the verification testing. It only mentions that the testing was performed on "MMT-332A" (a 3.0mL MiniMed Reservoir).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's "verification testing," it would typically be prospective data generated by Medtronic as part of the submission process. Medtronic MiniMed is located in Northridge, CA, USA, and the contract manufacturer and one sterilization site are in Puerto Rico, so the data likely originated from these locations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this submission. The device is an infusion pump accessory, and the testing focuses on the impact of a sterilization process change on the device's physical, chemical, and functional attributes, as well as its sterility. It does not involve human interpretation or diagnostic performance where experts establish a "ground truth" in the diagnostic sense. The "ground truth" here is the established product requirements and specifications of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results, where multiple experts provide opinions that may need to be reconciled to establish a ground truth. The testing described here is engineering and sterilization validation, which does not involve such an adjudication process.
5. 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 is not applicable. An MRMC study is relevant for AI-powered diagnostic or screening devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Medtronic reservoirs are physical medical devices, and the submission is about a sterilization process change, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm or software. It is a physical medical device (reservoir) for insulin delivery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is the established product requirements and specifications of the predicate devices (MiniMed Reservoir 1.8mL (MMT-326A), MiniMed Reservoir 3.0mL (MMT-332A), and Extended Reservoir (MMT-342, MMT-342G)). The verification testing aimed to demonstrate that the subject devices, after the sterilization change, still meet these existing, validated performance standards.
8. The sample size for the training set
This is not applicable. This is not a machine learning or AI device that requires a training set. The submission concerns changes to a manufacturing process (sterilization) for an existing medical device.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device submission.
§ 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).