Extended Reservoir; MiniMed Reservoir

K241622 · Medtronic Minimed · LZG · Jul 2, 2024 · General Hospital

Device Facts

• Record ID: K241622
• Device Name: Extended Reservoir; MiniMed Reservoir
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: Jul 2, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Single-use sterile medication reservoir; component of Medtronic insulin pump delivery system. User fills reservoir from medication vial using integrated transfer guard with needle; reservoir connects to pump mechanism via H-Cap tubing connector. Movable stopper driven by pump mechanism delivers insulin through infusion set into subcutaneous tissue. Used by patients with diabetes mellitus to maintain blood glucose levels. Device hardware, materials, and principle of operation identical to predicates; change limited to qualification of additional sterilization site and optimized ethylene oxide (EO) sterilization cycle. Benefits include maintained safety and effectiveness with improved sterilization process efficiency.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities were performed based on risk analysis to confirm the impact of the new sterilization cycle, location, and release process.

Technological Characteristics

Sterile, single-use reservoir. Materials: barrel (plastic), septum (elastomeric), plunger rod, ribbed stopper, O-ring, transfer guard. Filling: 26-gauge, 0.74-inch beveled 304 stainless steel needle. Sterilization: Ethylene Oxide (EO) at alternate site with optimized cycle parameters. Biocompatibility: ISO 10993 compliant. Capacity: 1.8mL or 3.0mL. No electronic components or software.

Indications for Use

Indicated for subcutaneous infusion of medication, including insulin, in patients with diabetes mellitus requiring insulin therapy via compatible Medtronic insulin pumps and infusion sets. Contraindicated for infusion of blood and blood products.

Regulatory Classification

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.

Predicate Devices

• MiniMed Reservoir 1.8mL (MMT-326A) (K001828)
• MiniMed Reservoir 3.0mL (MMT-332A) (K032005)
• Extended Reservoir (MMT-342, MMT-342G) (K210714)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K241622

B Applicant

Medtronic MiniMed

C Proprietary and Established Names

Extended Reservoir; MiniMed Reservoir

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LZG | Class II | 21 CFR 880.5725 - Infusion pump | CH – Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II devices requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: MiniMed Paradigm Reservoirs, 1.8mL (K001828) and 3.0mL (K032005) and MiniMed Extended Reservoir (K210714).
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

a. Introducing a new sterilization cycle.
b. Introducing a new sterilization location.
c. Introducing a new sterilization release process.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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