Extended Reservoir

K210714 · Medtronic Minimed, Inc. · LZG · Apr 6, 2022 · General Hospital

Device Facts

• Record ID: K210714
• Device Name: Extended Reservoir
• Applicant: Medtronic Minimed, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Apr 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Extended 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 a list of compatible insulins and infusion sets.

Device Story

Extended Reservoir is a sterile, single-use 3.0 mL medication container for Medtronic insulin pumps; facilitates subcutaneous insulin delivery for patients with diabetes mellitus. Device mechanically connects to compatible infusion sets (e.g., Medtronic Extended Wear Infusion Set). Modification from predicate allows 7-day wear duration versus 3-day. Used by patients in home/clinical settings; operated by patient. Output is controlled insulin delivery; healthcare provider uses output to maintain glycemic control. Benefits include reduced frequency of reservoir changes and improved patient convenience.

Clinical Evidence

Bench testing only. Verification testing performed on the predicate device design confirmed that the reservoir meets all product requirements and specifications for an extended 7-day duration of use. Risk analysis assessment identified no new hazards or failure modes associated with the extended duration.

Technological Characteristics

Sterile, single-use 3.0 mL reservoir. Mechanical connection to infusion sets. Ethylene oxide sterilization. Complies with ISO 10993 series for biocompatibility and ISO 14971 for risk management. No electronic or software components; purely mechanical fluid container.

Indications for Use

Indicated for patients with diabetes mellitus requiring subcutaneous insulin infusion via compatible Medtronic insulin pumps. Contraindicated for use with two or three-day infusion sets; must be used with Medtronic Extended infusion sets.

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

• Medtronic MiniMed Paradigm Reservoir Model MMT-332A (K032005)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K210714

B Applicant

Medtronic MiniMed, Inc.

C Proprietary and Established Names

Extended Reservoir

D Regulatory Information

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

E Purpose for Submission:

Modification of a previously cleared reservoir for extending the duration of use to up to 7 days.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The Extended 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 a list of compatible insulins and infusion sets.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K210714 - Page 2 of 4

C Special Conditions for Use Statement(s):

Rx – For Prescription Use Only

The pump reservoir should be used for a maximum of seven days, or according to the insulin labeling, whichever is shorter.

Do not use with two or three day infusion sets. The reservoir may only be used for up to seven days with use of the Medtronic Extended infusion set. Use of the reservoir with two or three day infusion sets may lead to hyperglycemia or diabetic ketoacidosis.

If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly fill the infusion set. This may result in the delivery of too little or too much insulin, which can cause hyperglycemia or hypoglycemia. If this occurs, start over with a new reservoir and infusion set.

III Device Description

The Extended Reservoir is a sterile medication container designed for single use. The device 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 device is designed to mechanically connect to compatible infusion sets (e.g., Medtronic Extended Wear Infusion Set, K210544). The Medtronic MiniMed Extended Reservoir has a 3.0 mL storage capacity and is indicated for use for up to 7 days.

IV Substantial Equivalence Information:

A Predicate Device Name(s):

Medtronic MiniMed Paradigm Reservoir Model MMT-332A

B Predicate 510(k) Number(s):

K032005

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K210714 | K032005 |
| --- | --- | --- |
| Device Trade Name | Extended Reservoir | Medtronic MiniMed Paradigm Reservoir MMT-332A |
| General Device Characteristic Similarities | | |
| Intended Use | Subcutaneous infusion of medication, including insulin, from | Same |

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| | compatible Medtronic insulin pumps and infusion sets. | |
| --- | --- | --- |
| Sterilization Method | Ethylene Oxide | Same |
| Insulin Compatibility | Humalog (insulin lispro) and Novolog (insulin aspart) | Same |
| Shelf Life | 3 years | Same |
| Nominal Volume | 3 mL | Same |
| General Device Characteristic Differences | | |
| Duration of Use | Up to 7 days | Up to 3 days |

V Standards/Guidance Documents Referenced:

ISO 14971:2019, Medical devices – Application of risk management to medical devices

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing

ISO 10993-3:2014, Biological Evaluation of Medical Devices – Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity

ISO 10993-4:2017, Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood

ISO 10993-5:2009, Biological Evaluation of Medical Devices – Part 5: Tests for in-vitro Cytotoxicity

ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residual

ISO 10993-10:2010, Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization

ISO 10993-11:2017, Biological Evaluation of Medical Devices – Part 11: Tests for systemic toxicity

ISO 10993-12:2012, Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials

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ISO 10993-17:2002, Biological Evaluation of Medical Devices – Part 17: Establishment of Allowable Limits for Leachable Substances

ISO 10993-18:2009, Biological Evaluation of Medical Devices – Part 18: Chemical characterization of materials

## VI Performance Characteristics:

The sponsor conducted analytical performance tests to evaluate the modified device. The following analytical performance tests were provided:

- Insulin compatibility testing
- Storage and operating conditioning
- Service life testing
- Gravity leak testing
- Occlusion sensitivity

The sponsor also provided the results of biocompatibility testing in accordance with ISO 10993-1 and FDA guidance on the use of this standard. The results of this testing support a finding of substantial equivalence.

## VII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## VIII Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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