(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
-
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 6, 2022
Medtronic MiniMed, Inc. Christina Rowe Senior Regulatory Affairs Manager 18000 Devonshire Street Northridge, California 91325
Re: K210714
Trade/Device Name: Extended Reservoir Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LZG Dated: December 17, 2021 Received: December 17, 2021
Dear Christina Rowe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210714
Device Name Extended Reservoir
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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510(k) Summary
Extended Reservoir
| Device Trade/ Generic Name | Extended Reservoir |
|---|---|
| Predicate Device Name andModel ID | Medtronic MiniMed Paradigm Reservoir MMT-332A (3.0mL) |
| Predicate 510(K) Number | K032005 |
| Classification Name | Class IIInfusion Pump Accessory |
| Pro Code | LZG |
| Cite | 21 CFR 880.5725 |
| Applicant RegistrationNumber | 2032227 |
| Manufacturer and DesignFacility | Medtronic MiniMed, Inc.18000 Devonshire StreetNorthridge, CA 91325 USA |
| Manufacturing Facility | Medtronic Puerto Rico Operations Co. (MPROC)Road 31, KM 24, HM 4Ceiba Norte Industrial ParkJuncos, Puerto Rico 00777 |
| Establishment Number | 3004209178 |
| Primary Contact Information | Christina RoweSenior Regulatory Affairs ManagerTel: (818) 942-4875 Fax: (818) 576-6273Email : christina.rowe@medtronic.com |
| Secondary ContactInformation | Darin S. OppenheimerSenior Regulatory Affairs DirectorTel: (609) 500-9672Email: darin.s.oppenheimer@medtronic.com |
Table 1-1: General Information
1. Device Description
Extended Reservoir (herein referred to as "EWR" or "MMT-342") is a sterile medication container (Figure 1-1) designed for single use.
Figure 1-1: Extended Reservoir with Transfer Guard
Image /page/3/Picture/7 description: The image shows a Medtronic syringe with a blue cap. The syringe is clear and has black markings on it. The cap is attached to the syringe and is also clear. The syringe is lying on a white surface.
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
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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.
Principle of Operations
The subject device (MMT-342) has the same principle of operation as the predicate device (MMT-332A). Same as the predicate device (MMT-332A), the subject device (MMT-342) is designed to mechanically connect to compatible infusion sets (Medtronic Extended Wear Infusion Sets, i.e., EWIS). The reservoir is 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.
The subject device (MMT-342) shares all attributes of the predicate device (MMT-332A), including the same intended use, same technological characteristics (i.e., hardware design, material, chemical composition, energy source etc.), same 3.0mL storage reservoir, and has the same principle of operation as the marketed predicate device (MMT-332A cleared by FDA under K032005). The change is limited to extending the duration of the reservoirs use (from up to 3 days to up to 7 days).
An exploded view of the subject device (MMT-342) is presented in Figure 1-2 while its components are provided in Table 1-2.
Image /page/4/Figure/5 description: This image shows an exploded diagram of a medical syringe. The different parts of the syringe are labeled, including the barrel, plunger rod, stopper, and O-ring. The barrel is labeled as 3.0 mL. Other labeled parts include the septum, snap cap, and transfer guard.
Figure 1-2: Extended Reservoir with Transfer Guard
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| Component | Definition |
|---|---|
| Plunger Rod | Rigid handle which can be used to move the stopper forthe purposes of filling the reservoir with medication. |
| Ribbed Stopper | Movable sealing member within the reservoir which isdriven by the pump mechanism to deliver medication. |
| O-Ring | Provides support between the stopper-to-barrel assembliesas it serves as an interface to prevent leaks. |
| Septum | Elastomeric, static closure mounted on the barrel end. Theseptum is to be penetrated with a needle, and seals aroundit for filling and infusion. |
| Transfer Guard | A plastic component encapsulating a hypodermic needle,designed to facilitate filling of the reservoir from a vial andto reduce needle-stick probability. |
| Snap Cap | Connects to the infusion set |
| Barrel | Stores the insulin. |
Table 1-2: Reservoir Components Definitions
2. 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.
3. Technological Characteristics and Substantial Equivalence (SE)
The scope of the subject device (MMT-342) is limited to extending the duration of reservoir use (from up to 3 days to up to 7 days). The hardware design of the subject device MMT-342 is the same as the predicate device MMT-332A (K032005). Please note that there are no changes in the hardware design, manufacturing, packaging, sterilization processes, fluid capacity, insulin compatibility, reservoir assembly, between the predicate MMT-332A (K032005) and the subject device (MMT-342). The change is limited to extending the duration of reservoir use (from up to 3 days to up to 7 days) as shown in Table 1-3.
A Substantially Equivalent (SE) chart of the similarities and differences between the predicate device (MMT-332A) and the subject device (MMT-342) is shown in Table 1-3.
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Table 1-3: Comparision of Predicate Device MiniMed Reservoir MMT-332A (K032005) to the Subject Device Extended Reservoir MMT-342
| Specification | MiniMed Reservoir(Predicate Device)MMT-332A (K032005) | Extended Reservoir(Subject Device)MMT-342 | Comparison |
|---|---|---|---|
| Type of Device | User-filled Reservoir | User-filled Reservoir | Same |
| Intended Use | This reservoir is indicated for thesubcutaneous infusion of medication,including insulin, from compatibleMedtronic insulin pumps and infusionsets. Refer to your Medtronic insulinpump user guide for compatibility. | The Extended Reservoir is indicatedfor the subcutaneous infusion ofmedication, including insulin, fromcompatible Medtronic insulin pumpsand infusion sets. Refer to yourMedtronic insulin pump user guide fora list of compatible insulins andinfusion sets. | Different: theproduct name andmodel number forEWR is listed. Amore specificstatement aboutcompatible insulins /infusion sets is alsodescribed. |
| Contraindication | This reservoir is contraindicated for theinfusion of blood or blood products. | This reservoir is contraindicated for theinfusion of blood or blood products. | Same |
| Duration of use | Up to 3 days | Up to 7 days | Different: Theduration of use hasincreased from 3 to 7days. |
| Principle ofOperations | Movable stopper | Movable stopper | Same |
| Nominal volume | 3.0mL (2.7mL usable) | 3.0mL (2.7mL usable) | Same |
| Filling Method | Transfer Guard with needle | Transfer Guard with needle | Same |
| ReservoirLength (Barrel) | 4.34cm (1.707in) | 4.34cm (1.707in) | Same |
| Filling NeedleMaterial | 304 stainless steel | 304 stainless steel | Same |
| Filling needlelength | 0.74in | 0.74in | Same |
| Filling NeedleGauge | 26 gauge | 26 gauge | Same |
| Needle TipConfiguration | Beveled | Beveled | Same |
| Biocompatibility | Non-toxic, non-pyrogenic; meets ISO10993 | Non-toxic, non-pyrogenic; meets ISO10993 | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| SterilizationAssurance Level(SAL) | 10-6 | 10-6 | Same |
| Specific DrugUse | Medication labeled for subcutaneousadministration | Medication labeled for subcutaneousadministration | Same |
| InsulinCompatibility | Humalog®/Novolog® | Humalog®/Novolog® | Same |
| Plunger Material | Polypropylene (only for filling) | Polypropylene (only for filling) | Same |
| Barrel Materialand Markings | Polypropylene0.2mL increments | Polypropylene0.2mL increments | Same |
| BarrelTransparency | Translucent | Translucent | Same |
| Shelf Life | 3 years | 3 years | Same |
| Packaging | 10 each / customer box720 each / shipper case | 10 each / customer box720 each / shipper case | Same |
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For the reviewer's convenience, Medtronic is providing a reservoir components comparison (Table 1-4) between the predicate device (MMT-332A) and the subject device (MMT-342). The comparison demonstrates that the subject device (MMT-342) utilizes the same hardware design elements as the predicate device (MMT-332A) and highlights the fundamental difference limited to extending the duration of reservoir use (from up to 3 days to up to 7 days).
| ReservoirDesignElements | Predicate Device:MiniMed ReservoirMMT-332A (K032005) | Subject Device:Extended ReservoirMMT-342 | Comparison |
|---|---|---|---|
| Model Number | MMT-332A | MMT-342 | |
| Volume | 3.0mL | 3.0mL | Same |
| Part Number | 7005317J002 | 7005317J002 | Same |
| Plunger Rod | 6014747-006 | 6014747-006 | Same |
| Ribbed Stopper | 6015400-002 | 6015400-002 | Same |
| O-Ring | D60144995-005 | D60144995-005 | Same |
| Barrel | 7005291J003 | 7005291J003 | Same |
| Lubricant | D8062007-001 | D8062007-001 | Same |
| Septum | D6014713-004 | D6014713-004 | Same |
| Transfer Guard | 7005176J-001 | 7005176J-001 | Same |
| Snap Cap | 6015129-001 | 6015129-001 | Same |
Table 1-4: Reservoir Components Comparison
4. Performance Data
Medtronic performed verification testing to support extending the duration of the reservoirs use (from up to 3 days to up to 7 days). The verification testing was performed on MMT-332A (predicate device) since the MMT-342 (subject device) has the same hardware design, materials, and attributes as the predicate device (MMT-332A) except for extending the duration of the reservoirs use (from up to 3 days to up to 7 days). The test results demonstrate that MMT-342 (subject device) met all the product requirements and specifications of MMT-332A (predicate
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device). Additionally, Medtronic performed a risk analysis assessment to evaluate and identify potentially new hazards and failure modes related to the use of MMT-342 (subject device) for the extended duration (up to 7 days).
Based on the results. Medtronic concludes that the use of MMT-342 (subject device) for the extended duration of up to 7 days does not raise any additional questions of safety and effectiveness.
5. Substantial Equivalence
Based on the 510(k)-summary information provided herein, Medtronic concludes that the MMT-342 (subject device), is substantially equivalent to MMT-332A (predicate device) in its intended use, safety, effectiveness, and underlying scientific and operating principles. Medtronic would like to reiterate the fundamental difference between the MMT-332A (predicate) and MMT-342 (subject device) is limited to extending the reservoir duration of use (from up to 3 days to up to 7 days).
6. Conclusions
In conclusion, the proposed change is limited to extending the reservoir duration of use (from up to 3 days to up to 7 days). As stated previously, MMT-342 (subject device) has the same intended use, same hardware design, same technological characteristics (i.e., hardware design, material, chemical composition, energy source), same 3.0mL storage reservoir, and same principle of operation as the MMT-332A (predicate device). Medtronic performed verification testing to support extending the reservoir duration of use (up to 7 days). The test results demonstrated that MMT-342 (subject device) met all the product requirements and intended use. Additionally, Medtronic performed risk analysis assessment to identify potential new hazards and failure modes related to the extended duration of use of MMT-342 (subject device) compared to MMT-332A (predicate device).
Based on the results, Medtronic concludes MMT-342 (subject device) can have an extended duration of use (up to 7 days) and does not raise any additional questions of safety and effectiveness when compared to the MMT-332A (predicate device). Therefore, the subject device (MMT-342) is substantially equivalent to the legally marketed predicate device (MMT-332A (K032005)).
§ 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).